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Effectiveness of Dance on Patients With Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00961805
First received: April 30, 2009
Last updated: August 19, 2009
Last verified: August 2009
History of Changes
Results First Received: April 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Fibromyalgia
Interventions: Behavioral: Dance
Other: Control Group

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment of patients started in August 2007 and finished in April 2008. The recruitment was made in Sao Paulo Hospital division of Rheumatology

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control Group The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
Dance Group The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.

Participant Flow:   Overall Study
    Control Group     Dance Group  
STARTED     40     40  
COMPLETED     40     40  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Group Control The waiting list
Dance Group The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home
Total Total of all reporting groups

Baseline Measures
    Group Control     Dance Group     Total  
Number of Participants  
[units: participants]
 		  40     40     80  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     40     40     80  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  49.1  ± 11.5     49.5  ± 10.9     49.3  ± 11.2  
Gender  
[units: participants]
 		     
Female     40     40     80  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
Brazil     40     40     80  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Visual Analog Scale for Pain   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

Measure Type Primary
Measure Title Visual Analog Scale for Pain
Measure Description score between 0 and 100 where 0 is no pain and 100 in unbearable pain
Time Frame baseline, after 16 weeks and after 32 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Group The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
Dance Group The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.

Measured Values
    Control Group     Dance Group  
Number of Participants Analyzed  
[units: participants]
 		  40     40  
Visual Analog Scale for Pain  
[units: mm]
Mean ± Standard Deviation 		   
Baseline     75  ± 13     75  ± 17  
After 16 weeks     75  ± 14     46  ± 20  
After 32 weeks     73  ± 17     47  ± 26  


Statistical Analysis 1 for Visual Analog Scale for Pain
Groups [1] All groups
Method [2] ANOVA
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

Sample size was calculated by visual analogue scale for pain (alpha error of 5%, beta error of 20% and standard deviation of 2). The sample was determined to contain 30 patients in each group. Ten additional patients were added to compensate possible losses.

Analysis was intention to treat using the LOCF technique.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Differences in the behavior of the groups over time.



2.  Secondary:   Function - 6 Minute Walk Test   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

Measure Type Secondary
Measure Title Function - 6 Minute Walk Test
Measure Description meters traveled on a 20-meter course over a six-minute period
Time Frame baseline, after 16 weeks and after 32 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Group The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
Dance Group The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.

Measured Values
    Control Group     Dance Group  
Number of Participants Analyzed  
[units: participants]
 		  40     40  
Function - 6 Minute Walk Test  
[units: meters]
Mean ± Standard Deviation 		   
Baseline     332  ± 66.7     372.8  ± 80.2  
after 16 weeks     344.3  ± 72.7     443.5  ± 78.3  
after 32 weeks     343  ± 77.9     431  ± 88.7  


Statistical Analysis 1 for Function - 6 Minute Walk Test
Groups [1] All groups
Method [2] ANOVA
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Differences in the behavior of the groups over time.



3.  Secondary:   Quality of Life - Fibromyalgia Impact Questionnaire   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

Measure Type Secondary
Measure Title Quality of Life - Fibromyalgia Impact Questionnaire
Measure Description score between 0 from 10 with 0 indicating no impairment and 10 indicating maximum impairment
Time Frame baseline, after 16 weeks and after 32 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Group The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
Dance Group The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.

Measured Values
    Control Group     Dance Group  
Number of Participants Analyzed  
[units: participants]
 		  40     40  
Quality of Life - Fibromyalgia Impact Questionnaire  
[units: units on a scale]
Mean ± Standard Deviation 		   
Baseline     6.34  ± 1.29     5.89  ± 1.39  
After 16 weeks     6.61  ± 1.53     4.69  ± 1.73  
After 32 weeks     5.9  ± 1.86     4.26  ± 1.81  


Statistical Analysis 1 for Quality of Life - Fibromyalgia Impact Questionnaire
Groups [1] All groups
Method [2] ANOVA
P Value [3] <0.003
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Differences in the behavior of the groups over time.



4.  Secondary:   Quality of Life - SF-36 -Functional Capacity   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

Measure Type Secondary
Measure Title Quality of Life - SF-36 -Functional Capacity
Measure Description score between 0 from 100, with higher scores denoting better quality of life
Time Frame baseline, after 16 weeks and after 32 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Group The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
Dance Group The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.

Measured Values
    Control Group     Dance Group  
Number of Participants Analyzed  
[units: participants]
 		  40     40  
Quality of Life - SF-36 -Functional Capacity  
[units: units on a scale]
Mean ± Standard Deviation 		   
Baseline     32.6  ± 18.9     44.9  ± 18.9  
After 16 weeks     33.1  ± 18.6     52.9  ± 21.1  
After 32 weeks     39.1  ± 22     56.3  ± 19.9  


Statistical Analysis 1 for Quality of Life - SF-36 -Functional Capacity
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.146
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Differences in the behavior of the groups over time.



