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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Cardiorespiratory fitness
研究概览
简要总结
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.
详细描述
Randomisation - During the pre-intervention testing session participants will be randomised to either the home-based HIT group (HB_HIT)(n=100) or Active Sefton Exercise Referral Scheme (AS_ERS)(n=100). To control for the potential confounding effects of gender and location, stratified randomisation will be completed. Randomisation will be completed with a random number generator. Participant randomisation will take place during Pre-Intervention Testing.
Recruitment - Participants will be recruited via the AS_ERS. Following referral to the Active Sefton Scheme by their GP, all patients will be sent an invitation letter by the Active Sefton team. The research team will add a short letter outlining the study to patients. All Patients who chose to participate in the Active Sefton Scheme will meet with an Active Lifestyle Development Officer (LDO). During this session the LDO will discuss the study with patients. Interested patients will be given a participant information sheet, and their contact details (email and/or phone) will be given to the Liverpool John Moores University (LJMU) research team. These details will be used to contact the patient to discuss the study further. Should the patient still want to participate a Pre-Intervention Testing session will be organised.
If patients consent to the study the research team will inform Active Sefton with information on the exercise programme the participant has been randomised too.
Protocol and plan of investigation
Pre-Intervention Testing - Participants will attend an experimental trial commencing between 6am and 10am, lasting ̴ 3.15h. Participants will be fasted overnight and instructed to abstain from caffeine, alcohol and moderate/ vigorous exercise the day before testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
- •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.
结局指标
主要结局
Cardiorespiratory fitness
时间窗: 3 months
Incremental exercise test to exhaustion to assess VO2peak
次要结局
- Body composition(3 months)
- Insulin Sensitivity(3 months)
- Exercise Adherence(3 months)