Feasibility and Preliminary Evaluation and the Effects of Exercise-based Telerehabilitation on the Acceptability and Safety, and Clinical Effectiveness Among Patients With Coronary Heart Disease Undergoing the Cardiac Rehabilitation Program
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
- Exercise capacity during exercise stress test
研究概览
简要总结
The intervention will involve a system that comprises a wrist-worn activity tracker and a smartphone app that acts as a medium to link to the healthcare website
详细描述
Feasibility study objective: - To investigate the feasibility and preliminary of exercise-based telerehabilitation before undertaking full-scale RCT.
Randomized control trial objective: -
- Primary Objective: To determine the exercise capacity among patients with CHD,
- Secondary Objectives: To assess patient exercise adherence and determine the changes in other clinical health outcomes.
Study Population: Patients with coronary heart disease
Description of Sites/Facilities Enrolling Participants: Patient engagement with the cardiac rehabilitation phase 2 (CRP2) at the University Malaya Medical Centre (UMMC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The masking will be imposed on the investigator who will be involved with the recruitment of the participant to prevent selection bias. The allocation of the participant to a group will be randomised using computer-generated random numbers by the other investigator who did not involve in recruiting the participant.
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
- •Adults with 18 years old and above with indexed diagnosis of coronary heart disease (CHD) and are referred for Cardiac Rehabilitation Program;
- •Low- and moderate-risk patient category (controlled BP, sinus rhythm at 60-90 bpm, pain score< 3/10) and received a statement of medical clearance by a CR physician to undertake exercise with minimal supervision;
- •The patient is willing to wear trackers during waking hours, own a personal smartphone and have access to internet/Wi-Fi; and
- •Participant must be able to able to read, speak and understand English and Malay.
排除标准
- •Heart failure NYHA Stage 3-4, pulse undetected by trackers;
- •The participant who cannot detect their pulse through wrist-worn tracker;
- •Do not own a smartphone with the mobile internet/Wi-Fi ; and
- •Contraindicated for an exercise stress test and concomitant morbidity that limit physical activity and exercise.
结局指标
主要结局
Exercise capacity during exercise stress test
时间窗: 12 weeks
Changes of metabolic equivalents (METs)
Exercise capacity during six-minutes walking test
时间窗: 12 weeks
Changes of walking distance (meter)
Feasibility (Safety - cardiac adverse events)
时间窗: 12 weeks
To inform the patient's safety on cardiac adverse events
Feasibility (Safety - hospital readmission)
时间窗: 12 weeks
To inform the patient's safety on hospital readmission
Feasibility (Recruitment procedure)
时间窗: 12 weeks
To inform the patient's acceptability towards recruitment procedure
Feasibility (Cardiac rehabilitation program adherence)
时间窗: 12 weeks
To inform the patient's acceptability towards cardiac rehabilitation program adherence
Feasibility (Randomization procedure)
时间窗: 12 weeks
To inform the patient's acceptability towards randomization procedure
Feasibility (Assessment adherence)
时间窗: 12 weeks
To inform the patient's acceptability towards assessment adherence
次要结局
- Blood collection - high-density lipoproteins (HDL)(12 weeks)
- Body mass index (BMI) (kg/m2)(12 weeks)
- Usability scale score(12 weeks)
- Exercise adherence - Steps count(12 weeks)
- Exercise adherence - Exercise duration(12 weeks)
- Hospital readmission(12 weeks)
- Exercise adherence - Exercise frequency(12 weeks)
- Cardiac adverse events(12 weeks)
- Blood collection - serum cholesterol(12 weeks)
- Blood collection - triglyceride(12 weeks)
- Blood collection - low-density lipoprotein (LDL)(12 weeks)
- Blood collection - Haemoglobin A1C (HA1c)(12 weeks)
- Participant's acceptance to the exercise-based telemonitoring(12 weeks)
- Body mass (kg)(12 weeks)
- Factors associated with non-adherence to cardiac rehabilitation program score(12 weeks)
- Quality of life (QOL) score(12 weeks)
- Fitness tracker acceptance score(12 weeks)