Home-based HIIT in a Primary-care Setting for at Risk Individuals: A Multidisciplinary Approach (NCT04553614) | Clinical Trial Compass
CompletedNot Applicable
Home-based HIIT in a Primary-care Setting for at Risk Individuals: A Multidisciplinary Approach
United Kingdom154 participantsStarted 2017-10-10
Plain-language summary
The prevalence of chronic inactivity related diseases including obesity, insulin resistance and type 2 diabetes mellitus has reached global epidemic proportions. Exercise training is a clinically proven primary intervention that delays and in many cases prevents health burdens. Therefore, many health authorities and local councils run exercise referral schemes for individuals with elevated disease disk. However, a number of barriers to successful completion of traditional exercise referral schemes exist.
This study aims to investigate the use of a home-based high intensity interval training programme as a potential exercise referral scheme activity to overcome many of the barriers to successful exercise referral scheme adherence and uptake.
200 people referred to the Active Sefton (Sefton Council) exercise referral scheme will be recruited and randomised to one of the two exercise groups (existing Active Sefton Scheme gym based training or home-based HIT). All participants will have access to the normal Active Sefton support mechanisms, but the training programme followed will be different. Before and after 12 weeks of training volunteers will participate in testing to assess changes in aerobic fitness, physical activity, vascular function, insulin sensitivity, body composition and psychological well-being. A 3 month follow up will also be completed to investigate the long term consequences on these variables.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Referred to Active Sefton Exercise Referral scheme by a GP Aged 18-65
Referral criteria:
High blood pressure Angina (treated and stable) Mental Health issues (anxiety/ stress/ depression) Previous Heart attack or heart surgery (not under current investigation) Diabetes type 1 or 2 Impaired glucose tolerance Overweight/ obese (BMI \>30)
Exclusion Criteria:
* Aged \<18 or \>65
* Cardiac rehab patient
* In order to take part participants should have a good grasp of spoken English
* Blood pressure \>180/100 and/or uncontrolled or poorly controlled hypertension
* Currently prescribed Beta-blockers
* Cardiomyopathy
* Uncontrolled tachycardia
* Cardiac arrhythmia
* Valvular heart disease
* Aneurysms
* Diabetes and 1 of the following:
* Aged \>35
* Type 2 diabetes mellitus \>10 yr duration
* Type 1 diabetes mellitus \>15 yr duration
* Hypercholesterolemia (total cholesterol \>6.2 mmol/l)
* Hypertension (systolic blood pressure \>140 or diastolic \>90 mm Hg)
* Smoking
* Family history of coronary artery disease (CAD) in first-degree relative \<60 yr o Presence of microvascular disease
* Peripheral vascular disease
* Autonomic neuropathy
* Uncontrolled (drug resistant) epilepsy - failed to become (and stay) seizure free following trials of two seizure medications.
* History of falls or dizzy spells in the last 12 months
* Excessive or unexplained breathlessness on exertion
* Uncontrolled or poorly controlled asthma (severe COPD) - Limitation …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.