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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
| Västra Götalands Forskningsfond | UNKNOWN |
| Reumatikerförbundet | UNKNOWN |
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The study aims to compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A. High intensive exercise | Experimental | High intensive exercise |
|
| B. Low-intensive exercise | Active Comparator | Low-to-moderate intensive supervised walks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical exercise | Behavioral | Supervised walks with poles twice a week at moderate-high intensity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Six-minute Walk Test | Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented. | 15 weeks |
| Change of Pain Level From Baseline. | 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. | 15 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kaisa E Mannerkorpi, Ass prof | Göteborg University, Dept of Rheumatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alingsås Primary Health Care | Alingsås | Sweden | ||||
| Sahlgrenska University Hospital, Dept of Physical Therapy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23446104 | Derived | Bjersing JL, Erlandsson M, Bokarewa MI, Mannerkorpi K. Exercise and obesity in fibromyalgia: beneficial roles of IGF-1 and resistin? Arthritis Res Ther. 2013 Feb 27;15(1):R34. doi: 10.1186/ar4187. | |
| 22776095 | Derived | Bjersing JL, Dehlin M, Erlandsson M, Bokarewa MI, Mannerkorpi K. Changes in pain and insulin-like growth factor 1 in fibromyalgia during exercise: the involvement of cerebrospinal inflammatory factors and neuropeptides. Arthritis Res Ther. 2012 Jul 9;14(4):R162. doi: 10.1186/ar3902. |
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| ID | Title | Description |
|---|---|---|
| FG000 | A. High Intensive Exercise | High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks |
| FG001 | B. Low-intensive Exercise | Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A. High Intensive Exercise | High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks |
| BG001 | B. Low-intensive Exercise | Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Six-minute Walk Test | Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented. | Posted | Mean | Standard Deviation | meter | 15 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A. High Intensive Exercise | High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. K Mannerkorpi | Gothenburg University | 046-31-24220 | kaisa.mannerkorpi@rheuma.gu.se |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D005356 | Fibromyalgia |
| D009043 | Motor Activity |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Active comparator: low intensive exercise | Behavioral | Supervised walks once a week at low-intensity. |
|
| Gothenburg |
| 41345 |
| Sweden |
| Uddevalla Primary Health Care | Uddevalla | Sweden |
| 20942911 | Derived | Mannerkorpi K, Nordeman L, Cider A, Jonsson G. Does moderate-to-high intensity Nordic walking improve functional capacity and pain in fibromyalgia? A prospective randomized controlled trial. Arthritis Res Ther. 2010;12(5):R189. doi: 10.1186/ar3159. Epub 2010 Oct 13. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Change of Pain Level From Baseline. | 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. | Patients attending at post-test | Posted | Mean | Standard Deviation | mm | 15 weeks |
|
|
|
| 0 |
| 33 |
| 0 |
| 34 |
| EG001 | B. Low-intensive Exercise | Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks | 0 | 33 | 0 | 33 |
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| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D001519 | Behavior |
| D010335 | Pathologic Processes |