5.  Secondary:   Quality of Life - SF-36 - Physical Limitation   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

Measure Type Secondary
Measure Title Quality of Life - SF-36 - Physical Limitation
Measure Description score between 0 from 100, with higher scores denoting better quality of life
Time Frame baseline, after 16 weeks and after 32 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Group The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
Dance Group The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.

Measured Values
    Control Group     Dance Group  
Number of Participants Analyzed  
[units: participants]
 		  40     40  
Quality of Life - SF-36 - Physical Limitation  
[units: units on a scale]
Mean ± Standard Deviation 		   
Baseline     8.8  ± 17.9     24.7  ± 32.2  
After 16 weeks     10.4  ± 21.6     40.5  ± 30.6  
After 32 weeks     13.8  ± 26.5     36.5  ± 13.8  


Statistical Analysis 1 for Quality of Life - SF-36 - Physical Limitation
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.131
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Differences in the behavior of the groups over time.



6.  Secondary:   Quality of Life - Sf-36 - Pain   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

Measure Type Secondary
Measure Title Quality of Life - Sf-36 - Pain
Measure Description score between 0 from 100, with higher scores denoting better quality of life
Time Frame baseline, after 16 weeks and after 32 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Group The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
Dance Group The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.

Measured Values
    Control Group     Dance Group  
Number of Participants Analyzed  
[units: participants]
 		  40     40  
Quality of Life - Sf-36 - Pain  
[units: units on a scale]
Mean ± Standard Deviation 		   
Baseline     25.7  ± 13.4     29.6  ± 17.5  
After 16 weeks     25.1  ± 14.2     44.7  ± 20.7  
After 32 weeks     29.1  ± 21.1     46  ± 19.2  


Statistical Analysis 1 for Quality of Life - Sf-36 - Pain
Groups [1] All groups
Method [2] ANOVA
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Differences in the behavior of the groups over time.



7.  Secondary:   Quality of Life - Sf-36 - General Health State   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

Measure Type Secondary
Measure Title Quality of Life - Sf-36 - General Health State
Measure Description score between 0 from 100, with higher scores denoting better quality of life
Time Frame baseline, after 16 weeks and after 32 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Group The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
Dance Group The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.

Measured Values
    Control Group     Dance Group  
Number of Participants Analyzed  
[units: participants]
 		  40     40  
Quality of Life - Sf-36 - General Health State  
[units: units on a scale]
Mean ± Standard Deviation 		   
Baseline     38  ± 16.5     46  ± 21.7  
After 16 weeks     38.1  ± 18.3     45  ± 21.3  
After 32 weeks     41.5  ± 21.4     44.9  ± 15.6  


Statistical Analysis 1 for Quality of Life - Sf-36 - General Health State
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.580
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Differences in the behavior of the groups over time.



8.  Secondary:   Quality of Life - SF-36 - Vitality   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

Measure Type Secondary
Measure Title Quality of Life - SF-36 - Vitality
Measure Description score between 0 from 100, with higher scores denoting better quality of life
Time Frame baseline, after 16 weeks and after 32 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Group The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
Dance Group The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.

Measured Values
    Control Group     Dance Group  
Number of Participants Analyzed  
[units: participants]
 		  40     40  
Quality of Life - SF-36 - Vitality  
[units: units on a scale]
Mean ± Standard Deviation 		   
Baseline     29  ± 18.2     41.3  ± 18.8  
After 16 weeks     30.7  ± 18.1     50  ± 22.8  
After 32 weeks     37.1  ± 21.8     47.6  ± 24.5  


Statistical Analysis 1 for Quality of Life - SF-36 - Vitality
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.082
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Differences in the behavior of the groups over time.



9.  Secondary:   Quality of Life - SF-36 - Social Aspects   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

Measure Type Secondary
Measure Title Quality of Life - SF-36 - Social Aspects
Measure Description score between 0 from 100, with higher scores denoting better quality of life
Time Frame baseline, after 16 weeks and after 32 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Group The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
Dance Group The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.

Measured Values
    Control Group     Dance Group  
Number of Participants Analyzed  
[units: participants]
 		  40     40  
Quality of Life - SF-36 - Social Aspects  
[units: units on a scale]
Mean ± Standard Deviation 		   
Baseline     47.6  ± 23.1     52.6  ± 27.7  
After 16 weeks     47.6  ± 24.5     64.1  ± 28  
After 32 weeks     51.3  ± 25.5     57.2  ± 27  


Statistical Analysis 1 for Quality of Life - SF-36 - Social Aspects
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.055
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Differences in the behavior of the groups over time.



