Active not recruitingNAINTERVENTIONAL

The Effect of Physiotherapy Integrated With Yoga and Mindfulness on Individuals With Fibromyalgia

Researchers are investigating a new approach for fibromyalgia called PhYoMind. This program brings together specific physiotherapy exercises, yoga, and mindfulness practices. The aim is to see if it can help reduce pain and improve other symptoms like tiredness and sleep problems, as well as general daily function for people living with fibromyalgia. Participants will be split into two groups: one receiving the PhYoMind program and another doing a home exercise routine. The study lasts for 8 weeks, with some supervised sessions and exercises to do at home. Scientists will measure changes in how much fibromyalgia affects daily life, pain levels, stress, fatigue, and sleep quality to understand the program's effectiveness.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospital Tuebingen

Enrolment target

Start

10 Feb 2026

Estimated completion

30 May 2026

Fibromyalgia (FM)Chronic Pain

What is this study about?

Fibromyalgia is a condition that causes widespread pain, extreme tiredness, sleep issues, and other problems throughout the body. While many treatments focus on easing symptoms, they don't always get to the root cause. This study, called PhYoMind, is looking into whether combining different therapies might offer a more complete solution.

The PhYoMind program mixes special physiotherapy techniques with yoga and mindfulness. Physiotherapy helps with movement and strength, while yoga and mindfulness can help with relaxation, pain coping, and overall mental well-being. Scientists want to know if this combined approach is more effective than just doing general exercises at home.

By carefully studying participants, researchers hope to learn how PhYoMind affects not just pain and tiredness, but also things like stress, sleep, and how the body's nervous system works. This information could be really helpful in developing better ways to manage fibromyalgia in the future.

Key takeaways

Exploring a new combined therapy (PhYoMind) for fibromyalgia.
Compares PhYoMind with at-home exercises over 8 weeks.
Aims to improve pain, tiredness, sleep, and overall function.
Involves supervised sessions and home practice.
Participation includes health assessments at the start and end.
Could help shape future fibromyalgia treatment options.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of fibromyalgia from your doctor based on the American College of Rheumatology guidelines.

There are also some reasons why you might not be able to participate. For example, if you have other serious health problems that cause severe pain or make it hard to take part, or if you're already doing another physiotherapy treatment. If you regularly practice yoga or mindfulness, you won't be able to join, as the study aims to test this approach for new participants. Also, if you have certain heart conditions or uncontrolled high blood pressure, you might not be eligible.

It's important that your fibromyalgia medication or other treatments are stable and you don't plan to change them during the study. If you are pregnant or planning to become pregnant, you won't be able to take part. Also, if you have severe mental health conditions or trouble understanding instructions, this study might not be suitable.

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.

Am I at least 18 years old?
Do I have a confirmed diagnosis of fibromyalgia?
Am I NOT currently, and have I NOT recently, practiced yoga or mindfulness regularly?
Do I NOT have serious heart conditions or very high blood pressure?
Am I NOT pregnant or planning to get pregnant during the study?
Are my fibromyalgia medications stable, with no planned changes?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups. One group will do the PhYoMind program, and the other will do home exercises like stretching and strengthening. The study lasts for 8 weeks.

Throughout these 8 weeks, you will have two supervised sessions each week. You'll also be given exercises to do at home. Before the program starts (at Week 0) and immediately after it finishes (at Week 8), the research team will assess how you're doing. They'll ask about your day-to-day abilities, your pain levels, stress, tiredness, and sleep quality. They'll also check other things like how your body’s nervous system is working. Any unexpected health problems that come up during the study will be noted, as will how well you stick to the exercise plan.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as learning new ways to manage your fibromyalgia symptoms through physiotherapy, yoga, and mindfulness, or discovering new exercise routines. While generally safe, there's always a small chance of experiencing mild discomfort or muscle soreness, especially when starting new exercises. The researchers will be closely monitoring your well-being and any side effects. Remember, you can choose to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Bosch Health Campus
Verified postcode
Stuttgart, Germany

Common questions

What is PhYoMind?

PhYoMind is a new program combining specific physiotherapy exercises with yoga and mindfulness practices to help people with fibromyalgia.

How long will the study last?

The study program itself lasts for 8 weeks, with assessments at the beginning and end.

Will I have to pay to participate?

Clinical trials generally do not charge participants. This study is investigating the effectiveness of an intervention.

What if my fibromyalgia medication changes during the study?

You should be on stable medication, but any changes will be recorded. It's best to discuss this with your doctor before joining.

Can I still do my usual doctor visits if I join?

Yes, joining the study won't stop you from having your regular appointments and treatments for fibromyalgia or other conditions.