The Effects of Training and Relaxation on Fibromyalgia.
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| ClinicalTrials.gov Identifier: NCT01226784 |
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Recruitment Status :
Completed
First Posted : October 22, 2010
Last Update Posted : October 27, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fibromyalgia | Behavioral: Physcial activity | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 240 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | The Effects of Training and Relaxation on Fibromyalgia. |
| Actual Study Start Date : | October 2010 |
| Actual Primary Completion Date : | May 2015 |
| Actual Study Completion Date : | October 2020 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Physcial exercise
15 weeks of progressive resistance group exercise, twice/week supervised by physical therapist
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Behavioral: Physcial activity
Strenght training Relaxation exercise |
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Active Comparator: Relaxation exercise
15 weeks of relaxation exercise, twice/week supervised by physical therapist
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Behavioral: Physcial activity
Strenght training Relaxation exercise |
- Muscle function [ Time Frame: 2010-2013 ]isometric knee-extension force (Steve Strong®)
- Fibromyalgia impact questionnaire [ Time Frame: 2010-2013 ]Ratings on FIQ, total score
- VAS pain [ Time Frame: 2010-2013 ]Pain intensity ratings on VAS
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| Ages Eligible for Study: | 20 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria: ACR 1990 criteria for fibromyalgia -
Exclusion Criteria: Other dominating pain condition, severe disease preventing from participating in physical exercise
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226784
| Sweden | |
| Sahlgrenska University Hospital | |
| Gothenburg, Sweden, 41 345 | |
| Linkopings University Hospital | |
| Linkoping, Sweden, 581 85 | |
| Karolinska Institute | |
| Stockholm, Sweden, 171 77 | |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eva Kosek, Professor, Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT01226784 |
| Other Study ID Numbers: |
RF 2010 stud GLS |
| First Posted: | October 22, 2010 Key Record Dates |
| Last Update Posted: | October 27, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Strength exercise Physical exercise Physiotheraphy |
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Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |

