Risk Factor, Cardiovascular Clinical Trial
Official title:
Home-based High Intensity Interval Training is Effective in a Primary Care Setting for at Risk Individuals: A Multidisciplinary Approach Evaluating Health and Perceived Barriers to Exercise
Verified date | September 2020 |
Source | Liverpool John Moores University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 154 |
Est. completion date | September 19, 2019 |
Est. primary completion date | September 19, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 in performing day-to-day activities, weekly nocturnal symptoms and awakening, more need for rescue medications, lung function (FEV1) < 80%, three or more asthma attacks per year - Pregnant or breast feeding or becomes pregnant during the study - End stage renal disease - Awaiting medical investigation - Severe mental health condition - Any other medical condition or condition that would make them unsuitable for an exercise programme. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Liverpool John Moores University | Liverpool |
Lead Sponsor | Collaborator |
---|---|
Liverpool John Moores University | Loughborough University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiorespiratory fitness | Incremental exercise test to exhaustion to assess VO2peak | 3 months | |
Secondary | Body composition | via DXA | 3 months | |
Secondary | Insulin Sensitivity | Oral Glucose Tolerance Test | 3 months | |
Secondary | Exercise Adherence | Participants to record all complete exercise sessions using a Bluetooth compatible heart rate monitor, linked to cloud data storage. Research team will have access to cloud storage to assess the number of exercise sessions completed. | 3 months |
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