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Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00643006
Recruitment Status : Completed
First Posted : March 25, 2008
Results First Posted : October 30, 2012
Last Update Posted : October 30, 2012
Sponsor:
Collaborators:
Sahlgren´s University Hospital
Västra Götalands Forskningsfond
Reumatikerförbundet
Information provided by (Responsible Party):
Göteborg University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Exercise Therapy
Pain
Interventions Behavioral: Physical exercise
Behavioral: Active comparator: low intensive exercise
Enrollment 67
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A. High Intensive Exercise B. Low-intensive Exercise
Hide Arm/Group Description High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
Period Title: Overall Study
Started 34 33
Completed 29 29
Not Completed 5 4
Reason Not Completed
Lost to Follow-up             5             4
Arm/Group Title A. High Intensive Exercise B. Low-intensive Exercise Total
Hide Arm/Group Description High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks Total of all reporting groups
Overall Number of Baseline Participants 34 33 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 67 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
34
 100.0%
33
 100.0%
67
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 33 participants 67 participants
48  (7.8) 50  (7.6) 49  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 67 participants
Female
34
 100.0%
33
 100.0%
67
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 34 participants 33 participants 67 participants
34 33 67
1.Primary Outcome
Title Six-minute Walk Test
Hide Description Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented.
Time Frame 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A. Exercise Arm B. Active Comparator
Hide Arm/Group Description:
The intervention group participated in Nordic walking
The active comparison group participated in low-intensive walks.
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: meter
37.7  (41.8) 8.6  (42.2)
2.Primary Outcome
Title Change of Pain Level From Baseline.
Hide Description Pain was measured by The Fibromyalgia Impact Questionnaire (FIQ) subscale for Pain, which is a self-rated pain on visual analogue scale, 0-100 mm. The higher value, the worse pain.
Time Frame 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients attending at post-test
Arm/Group Title A. High Intensive Exercise B. Low-intensive Exercise
Hide Arm/Group Description:
High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: mm
-4.0  (14.5) -5.3  (16.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A. High Intensive Exercise B. Low-intensive Exercise
Hide Arm/Group Description High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
All-Cause Mortality
A. High Intensive Exercise B. Low-intensive Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
A. High Intensive Exercise B. Low-intensive Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
A. High Intensive Exercise B. Low-intensive Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/33 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. K Mannerkorpi
Organization: Gothenburg University
Phone: 046-31-24220
EMail: kaisa.mannerkorpi@rheuma.gu.se
Layout table for additonal information
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT00643006    
Other Study ID Numbers: GAU2
First Submitted: March 19, 2008
First Posted: March 25, 2008
Results First Submitted: May 3, 2012
Results First Posted: October 30, 2012
Last Update Posted: October 30, 2012