FibromyalgiaFIBROQUALLIFENCT02482714
Life Quality Determinant Assessment of Fibromyalgia Patients
A study testing Physical activity. in people with Fibromyalgia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The primary purpose is the evaluation of life quality of Fibromyalgia patients. The investigators' main hypothesis includes the role of geographical, sociological, psychological and physical activity on life quality. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Physical activity.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to 12 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group : 20 to 60
- Male or female
- American College of Rheumatology criteria
- Social Security beneficiary
- Informed consent of the patient
- Patient informed of the medical examination prior to inclusion
- Patient residing in the Bas-Rhin area
Who cannot join
- No medical objections to performing a stress test
- Any cardio-respiratory and musculoskeletal affection preventing physical activity
- Any particular clinical form disease
- Patient in situation of exclusion
- Subject incapacity to understand informed consent
- Patient deprived of freedom or under the protection of a conservator
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Life Quality Determinant Assessment of Fibromyalgia Patients Related to Health Devices
The primary purpose is the evaluation of life quality of Fibromyalgia patients. The investigators' main hypothesis includes the role of geographical, sociological, psychological and physical activity on life quality.
- Conditions
- Fibromyalgia
- Being tested
- Physical activity.
- Keywords
- Quality of Life, Physical Activity
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity.Behavioural
Have subject do moderate physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Rehab Institute | Experimental | This group will do some physical activity in a specialized institute Receives: Behavioral: Physical activity. |
| Club structure | Active comparator | This group will do some physical activity in a club. Receives: Behavioral: Physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life with Fibromyalgia score on questionnary QIF (Quality of Life with Fibromyalgia)
Measured: 6th month
Secondary outcomes (2)
Score on questionnary Short Form (36) SF36
Measured: 6th month
Measurement of displacement with Global Positioning System GPS
Measured: 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startSep 2015
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Why it stopped: recruitment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jehan Lecocq, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482714
- Sponsor's protocol ID
- 6118
- Acronym
- FIBROQUALLIFE
- Status last verified
- Aug 2021
- First submitted
- 18 Jun 2015
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life Quality Determinant Assessment of Fibromyalgia Patients Related to Health Devices
- ClinicalTrials.gov ID
- NCT02482714
- Acronym / sponsor ID
- FIBROQUALLIFE / 6118
- Conditions
- Fibromyalgia
- Keywords
- Quality of Life, Physical Activity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulty
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose is the evaluation of life quality of Fibromyalgia patients. The investigators' main hypothesis includes the role of geographical, sociological, psychological and physical activity on life quality.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehab Institute | Experimental | Behavioral: Physical activity.This group will do some physical activity in a specialized institute |
| Club structure | Active comparator | Behavioral: Physical activity.This group will do some physical activity in a club. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age group : 20 to 60
- Male or female
- American College of Rheumatology criteria
- Social Security beneficiary
- Informed consent of the patient
Key exclusion criteria (7 listed)
- No medical objections to performing a stress test
- Any cardio-respiratory and musculoskeletal affection preventing physical activity
- Any particular clinical form disease
- Patient in situation of exclusion
- Subject incapacity to understand informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity.Have subject do moderate physical activity. | Behavioural | Club structure, Rehab Institute |
Primary outcome
Quality of Life with Fibromyalgia score on questionnary QIF (Quality of Life with Fibromyalgia)
Time frame: 6th month
2 secondary outcomes
Score on questionnary Short Form (36) SF36
Time frame: 6th month
Measurement of displacement with Global Positioning System GPS
Time frame: 6th month
Results and safety
The study was stopped early (reason given: recruitment difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jehan Lecocq, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity. in people with Fibromyalgia, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment difficulty). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life with Fibromyalgia score on questionnary QIF (Quality of Life with Fibromyalgia) (time frame: 6th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.