The Effects of Training and Relaxation on Fibromyalgia.

Not Applicable

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT01226784
• Lead Sponsor: Karolinska Institutet

Brief Summary

Effects of physical training and relaxation exercise on pathophysiological mechanisms and symptoms in finbromyalgia patients.

Detailed Description

A multi-center trial examining the effects of progressive resistance group exercise compared with an active control group (relaxation). A person-centred model of exercise was used. The intervention was performed twice a week for 15 weeks and was supervised by experienced physiotherapists.

Secondary aims off this multi-center study was to improve the understanding of pain mechanisms in fibromyalgia and how these are affected by physical exercise. Please see references of published articles for details.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-21
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-22
• Primary Completion: 2015-05
• Status Verified: 2020-10
• Study Completion: 2020-10
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

ACR 1990 criteria for fibromyalgia -

Exclusion Criteria

Other dominating pain condition, severe disease preventing from participating in physical exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Muscle function	2010-2013	isometric knee-extension force (Steve Strong®)

Secondary Outcome Measures

Name	Time	Method
VAS pain	2010-2013	Pain intensity ratings on VAS
Fibromyalgia impact questionnaire	2010-2013	Ratings on FIQ, total score

Trial Locations

Locations (3)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Linkopings University Hospital; 🇸🇪 Linkoping, Sweden

Karolinska Institute; 🇸🇪 Stockholm, Sweden