Remote Maintenance Cardiac Rehabilitation: a Randomised Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Intervention feasibility assessed via number of screened patients.
研究概览
简要总结
The investigators would like to test the feasibility of a remotely prescribed and monitored exercise program in people with coronary heart disease, using a wearable activity device and text message support, compared to usual care after completing cardiac rehabilitation. One group will use a Polar Ignite watch to guide them through exercise sessions at home and will receive text message feedback. The other group will be asked to continue their routine as usual. Assessments of both groups will happen after the completion of cardiac rehabilitation and at three follow-up time points of three, six, and twelve months. The aim of these treatments is to see if the investigators can help people to maintain their exercise adherence and coronary heart disease risk factor management after completing cardiac rehabilitation.
详细描述
Following the completion of centre-based cardiac rehabilitation (CR), lifetime adoption of physical activity (PA) and adherence to exercise is often poor. Wearable activity monitors may be a tool to remotely prescribe and monitor PA and exercise to promote long term behaviour change. This research aims to assess the feasibility of conducting a randomised controlled trial (RCT) testing a remotely prescribed and monitored long-term maintenance exercise programme in cardiac rehabilitation graduates with coronary heart disease (CHD). 30 participants with CHD will be recruited to a 12-month feasibility RCT and randomised into 2 arms: 1) a home-based watch intervention group and 2) a best practice usual care control group. The intervention group will receive an initial exercise consultation, personalised exercise prescription delivered via a Polar Ignite watch, and monitoring via check-ins and feedback text-message support with a clinical exercise physiologist. The control group will receive no intervention. All participants will undergo assessment at baseline (following the completion of CR) and at 3 follow up time points including 3-, 6- and 12-months. The primary outcome will be to assess feasibility and other process-related outcomes. The secondary outcomes will include exercise capacity, physical activity and sedentary behaviour, exercise time, cardiovascular disease risk, quality of life, depression, anxiety, self-efficacy, patient activation, health utility, health and social care resource use, cost, and adverse and serious adverse events. Semi-structured interviews will be conducted at 3-, 6-, and 12-months post-randomisation to explore the views, perceptions, acceptability, and experiences of the remotely prescribed and monitored exercise intervention and trial procedures. Participants who drop out or choose not to participate will be offered a semi-structured interview or a questionnaire, respectively, to understand feasibility. Overall, there is a need to support people post-CR to remotely maintain PA and exercise behaviour for secondary prevention of CHD particularly during the era of government-enforced restrictions or lockdowns due to the COVID-19 pandemic. The MAINTAIN study will assess the feasibility of longer-term remote prescription and monitoring of maintenance exercise following CR using a wearable activity monitor and text message support compared to best practice usual care for people diagnosed with CHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
The researcher carrying out the follow up assessments will be blinded to the arm participants have been randomised to.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed coronary heart disease.
- •Completed community cardiac rehabilitation.
- •Clinically stable (symptoms and medication).
- •Men and women aged over
- •Access to smartphone with Bluetooth capacity or a computer/laptop.
- •Able to provide informed consent.
排除标准
- •Absolute contraindications to exercise as per international clinical guidelines.
- •Any serious mental health/cognitive issue that will prevent engagement with study procedures or increase the risk of exercise complications.
- •Diagnosed atrial fibrillation or other arrhythmia preventing accurate heart rate measurement.
- •Allergy to watch materials.
结局指标
主要结局
Intervention feasibility assessed via number of screened patients.
时间窗: Will be evaluated after the 12-month follow up assessment
The investigators will complete screening logs to record the number of eligible participants.
Intervention feasibility assessed via number of patients randomised.
时间窗: Will be evaluated after the 12-month follow up assessment
The investigators will complete randomisation logs to record the number of participants randomised to both groups.
Adherence to the prescribed exercise sessions.
时间窗: Will be evaluated after the 12-month follow up assessment.
The investigators will collect exercise session data recorded by the Polar Ignite watches worn by the participants in the intervention arm. The percentage of prescribed exercise sessions completed will be assessed.
Adherence to the prescribed exercise sessions' intensity.
时间窗: Will be evaluated after the 12-month follow up assessment.
The investigators will collect exercise session data recorded by the Polar Ignite watches worn by the participants in the intervention arm. The percentage of exercise time completed at the correct intensity will be assessed.
Adherence to the prescribed exercise sessions' duration.
时间窗: Will be evaluated after the 12-month follow up assessment.
The investigators will collect exercise session data recorded by the Polar Ignite watches worn by the participants in the intervention arm. The percentage of exercise time completed at the correct duration will be assessed.
Trial acceptability of the interventions and trial procedures via participant interviews
时间窗: Interviews at 12 months
Qualitative semi-structured interviews carried out with control and intervention participants as well as interviews with participants who withdraw from the study.
Intervention feasibility assessed via recruitment rate.
时间窗: Will be evaluated after the 12-month follow up assessment
The investigators will complete enrolment logs to record the number of people who enrol in the study.
Intervention feasibility assessed via number of patients retained in the study.
时间窗: Will be evaluated after the 12-month follow up assessment
The investigators will assess the number of participants who withdraw or stay within the study.
次要结局
- Depression using the Patient Health Questionnaire (PHQ-9)(Baseline, 3-, 6-, and 12-months post randomisation.)
- Cardiovascular disease risk using the Second Manifestations of Arterial disease (SMART) risk score(Measured at baseline, 3-, 6- and 12-month follow up)
- Cardiac specific quality of life using the MacNew Quality of Life Questionnaire(Baseline, 3-, 6-, and 12-months post randomisation.)
- Exercise capacity determined using an Incremental Shuttle Walk Test (ISWT).(Baseline, 3-, 6- and 12 month follow up post randomisation)
- Patient activation using the Patient Activation Measure(Baseline, 3-, 6-, and 12-months post randomisation.)
- Health utility using the EQ-5D-5L(Baseline, 3-, 6-, and 12-months post randomisation.)
- Physical activity and sedentary behaviour(The Actigraph will be worn during the baseline assessment and the 3-, 6, and 12-month follow up post randomisation.)
- Exercise frequency and intensity(It will be completed monthly from baseline to the 12-month follow up period to assess change over time.)
- Anxiety using the Generalised Anxiety Disorder 7-item Scale (GAD-7)(Baseline, 3-, 6-, and 12-months post randomisation.)
- Health and social care resource use using the Client Service Receipt Inventory (CSRI)(Baseline, 3-, 6-, and 12-months post randomisation.)
- Self efficacy using the General Self-Efficacy Scale (GSE)(Baseline, 3-, 6-, and 12-months post randomisation.)
- Cost of the study(Baseline, 3-, 6-, and 12-months post randomisation.)
- Safety assessed via adverse and serious adverse events(Baseline, 3-, 6-, and 12-months post randomisation.)
研究者
Francesca Denton
Chief Investigator
Coventry University