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Effectiveness of Dance on Patients With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00961805
Recruitment Status : Completed
First Posted : August 19, 2009
Results First Posted : August 19, 2009
Last Update Posted : August 25, 2009
Sponsor:
Information provided by:
Federal University of São Paulo

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Fibromyalgia
Interventions Behavioral: Dance
Other: Control Group
Enrollment 80

Recruitment Details 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  
Arm/Group Title Control Group Dance Group
Hide Arm/Group Description 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). 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.
Period Title: Overall Study
Started 40 40
Completed 40 40
Not Completed 0 0
Arm/Group Title Group Control Dance Group Total
Hide Arm/Group Description The waiting list 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 of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
40
 100.0%
40
 100.0%
80
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
49.1  (11.5) 49.5  (10.9) 49.3  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
40
 100.0%
40
 100.0%
80
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 40 participants 40 participants 80 participants
40 40 80
1.Primary Outcome
Title Visual Analog Scale for Pain
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Dance Group
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: mm
Baseline 75  (13) 75  (17)
After 16 weeks 75  (14) 46  (20)
After 32 weeks 73  (17) 47  (26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Dance Group
Comments

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.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Differences in the behavior of the groups over time.
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Function - 6 Minute Walk Test
Hide Description meters traveled on a 20-meter course over a six-minute period
Time Frame baseline, after 16 weeks and after 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Dance Group
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: meters
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Dance Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Differences in the behavior of the groups over time.
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Quality of Life - Fibromyalgia Impact Questionnaire
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Dance Group
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Dance Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.003
Comments Differences in the behavior of the groups over time.
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Quality of Life - SF-36 -Functional Capacity
Hide Description score between 0 from 100, with higher scores denoting better quality of life
Time Frame baseline, after 16 weeks and after 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Dance Group
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Dance Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.146
Comments Differences in the behavior of the groups over time.
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Quality of Life - SF-36 - Physical Limitation
Hide Description score between 0 from 100, with higher scores denoting better quality of life
Time Frame baseline, after 16 weeks and after 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Dance Group
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Dance Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.131
Comments Differences in the behavior of the groups over time.
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Quality of Life - Sf-36 - Pain
Hide Description score between 0 from 100, with higher scores denoting better quality of life
Time Frame baseline, after 16 weeks and after 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Dance Group
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Dance Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Differences in the behavior of the groups over time.
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Quality of Life - Sf-36 - General Health State
Hide Description score between 0 from 100, with higher scores denoting better quality of life
Time Frame baseline, after 16 weeks and after 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Dance Group
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Dance Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.580
Comments Differences in the behavior of the groups over time.
Method ANOVA
Comments [Not Specified]
8.Secondary Outcome
Title Quality of Life - SF-36 - Vitality
Hide Description score between 0 from 100, with higher scores denoting better quality of life
Time Frame baseline, after 16 weeks and after 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Dance Group
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Dance Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments Differences in the behavior of the groups over time.
Method ANOVA
Comments [Not Specified]
9.Secondary Outcome
Title Quality of Life - SF-36 - Social Aspects
Hide Description score between 0 from 100, with higher scores denoting better quality of life
Time Frame baseline, after 16 weeks and after 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Dance Group
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Dance Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments Differences in the behavior of the groups over time.
Method ANOVA
Comments [Not Specified]
10.Secondary Outcome
Title Quality of Life - SF-36 - Emotional Aspects
Hide Description score between 0 from 100, with higher scores denoting better quality of life
Time Frame baseline, after 16 weeks and after 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Dance Group
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Dance Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments Differences in the behavior of the groups over time.
Method ANOVA
Comments [Not Specified]
11.Secondary Outcome
Title Quality of Life - SF-36 - Mental Health
Hide Description score between 0 from 100, with higher scores denoting better quality of life
Time Frame baseline, after 16 weeks and after 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Dance Group
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Dance Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments Differences in the behavior of the groups over time.
Method ANOVA
Comments [Not Specified]
12.Secondary Outcome
Title Depression - Beck Inventory
Hide Description score between 0 from 63, with higher score indicating greater depression
Time Frame Baseline, after 16 weeks and after 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Dance Group
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Dance Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.136
Comments Differences in the behavior of the groups over time.
Method ANOVA
Comments [Not Specified]
13.Secondary Outcome
Title Self-image - Body Dysmorphic Disorder Examination Questionnaire
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Dance Group
Hide Arm/Group Description:
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).
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Dance Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments Differences in the behavior of the groups over time.
Method ANOVA
Comments [Not Specified]
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.
Results Point of Contact
Name/Title: Andreia S Baptista, PT
Organization: Federal University of Sao Paulo
Phone: 551155764239
Responsible Party: Andreia Salvador Baptista, Federal Unversity of Sao Paulo
ClinicalTrials.gov Identifier: NCT00961805     History of Changes
Other Study ID Numbers: 1044/06
First Submitted: April 30, 2009
First Posted: August 19, 2009
Results First Submitted: April 30, 2009
Results First Posted: August 19, 2009
Last Update Posted: August 25, 2009