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RecruitingNAINTERVENTIONAL

APA and Relaxation by Biofeedback in Patients With Haematological Malignancy Admitted in ICU

This study is for people with blood cancer who are in intensive care. We want to see how different types of exercise and relaxation can help reduce feelings of worry and anxiety. Being in intensive care with a serious illness can be very stressful and can make people feel tired or weak. We're testing three approaches: regular supervised exercise, exercise using fun video games (Exergaming), and exercise combined with a special relaxation technique called biofeedback. Biofeedback helps you learn to control your body's reactions, like your breathing or heart rate, to feel calmer. The main goal is to find out if these exercise and relaxation methods can make a real difference to how anxious people feel and to help them keep up their strength.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Centre Hospitalier Régional Metz-Thionville
Enrolment target
90
Start
02 Dec 2022
Estimated completion
01 Jan 2027

What is this study about?

When people have serious blood cancers, especially when they need to be in intensive care, it can be a really tough time. Not only are they coping with their illness, but they might also feel very tired, weak, and worried. Being in a hospital, sometimes alone in a special room, can naturally make anxiety and even sadness worse. This can make it harder for people to do everyday things for themselves and can affect their overall quality of life.

Doctors and nurses are increasingly looking at ways to support patients beyond just medical treatments. This study is exploring how 'adapted physical activity' (which just means exercise tailored to your needs) and relaxation techniques can help. Regular, gentle exercise has been shown to boost both physical strength and mental well-being. It can help maintain muscle strength and fitness that might otherwise be lost when you're unwell and spending a lot of time in bed. Exercise can also help you feel better emotionally, boosting confidence and a sense of achievement. Relaxation techniques are also very good at calming worries.

This research wants to see if combining exercise with other supportive tools can be even more helpful. We're testing three different approaches: a standard exercise programme, exercising using special fun video games (called Exergaming), and exercise combined with something called biofeedback relaxation. Exergaming makes exercise more enjoyable and motivating. Biofeedback is a clever technique where a device helps you become more aware of your body's signals, like your breathing or heart rate. By seeing these signals, you can learn to control them, which can help you relax more deeply. The study aims to find out if these methods can reduce anxiety and help people maintain their strength and independence.

Key takeaways

  • The study explores exercise and relaxation for blood cancer patients in ICU.
  • It aims to reduce anxiety and maintain physical strength.
  • Different methods include regular exercise, 'Exergaming' (exercise with video games), and 'biofeedback relaxation'.
  • Participation is supervised and adapted to individual health needs.
  • You can stop participating at any time without affecting your care.

Who may be eligible?

To be considered for this study, you would need to be between 18 and 75 years old and currently receiving care in an Intensive Care Unit (ICU).

You wouldn't be able to join if you have a medical condition that makes physical exercise unsafe for you. Also, if you can't understand French, either spoken or written, this study might not be suitable as the materials are in French. Finally, if you're already involved in another clinical research study, or if you don't have health insurance, you wouldn't be able to take part.

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.

  1. Are you between 18 and 75 years old?
  2. Are you currently cared for in an Intensive Care Unit (ICU)?
  3. Are you able to safely do some gentle physical activity (your doctor can advise on this)?
  4. Can you understand explanations given in French (both spoken and written)?
  5. Are you not currently taking part in another research study?
Answer every question to see your result.

What does participation involve?

If you join this study, you would take part in a supervised exercise and/or relaxation programme while you are in the Intensive Care Unit. This could involve gentle movements, using special video games for exercise, or learning relaxation techniques with a biofeedback device. The specific activities and how often they happen would depend on which group you are in and your own health. Throughout the study, we would regularly check how you are feeling and measure your anxiety levels, as well as looking at your physical abilities. The total duration of your participation would depend on how long you remain in intensive care. Specific details about the frequency and length of sessions would be explained to you thoroughly.

Potential risks and benefits

Taking part in any study has potential benefits and risks. Potential benefits might include feeling less anxious, improving your physical strength faster, and feeling more in control during a difficult time. The exercise programmes are designed to be adapted to your condition to minimise risks, but like any physical activity, there's always a very small chance of minor discomfort or strain. The relaxation techniques are generally very safe. You would be closely monitored by healthcare professionals at all times. Remember, 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 (1)

  • CHR Metz-Thionville/Hopital de Mercy
    Verified postcode
    Metz, France· Recruiting

Common questions

What is 'biofeedback relaxation'?

It's a way to learn to control your body's stress responses. A device shows you things like your breathing or heart rate, and you learn to change them to feel calmer.

What is 'Exergaming'?

It's exercise that feels like playing a video game. It makes being active more fun while you're in hospital.

Will I have to do difficult exercises?

No, all activities will be gentle and carefully adapted to what your body can safely do, with supervision from a healthcare professional.

Can I stop participating if I don't like it?

Yes, you can choose to leave the study at any time, and it won't affect your medical care.

Why is this study important?

It helps us find better ways to support people's emotional and physical well-being when they are seriously ill with blood cancer in intensive care.

How to find out more

Arpiné EL NAR, PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "APA and Relaxation by Biofeedback in Patients With Haematolo…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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