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Not yet recruitingNAINTERVENTIONAL

Heat Therapy and Peripheral Artery Disease

This research study is investigating if an 8-week program of warm water soaks, known as heat therapy, can help people with Peripheral Artery Disease (PAD) who experience leg pain when walking (a symptom called intermittent claudication). Many people with PAD find walking difficult due to this pain, and the study aims to see if heat therapy can improve how far and how comfortably they can walk. Participants will either receive regular care or take part in the heat therapy program, which involves soaking in a hot tub three times a week. The study will carefully measure changes in walking ability, quality of life, and various health markers to understand if this simple therapy could offer a new way to help manage PAD symptoms. It's designed to be a safe and gentle approach.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
Manchester Metropolitan University
Enrolment target
70
Start
01 May 2025
Estimated completion
01 Jan 2028

What is this study about?

Peripheral Artery Disease (PAD) is a common condition where narrowed arteries reduce blood flow to your limbs, most commonly your legs. This often leads to leg pain when you walk, known as intermittent claudication. This pain can make everyday activities challenging and affect your quality of life.

Researchers are exploring a new, gentle approach called heat therapy to see if it can help improve symptoms for people with PAD. This study aims to find out if regularly soaking in warm water can make a difference. The idea is that warming the body might help improve blood flow and the health of blood vessels, potentially reducing pain and making it easier to walk. It's a non-drug, non-surgical approach that could be a useful addition to existing care for PAD.

The study will compare people receiving this heat therapy with those continuing their usual care. Scientists will carefully measure various aspects of health, including how far and how comfortably people can walk, their overall well-being, and specific markers related to heart and blood vessel health. The goal is to see if heat therapy is effective in improving the lives of individuals with PAD and to understand how it might work.

Key takeaways

  • Researchers are testing if warm water soaks (heat therapy) can help people with leg pain from PAD.
  • The study involves either usual care or an 8-week program of regular hot tub sessions.
  • Measurements will check improvements in walking, quality of life, and body health.
  • Participants will have health checks at the start, mid-point (8 weeks), and end (16 weeks).
  • It's a gentle approach, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult over 18 years old and have been diagnosed with a specific type of Peripheral Artery Disease (PAD) that causes leg pain when walking. You should be able to walk without help and understand English to follow instructions. It's also important that you haven't had fainting spells from heat before and, if you're a woman, you are past menopause or not using hormone therapy. You'll also need to be able to give your full permission to take part after understanding what the study involves.

There are certain reasons why someone might not be able to join. For example, if your walking problems are due to something other than PAD, or if your PAD is very severe (like having pain even at rest). If you have no symptoms from your PAD, this study might not be for you. We also can't include people who are currently being treated for cancer, have diabetes with nerve damage, or have recently or frequently used saunas or hot tubs, as this could affect the results.

Additionally, serious heart conditions such as a recent heart attack or unstable chest pain, a recent stroke, or specific valve problems would prevent participation, as these conditions might make the heat therapy unsuitable 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.

  1. Are you over 18 years old?
  2. Do you have a diagnosis of PAD that causes leg pain when you walk?
  3. Can you walk without needing help from another person?
  4. Have you ever fainted from heat before (e.g., in a hot bath or sauna)?
  5. Do you have any severe heart conditions like unstable chest pain or a recent heart attack?
  6. Are you currently undergoing cancer treatment?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be placed into one of two groups. One group will continue with their usual medical care. The other group will take part in an 8-week heat therapy program. This involves soaking in a hot tub at about 40°C three times a week. You'll start with shorter soaks, gradually working up to about 60 minutes each time over the 8 weeks.

During the study, you'll have health checks at the beginning, after 8 weeks, and again after 16 weeks. These checks will involve walking tests to measure how far you can walk without pain, answering questionnaires about your quality of life, having blood pressure taken, and providing blood samples. We'll also ask you to wear a small device (like a fitness tracker) for a week at a few different times to measure your physical activity. The total duration of your active involvement in measurements and interventions will be 16 weeks.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as a possible improvement in your walking ability and overall quality of life if the heat therapy is effective. You'll also receive careful monitoring of your health throughout the study. Potential risks are generally low, given that hot tub use is a common recreational activity, but could include feeling lightheaded or overheated, especially as the water is warm. Your safety and well-being are paramount, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Manchester Metropolitan University
    Verified postcode
    Manchester, United Kingdom

Common questions

What is Peripheral Artery Disease (PAD) and intermittent claudication?

PAD is when your leg arteries become narrowed, reducing blood flow. Intermittent claudication is the leg pain you feel when walking, which is a common symptom of PAD.

What does 'heat therapy' involve in this study?

It means soaking in a hot tub at around 40°C three times a week for 8 weeks, gradually increasing your soak time to about 60 minutes per session.

How long will the study last for me?

You will have health checks at the start, after 8 weeks, and again after 16 weeks. If you are in the heat therapy group, the intervention itself lasts 8 weeks.

Will I have to stop my usual PAD medicine?

The study does not mention changing your current medication. Always continue to take prescribed medication unless advised otherwise by your own doctor.

What if I can't finish the heat therapy sessions?

You are free to stop participating in the study at any time if you feel unwell or for any other reason. Your comfort and safety are most important.

How to find out more

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 "Heat Therapy and Peripheral Artery Disease…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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