search
Back to results

Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. (FIMOUV 1)

Primary Purpose

Fibromyalgia, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
physical activity program
Advice and recommendations of physical activity at home
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fibromyalgia focused on measuring sedentary time

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient lived in t Loire (42) or Haute-Loire (43)
  • 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 2 hours 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

Sites / Locations

  • Chu Saint Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

fibromyalgia patients with physical activity program

fibromyalgia patients with physical activity at home

Arm Description

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.

Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).

Outcomes

Primary Outcome Measures

Assessment of the impact of a 3-month program
Health status assessed by the PGIC = Patient Global Impression of Change. interpretation : 0= no change, 7= clear improvement, 5= better).

Secondary Outcome Measures

fatigue
assessed by Fatigue Severity Scale. This is a short questionnaire of 9 questions to which the patient answers on a scale from 1 to 7. Simply add the scores and divide by 9 - you get a result on 7 points. The higher the result, the greater the fatigue. Several studies speak of a threshold at 5.5
Quality of sleep
assessed by the Pittsburgh. The questionnaire includes 19 self-assessment questions and 5 questions for the spouse or roommate (if any). Only self-assessment questions are included in the score. The 19 self-assessment questions combine to give 7 components" of the score with each component receiving a score of 0 to 3. In all cases, a score of 0 indicates that there is no difficulty while a score of 3 indicates the existence of severe difficulties. The 7 components of the score add up to give an overall score from 0 to 21 points, 0 meaning that there is no difficulty, and 21 indicating on the contrary major difficulties.
Anxiety and Depression
assessed by the Hospital Anxiety and Depression Scale (HADS) : An overall score of 19 or more indicates a major depressive episode. An overall score of 13 corresponds to adjustment disorders and minor depression.
pain catastrophizing
assessed by the PCS (pain catastrophizing scale) assessing catastrophism : there are thirteen statements describing different thoughts and emotions that may be associated with pain. the person must indicate how painful these thoughts and emotions are. From 0= not at all to 4 = all the time
pain evaluation
assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)
muscle power
evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.
muscular endurance
evaluated by dynamometry on a stress platform (arms and legs).
gas exchange measurement
evaluated during a stress test
quantification of physical activity in meter-h/week
evaluated by the APAQ : Adult Physical Activity Questionnaire
sedentary times in hours/day
evaluated by the APAQ : Adult Physical Activity Questionnaire
daily energy expenditure
evaluated by actimetry
time of physical activity
evaluated by actimetry
physical inactivity
evaluated by actimetry
patient adherence
number of sessions performed
Direct medical costs
consultations, examinations, hospitalizations in euros
Direct non-medical costs
transport
Cost of lost productivity
time not worked

Full Information

First Posted
November 5, 2018
Last Updated
September 28, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
search

1. Study Identification

Unique Protocol Identification Number
NCT03736733
Brief Title
Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study.
Acronym
FIMOUV 1
Official Title
Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. Interventional, Controlled, Randomized, Open Study of an Original Outpatient Management.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
December 19, 2019 (Actual)
Study Completion Date
June 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Physical Activity
Keywords
sedentary time

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fibromyalgia patients with physical activity program
Arm Type
Experimental
Arm Description
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.
Arm Title
fibromyalgia patients with physical activity at home
Arm Type
Other
Arm Description
Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).
Intervention Type
Other
Intervention Name(s)
physical activity program
Intervention Description
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 Type
Other
Intervention Name(s)
Advice and recommendations of physical activity at home
Intervention Description
Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).
Primary Outcome Measure Information:
Title
Assessment of the impact of a 3-month program
Description
Health status assessed by the PGIC = Patient Global Impression of Change. interpretation : 0= no change, 7= clear improvement, 5= better).
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
fatigue
Description
assessed by Fatigue Severity Scale. This is a short questionnaire of 9 questions to which the patient answers on a scale from 1 to 7. Simply add the scores and divide by 9 - you get a result on 7 points. The higher the result, the greater the fatigue. Several studies speak of a threshold at 5.5
Time Frame
at 3 months
Title
Quality of sleep
Description
assessed by the Pittsburgh. The questionnaire includes 19 self-assessment questions and 5 questions for the spouse or roommate (if any). Only self-assessment questions are included in the score. The 19 self-assessment questions combine to give 7 components" of the score with each component receiving a score of 0 to 3. In all cases, a score of 0 indicates that there is no difficulty while a score of 3 indicates the existence of severe difficulties. The 7 components of the score add up to give an overall score from 0 to 21 points, 0 meaning that there is no difficulty, and 21 indicating on the contrary major difficulties.
Time Frame
at 3 months
Title
Anxiety and Depression
Description
assessed by the Hospital Anxiety and Depression Scale (HADS) : An overall score of 19 or more indicates a major depressive episode. An overall score of 13 corresponds to adjustment disorders and minor depression.
Time Frame
at 3 months
Title
pain catastrophizing
Description
assessed by the PCS (pain catastrophizing scale) assessing catastrophism : there are thirteen statements describing different thoughts and emotions that may be associated with pain. the person must indicate how painful these thoughts and emotions are. From 0= not at all to 4 = all the time
Time Frame
at 3 months
Title
pain evaluation
Description
assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)
Time Frame
at 3 months
Title
muscle power
Description
evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.
Time Frame
at 3 months
Title
muscular endurance
Description
evaluated by dynamometry on a stress platform (arms and legs).
Time Frame
at 3 months
Title
gas exchange measurement
Description
evaluated during a stress test
Time Frame
at 3 months
Title
quantification of physical activity in meter-h/week
Description
evaluated by the APAQ : Adult Physical Activity Questionnaire
Time Frame
at 3 months
Title
sedentary times in hours/day
Description
evaluated by the APAQ : Adult Physical Activity Questionnaire
Time Frame
at 3 months
Title
daily energy expenditure
Description
evaluated by actimetry
Time Frame
at 3 months
Title
time of physical activity
Description
evaluated by actimetry
Time Frame
at 3 months
Title
physical inactivity
Description
evaluated by actimetry
Time Frame
at 3 months
Title
patient adherence
Description
number of sessions performed
Time Frame
at 3, 6 and 12 months
Title
Direct medical costs
Description
consultations, examinations, hospitalizations in euros
Time Frame
at 3, 6 and 12 months
Title
Direct non-medical costs
Description
transport
Time Frame
at 3, 6 and 12 months
Title
Cost of lost productivity
Description
time not worked
Time Frame
at 3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient lived in t Loire (42) or Haute-Loire (43) 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 2 hours 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David HUPIN, MD
Organizational Affiliation
CHU de Saint Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study.

We'll reach out to this number within 24 hrs