Efficiency of an Optimized Care Organization for Fibromyalgia Patients Within the Group of Hospitals of Loire Territory. Interventional Study Aimed at Changing Behaviour in Terms of Physical Activity and Sedentary
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 330
- Locations
- 14
- Primary Endpoint
- physical activity
Study Overview
Brief Summary
Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest.
The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest.
Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.
Detailed Description
In order to set up an optimal patient path within the Group of hospitals of Loire territory, the working group composed of doctors from different specialities of the department considered it important to carry out a randomised study evaluating the effectiveness of a healthcare organisation combining:
- an adapted and supervised physical activity intervention (1 month hospital initiation then 2 months in town)
- therapeutic education sessions for the patient with motivational interviews Compared to usual clinical practice (adapted physical activity adapted in autonomy at home + therapeutic patient education sessions with motivational interviews).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient diagnosed with fibromyalgia according to ACR (American College of rheumatology) criteria (total score WPI (Widespread Pain Index) + SS (Severity Scale) ) ≥ 13
- •French writing and speaking
- •Sedentary or low level of activity (less than 150 minutes of regular physical activity per week at the time of inclusion)
- •Signature of informed consent
Exclusion Criteria
- •Cardiac or respiratory diseases that contraindicate the practice of physical activity
- •Significant co-morbidities that contraindicate the practice of physical activity: associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies (severe obstructive or severe respiratory insufficiency), disabling joint pathologies (knee osteoarthritis or osteoarthritis of the hip) training on a treadmill or on a high intensity bike).
- •Impossibility of submitting to the medical monitoring of the program for geographical, social or psychological reason
Arms & Interventions
fibromyalgia patients with physical activity program
Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified "Sports Health" in the Loire (42) or Haute-Loire (43) for 2 months.
Intervention: physical activity program (Other)
fibromyalgia patients with physical activity at home
Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).
Intervention: Advice and recommendations of physical activity at home (Other)
Outcomes
Primary Outcomes
physical activity
Time Frame: 12 months
Measure the durability of adherence/therapeutic compliance of fibromyalgia patients based on an objective measurement of physical activity: average measured from 7 days of actimetry, Actigraph
Secondary Outcomes
- muscular endurance(0, 1 and 3 months)
- Direct non-medical costs(12 and 24 months)
- gas exchange measurement(0, 1 and 3 months)
- Cost of lost productivity(12 and 24 months)
- sedentary(0, 1, 3, 6, 12 and 24 months)
- physical activity(0, 1, 3, 6, 12 and 24 months)
- Anxiety and Depression(0, 1, 3, 6, 12 and 24 months)
- pain catastrophizing(0, 1, 3, 6, 12 and 24 months)
- pain evaluation(6 and 12 months)
- muscle power(0, 1 and 3 months)
- Direct medical costs(12 months)
- fatigue evaluation(6 and 12 months)
- health status(0, 1, 3, 6, 12 and 24 months)
- fatigue(0, 1 and 3 months)
- Quality of sleep(0, 1, 3, 6, 12 and 24 months)
- sedentary times in hours/day(0, 1, 3, 6, 12 and 24 months)
- quantification of physical activity in meter-h/week(0, 1, 3, 6,12 and 24 months)
- patient adherence(6 and 12 months)