Active not recruitingNAINTERVENTIONAL

Efficiency of an Optimized Care Organization for Fibromyalgia Patients. The FIMOUV 2 Study

This study, called FIMOUV 2, aims to find the most effective way for people with fibromyalgia to manage their condition through physical activity. Fibromyalgia causes ongoing tiredness and pain, affecting about 2 to 5 out of every 100 adults. Often, people with fibromyalgia become less active, which can worsen their symptoms. Doctors already know that exercise is helpful. This study wants to see two types of support: either getting simple advice on how to exercise regularly at home, or joining a more structured, supervised exercise program that starts in the hospital and continues in the community. The goal is to discover if extra support and supervision lead to better results for patients.

At a glance

Status

Active not recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrolment target

330

Start

23 Jan 2020

Estimated completion

01 Oct 2031

Fibromyalgia Physical Activity

What is this study about?

You might have heard of or experienced fibromyalgia, a condition that causes ongoing pain all over the body, along with extreme tiredness that doesn't get better with rest. It can also lead to issues like problems sleeping and difficulty thinking clearly. These symptoms can make it hard to stay active, and for many people, reduced activity can unfortunately make their fibromyalgia symptoms worse over time.

Doctors and experts agree that keeping active is a really important way to help manage fibromyalgia, often more effective than just relying on medicines. We know that exercise can reduce pain and improve your overall well-being. However, there's a big question: is it enough to just be told to exercise more, or would having more hands-on help and supervision make a bigger difference?

This study, FIMOUV 2, has been set up by a team of doctors to explore this very question. They want to compare two ways of helping people with fibromyalgia get more active. One group will get general advice on how to exercise on their own at home, along with some educational sessions. The other group will take part in a special, supervised exercise program that starts in the hospital for a month and then continues in the community for two more months. This group will also have educational sessions and motivational discussions. By comparing these two approaches, the researchers hope to find the best way to support people with fibromyalgia in becoming more active and feeling better.

Key takeaways

The study explores the best way to help people with fibromyalgia get active.
It compares simple exercise advice with a supervised exercise program.
Physical activity is known to help manage fibromyalgia symptoms like pain and fatigue.
Participation involves either home-based exercise or a supervised program for 3 months.
The study aims to improve care for people living with ongoing pain and tiredness.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) who has been diagnosed with fibromyalgia by a doctor, specifically based on certain criteria used by the American College of Rheumatology. You also need to be able to speak and write in French. Importantly, you should not be very active already; this study is looking for people who currently do less than 150 minutes of regular physical activity per week.

There are also some reasons why you might not be able to join. For example, if you have certain heart or breathing problems that would make exercising unsafe, or if you have severe joint conditions (like very bad arthritis in your knees or hips) that would prevent you from using equipment like treadmills or exercise bikes, you wouldn't be able to participate. Also, if there are reasons like your location, social situation, or personal health (psychological issues) that would make it impossible for you to attend all the study appointments, then this study might not be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with fibromyalgia by a doctor?
Do you generally do less than 2 and a half hours of physical activity per week?
Do you speak and write in French?
Do you have any serious heart, lung, or joint problems that make exercise unsafe?
Are you able to attend appointments for the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you would first have a medical assessment. You would then be put into one of two groups by chance – like flipping a coin. One group would receive advice on how to do physical activity at home and have a check-up at 3 months. The other group would start with a month-long supervised physical activity program in the hospital, followed by two months of supervised activity in your local community. Both groups would also have sessions that teach you about your condition and help you stay motivated.

The total duration of the active part of the study is 3 months, with a medical assessment to see how you're doing. You wouldn't be given specific medication as part of the study, as it focuses on physical activity.

Potential risks and benefits

Taking part in this study could potentially help you manage your fibromyalgia symptoms better, especially your pain and tiredness, by finding a physical activity program that works for you. You might also gain knowledge and motivation to stay active. As with any exercise, there's a small risk of muscle soreness or injury, but the supervised program is designed to be safe and adapted to your needs. You can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

CH d'ANNONAY
Verified postcode
Annonay, France
CH de Firminy
Verified postcode
Firminy, France
CH de MONTBRISON
Verified postcode
Montbrison, France
CH de Rive de Gier
Verified postcode
Rive-de-Gier, France
CH de ROANNE
Verified postcode
Roanne, France
CH du Gier
Verified postcode
Saint-Chamond, France
Chu Saint Etienne
Verified postcode
Saint-Etienne, France

Common questions

What is fibromyalgia?

Fibromyalgia is a long-term condition that causes widespread body pain, extreme tiredness, sleep problems, and sometimes difficulty concentrating.

Why is exercise important for fibromyalgia?

Regular physical activity can help reduce pain and tiredness, improve sleep and mood, and generally make you feel better when you have fibromyalgia.

Will I have to take any new medicines in this study?

No, this study is focused on physical activity and how it helps with fibromyalgia, not on new medications.

How long will the study last?

The main part of the exercise program and monitoring will last for about 3 months.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any point, and your decision won't affect your regular medical care.