10.  Secondary:   Quality of Life - SF-36 - Emotional Aspects   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

Measure Type Secondary
Measure Title Quality of Life - SF-36 - Emotional Aspects
Measure Description score between 0 from 100, with higher scores denoting better quality of life
Time Frame baseline, after 16 weeks and after 32 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Group The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
Dance Group The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.

Measured Values
    Control Group     Dance Group  
Number of Participants Analyzed  
[units: participants]
 		  40     40  
Quality of Life - SF-36 - Emotional Aspects  
[units: units on a scale]
Mean ± Standard Deviation 		   
Baseline     21.2  ± 33.1     34.2  ± 36.9  
After 16 weeks     17.5  ± 26.1     55  ± 33.6  
After 32 weeks     31.5  ± 38.7     51.9  ± 39.6  


Statistical Analysis 1 for Quality of Life - SF-36 - Emotional Aspects
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.003
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Differences in the behavior of the groups over time.



11.  Secondary:   Quality of Life - SF-36 - Mental Health   [ Time Frame: baseline, after 16 weeks and after 32 weeks ]

Measure Type Secondary
Measure Title Quality of Life - SF-36 - Mental Health
Measure Description score between 0 from 100, with higher scores denoting better quality of life
Time Frame baseline, after 16 weeks and after 32 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Group The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
Dance Group The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.

Measured Values
    Control Group     Dance Group  
Number of Participants Analyzed  
[units: participants]
 		  40     40  
Quality of Life - SF-36 - Mental Health  
[units: units on a scale]
Mean ± Standard Deviation 		   
Baseline     43.4  ± 24     46  ± 19.9  
After 16 weeks     44.5  ± 26.6     54.2  ± 20.7  
After 32 weeks     46.2  ± 22.6     52.3  ± 20.8  


Statistical Analysis 1 for Quality of Life - SF-36 - Mental Health
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.021
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Differences in the behavior of the groups over time.



12.  Secondary:   Depression - Beck Inventory   [ Time Frame: Baseline, after 16 weeks and after 32 weeks ]

Measure Type Secondary
Measure Title Depression - Beck Inventory
Measure Description score between 0 from 63, with higher score indicating greater depression
Time Frame Baseline, after 16 weeks and after 32 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Group The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
Dance Group The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.

Measured Values
    Control Group     Dance Group  
Number of Participants Analyzed  
[units: participants]
 		  40     40  
Depression - Beck Inventory  
[units: units on a scale]
Mean ± Standard Deviation 		   
Baseline     21.2  ± 13     23.9  ± 14.7  
After 16 weeks     23.5  ± 11.5     20.2  ± 13.2  
After 32 weeks     23.5  ± 13.7     23.1  ± 15.3  


Statistical Analysis 1 for Depression - Beck Inventory
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.136
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Differences in the behavior of the groups over time.



13.  Secondary:   Self-image - Body Dysmorphic Disorder Examination Questionnaire   [ Time Frame: Baseline, after 16 weeks and after 32 weeks ]

Measure Type Secondary
Measure Title Self-image - Body Dysmorphic Disorder Examination Questionnaire
Measure Description scored between 0 from 168, with higher scores indicating greater level of dissatisfaction with self-image
Time Frame Baseline, after 16 weeks and after 32 weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Group The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
Dance Group The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.

Measured Values
    Control Group     Dance Group  
Number of Participants Analyzed  
[units: participants]
 		  40     40  
Self-image - Body Dysmorphic Disorder Examination Questionnaire  
[units: units on a scale]
Mean ± Standard Deviation 		   
Baseline     48.8  ± 34.2     42.8  ± 32.6  
After 16 weeks     50.5  ± 29.4     33.6  ± 25.9  
After 32 weeks     46.9  ± 31.8     41.1  ± 24.4  


Statistical Analysis 1 for Self-image - Body Dysmorphic Disorder Examination Questionnaire
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.009
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Differences in the behavior of the groups over time.




  Serious Adverse Events
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  Other Adverse Events
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Andreia S Baptista, PT
Organization: Federal University of Sao Paulo
phone: 551155764239
e-mail: deiasalvador1@yahoo.com.br


No publications provided by Federal University of São Paulo

Publications automatically indexed to this study:


Responsible Party: Andreia Salvador Baptista, Federal Unversity of Sao Paulo
ClinicalTrials.gov Identifier: NCT00961805     History of Changes
Other Study ID Numbers: 1044/06
Study First Received: April 30, 2009
Results First Received: April 30, 2009
Last Updated: August 19, 2009
Health Authority: Brazil: National Committee of Ethics in Research