RecruitingNAINTERVENTIONAL

Intradialytic Exercise With Blood Flow Restriction in Hemodialysis Patients

This study is investigating if exercising during dialysis, either with or without a special cuff that gently restricts blood flow, can help protect and strengthen the hearts of people undergoing dialysis. They will compare two types of exercise programs against standard dialysis with no exercise. The aim is to see if exercising during treatment can reduce heart stress and improve heart health over time. Researchers also want to find out if combining exercise with blood flow restriction makes these benefits even greater. They'll look at both the immediate effects of a single exercise session and the longer-term benefits of a regular program. Your participation would help us understand better ways to improve heart health for dialysis patients.

At a glance

Status

Recruiting

Phase

Sponsor

University of Avignon

Enrolment target

108

Start

06 Nov 2025

Estimated completion

06 Oct 2028

Dialysis Patients

What is this study about?

Imagine your heart working hard during dialysis. This study, called "Intradialytic Exercise With Blood Flow Restriction in Hemodialysis Patients," wants to see if adding some simple exercises during your dialysis treatment can help your heart stay healthier and stronger. We know that dialysis can put a strain on your heart, and sometimes it can lead to what doctors call 'myocardial stunning,' which is like your heart muscle becoming temporarily tired or 'stunned' during treatment. We're also interested in 'cardiac remodelling,' which refers to how your heart might change its shape or function over time due to various factors, including dialysis.

In this study, we're testing two different exercise programs. One involves exercising while you're on dialysis, and the other is the same exercise but with a special cuff on your arm or leg gently restricting blood flow – this is called 'blood flow restriction' (BFR). The idea behind BFR is that it might make the exercise more effective at a lower intensity. We're comparing both of these exercise approaches to a group who will continue with their usual dialysis treatment without any extra exercise. We want to find out if these exercises, especially with BFR, can reduce that heart 'stunning' and make your heart stronger and function better in the long run.

This research is important because if we can find safe and effective ways to help your heart during dialysis, it could make a big difference to your overall health and well-being. We're looking at things like whether your heart gets less stressed during dialysis, if its shape and function improve, and even whether your muscles get stronger. By joining, you'd be helping us learn how to provide better care for people like you who are on dialysis.

Key takeaways

This study explores how exercise during dialysis can help your heart.
It compares exercise with and without gentle blood flow restriction against standard dialysis.
The goal is to reduce heart stress and improve heart health for dialysis patients.
Participation involves special exercises during some dialysis sessions.
Your health will be closely monitored throughout the study.

Who may be eligible?

To join this study, you need to be between 20 and 79 years old and have been on dialysis for at least three months. It's important that you don't already exercise regularly outside of dialysis, and you haven't done any exercise during dialysis in the last six months. You also need to be generally fit enough for some physical activity, with your doctor's okay, and expected to live for more than six months. Good 'echogenicity' means we can get clear images of your heart during tests.

There are some reasons why you wouldn't be able to join. For example, if you're already in another medical study or have been in one very recently. We also can't include people who are pregnant, breastfeeding, or under legal protection preventing them from giving informed consent. If you have certain heart conditions like unstable chest pain (angina), severe peripheral artery disease, or problems with your muscles or bones that make exercise difficult, this study might not be suitable for you.

Other reasons to not be eligible include having a pacemaker or certain other heart devices, a history of heart transplant, uncontrolled high blood pressure, or a type of anaemia that isn't responding to treatment. We also can't include individuals at high risk for blood clots in their legs. These rules are in place to make sure the study is safe for everyone involved.

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 between 20 and 79 years old?
Have you been on dialysis for more than 3 months?
Do you currently NOT regularly exercise outside of dialysis?
Have you NOT done exercise during dialysis in the last 6 months?
Does your doctor agree you are generally fit enough for light exercise?
Do you NOT have serious heart issues like unstable angina or an implanted heart device?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned to one of three groups by chance, like drawing straws. One group will do exercise with blood flow restriction during dialysis, another will do exercise without blood flow restriction, and the third will continue with their usual dialysis without any extra exercise. Before you start the main part of the study, everyone will try out one session of each of the three types of dialysis (standard, exercise, exercise with BFR) in a random order to see the immediate effects.

The main part of the study will involve following your assigned program during your regular dialysis sessions for a certain period. We will regularly check your heart function using special scans and monitor your physical fitness and muscle strength. You won't need to take any new medication for this study. The total duration of your participation will include these initial 'acute effect' sessions and then the longer 'chronic phase' based on your assigned group, but the exact total duration will be clearly explained to you before you agree to take part. All tests and assessments will be explained in detail.

Potential risks and benefits

Participating in this study might offer potential benefits, such as improved heart health, stronger muscles, and better aerobic fitness, especially if you are in one of the exercise groups. However, there's no guarantee you will experience these benefits. Potential risks include discomfort or minor muscle soreness from the exercise, and with blood flow restriction, there might be temporary numbness, tingling, or bruising, though these are usually mild. Your health will be closely monitored by medical professionals throughout the study. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

CHU Strasbourg
Verified postcode
Strasbourg, France· Not yet recruiting
Medipole Lyon
Verified postcode
Villeurbanne, France· Recruiting

Common questions

What is 'blood flow restriction' and is it safe?

Blood flow restriction uses a special cuff, like a blood pressure cuff, to gently restrict blood flow to your arm or leg during exercise. It's generally considered safe when properly supervised, making exercise more effective at a lower intensity.

Will I have to exercise during every dialysis session?

If you're in an exercise group, you'll be doing exercises during your dialysis sessions according to the study plan. The other group will have standard dialysis without exercise.

What kind of exercises will I be doing?

The exercises will be tailored to be safe and suitable for you to do while on dialysis. They will likely involve light movements to improve muscle strength and fitness.

How long will I be in the study?

The study involves an initial phase where you try different approaches, followed by a longer 'chronic' phase depending on which group you're assigned to. The full duration will be explained to you.

Will I know which group I'm in?

Yes, once you've completed the initial 'acute' phase trials, you will be told which of the three main study groups you have been randomly assigned to for the longer-term part of the study.

How to find out more

Philippe Obert, PhD

philippe.obert@univ-avignon.fr 0033698050446 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.