Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia

This study has been completed.
Sponsor:
Collaborators:
Sahlgren´s University Hospital
Västra Götalands Forskningsfond
Reumatikerförbundet
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT00643006
First received: March 19, 2008
Last updated: September 28, 2012
Last verified: September 2012
Results First Received: May 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Exercise Therapy
Pain
Interventions: Behavioral: Physical exercise
Behavioral: Active comparator: low intensive exercise

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
A. High Intensive Exercise High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
B. Low-intensive Exercise Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks

Participant Flow:   Overall Study
    A. High Intensive Exercise     B. Low-intensive Exercise  
STARTED     34     33  
COMPLETED     29     29  
NOT COMPLETED     5     4  
Lost to Follow-up                 5                 4  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
A. High Intensive Exercise High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
B. Low-intensive Exercise Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
Total Total of all reporting groups

Baseline Measures
    A. High Intensive Exercise     B. Low-intensive Exercise     Total  
Number of Participants  
[units: participants]
  34     33     67  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     34     33     67  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  48  ± 7.8     50  ± 7.6     49  ± 7.7  
Gender  
[units: participants]
     
Female     34     33     67  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Sweden     34     33     67  



  Outcome Measures
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1.  Primary:   Six-minute Walk Test   [ Time Frame: 15 weeks ]

2.  Primary:   Change of Pain Level From Baseline.   [ Time Frame: 15 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
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Results Point of Contact:  
Name/Title: Dr. K Mannerkorpi
Organization: Gothenburg University
phone: 046-31-24220
e-mail: kaisa.mannerkorpi@rheuma.gu.se


No publications provided by Göteborg University

Publications automatically indexed to this study:

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT00643006     History of Changes
Other Study ID Numbers: GAU2
Study First Received: March 19, 2008
Results First Received: May 3, 2012
Last Updated: September 28, 2012
Health Authority: Sweden: Regional Ethical Review Board