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| ID | Type | Description | Link |
|---|---|---|---|
| University of Tromso | Other Identifier | University of Tromso |
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| Name | Class |
|---|---|
| University Hospital of North Norway | OTHER |
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The goal of this clinical trial is to learn if the combination of two interventions is more effective in treating fibromyalgia symptoms than one intervention alone. The participant group will be people with fibromyalgia in age group 18-65 years. The two interventions to be tested over sixteen weeks are:
The main question it aims to answer is: Is the combination of group exercising and somatic tracking work more efficient than physical activity alone in terms of managing fibromyalgia?
Participants will wear Fitbit activity trackers, register pain intensity daily on a mobile app, and answer the Fibromyalgia Impact Questionnaire (FIQ). They will be divided into four groups:
Before the sixteen weeks intervention period, there will be a baseline period of eight weeks. Durng the baseline period, participants will wear activity trackers and maintain their usual lifestyle.
Researchers will compare the combination of the interventions against only one intervention and the control group.
Fibromyalgia is a chronic condition characterised by musculoskeletal pain, fatigue, poor sleep and an overall reduced quality of life. It is well known that physical activity improves symtpons of fibromyalgia, although not all people affected by the condition have positive experiences from exercising. People with fibromyalgia have also stated that physical activity alone is not enough for managing symptomes effectively. This is the background for the proposed randomized controlled trial with a 2*2 factorial design, where two interventions are tested, alone and in combination.
There will be a baseline period of 8 weeks and an intervention period of 16 weeks.
Evaluations will occur at the end of the baseline period (8 weeks) and at the end of the intervention period (24 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group exercising | Experimental | Receives weekly supervised group exercise sessions, a wrist-worn activity tracker, and access to national recommendations on physical activity. |
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| Somatic tracking | Experimental | Receives weekly sessions of somatic tracking by a certified therapist, a wrist-worn activity tracker, and access to national recommendations on physical activity. |
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| Group exercising and somatic tracking | Experimental | Receives weekly group exercise sessions, weekly somatic tracking sessions, a wrist-worn activity tracker, and access to national recommendations on physical activity. |
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| Control group | Active Comparator | Receives a wrist-worn activity tracker and access to national recommendations on physical activity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group exercising | Other | Weekly, supervised exercise sessions in groups |
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| Measure | Description | Time Frame |
|---|---|---|
| Total FIQ score | Fibromyalgia Impact Questionnaire (FIQ) is widely used in clinical trials in fibromyalgia patients. The questionnaire contains questions that are answered using a scale. The scores from each question are used to calculate a total FIQ score. | At end of baseline (8 weeks) and post-intervention (24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Steps per day | Measured by Fitbit activity trackers | 24 weeks |
| Resting heart rate | Measured by Fitbit | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johan Gustav Bellika | Contact | +4795748049 | Johan.Gustav.Bellika@ehealthresearch.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tromsø | Tromsø | Troms | 9019 | Norway |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D009043 | Motor Activity |
| D010146 | Pain |
| D059352 | Musculoskeletal Pain |
| D012216 | Rheumatic Diseases |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D001519 | Behavior |
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The trial applies a 2*2 factorial design.
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| Somatic tracking | Other | A psychological intervention aiming to learn the brain to reinterpret pain signals. |
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| General activity recommendaitons | Other | General recommendaitons for physical activity and healthy lifestyle |
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| Insomnia Severity Index (ISI) | ISI is calculated from a questionnaire containing sleep and insomnia related questions | At end of baseline (8 weeks) and post-intervention (24 weeks) |
| Self-reported pain intensity | Self-reported pain intensity measured by Visual Analogue Scale (VAS). Participants will be asked to register their pain intensity once daily through a mobile application. | 24 weeks |
| Minutes lightly active | Measured by Fitbit | 24 weeks |
| Minutes moderately active | Measured by Fitbit | 24 weeks |
| Minutes very active | Measured by Fitbit | 24 weeks |
| Sleep efficiency | Measured by Fitbit. The formula for sleep efficiency is time asleep/(total time in bed - time to fall asleep) | 24 weeks |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |