跳至主要内容
临床试验/NCT04074057
NCT04074057Unknown不适用

Effectiveness of a Novel Mobile App Based Cardiac Rehabilitation Compared to Traditional Centre-based, Therapist Driven Cardiac Rehabilitation for Patients Post Coronary Revascularisation : A Non-inferiority Pilot Study

Tan Tock Seng Hospital1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
34
试验地点
1
主要终点
6 minutes walk test

研究概览

简要总结

n Tan Tock Seng (TTSH), Acute myocardial infarction (AMI) is one of the top 4 reasons for admissions with 948 percutaneous coronary intervention (PCI) procedures done in year 2016. International guidelines recommend that all patients complete CR after PCI, as it plays a critical role in reducing five-year cardiovascular mortality and the risk of cardiovascular-related hospital admission. However, the rate of completion of CR has been found to be low as only 19% of post PCI patients completed CR in 2016. According to a patient survey conducted, the main reason for non-completion is the inconvenience experienced by patients from needing to return to hospital weekly. In addition, poor compliance to prescribed home exercises limits the effectiveness of exercise training. Hence, there is a pertinent need to activate patients to engage in self-directed CR in a safe and effective manner to target these issues. Current solutions to increase participation and compliance involve strategies have been limited. Participation and compliance to prescribed exercises recorded via brochures and activity diaries have been limited by difficulties experienced by patients when providing this information, posing a risk of recall bias or the risk of misplacing their activity logs. Mobile applications targeted at increasing fitness addresses the problem of the risk of misplacing activity logs but is still subjected to recall bias as self-input of multiple data is required. Exercise guidelines within these applications are also generic and does not adhere to international exercise training guidelines targeted at patients after coronary revascularisation. In order to address these gaps, there is a need for a technology enabled solution that can provide evidence-based CR programme with constant HR monitoring which offers direct feedback to the patients and at the same time affordable and easy to use. "Heart-Track" is a novel mobile app based CR model of care that utilises a technology-enabled device designed specifically for patients post PCI to complete CR at their convenience, while ensuring that evidence-based clinical outcomes are achieved.

详细描述

In Tan Tock Seng (TTSH), Acute myocardial infarction (AMI) is one of the top 4 reasons for admissions with 948 percutaneous coronary intervention (PCI) procedures done in year 2016. International guidelines recommend that all patients complete CR after PCI, as it plays a critical role in reducing five-year cardiovascular mortality and the risk of cardiovascular-related hospital admission. However, the rate of completion of CR has been found to be low as only 19% of post PCI patients completed CR in 2016. According to a patient survey conducted, the main reason for non-completion is the inconvenience experienced by patients from needing to return to hospital weekly. In addition, poor compliance to prescribed home exercises limits the effectiveness of exercise training. Hence, there is a pertinent need to activate patients to engage in self-directed CR in a safe and effective manner to target these issues. Current solutions to increase participation and compliance involve strategies have been limited. Participation and compliance to prescribed exercises recorded via brochures and activity diaries have been limited by difficulties experienced by patients when providing this information, posing a risk of recall bias or the risk of misplacing their activity logs. Mobile applications targeted at increasing fitness addresses the problem of the risk of misplacing activity logs but is still subjected to recall bias as self-input of multiple data is required. Exercise guidelines within these applications are also generic and does not adhere to international exercise training guidelines targeted at patients after coronary revascularisation. In order to address these gaps, there is a need for a technology enabled solution that can provide evidence-based CR programme with constant HR monitoring which offers direct feedback to the patients and at the same time affordable and easy to use. "Heart-Track" is a novel mobile app based CR model of care that utilises a technology-enabled device designed specifically for patients post PCI to complete CR at their convenience, while ensuring that evidence-based clinical outcomes are achieved. The key components of "Heart-Track" are: 1. Exercise principles based on international guidelines 2. Gamification; 3. Continuous heart rate monitoring; 4. Adaptation to local context. As Heart-track is the first of its kind, being designed for use in the local context, findings from research is important in determining its efficacy when compared to traditional cardiac rehabilitation.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Randomization and group allocation are done by the research coordinator. Final assessment is also arranged by research coordinator. Blinded assessor will conduct the final assessment

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 21-65 years old
  • Underwent coronary revascularisation follow AMI
  • Language literacy English or Mandarin
  • Owns a smart phone
  • Normal physiological response during exercise testing
  • Low or moderate risk following risk stratification.

排除标准

  • Medically unfit for exercise
  • Post op complication
  • High risk following risk stratification
  • Cognitive impaired

研究组 & 干预措施

Control arm

Other

the control group will undergo a conventional weekly CR programme lasting 8-12 sessions. Components of each session will include warm up, aerobic training, resistance exercises and cool down. Patients are encouraged to continue their home exercises, exercising another 2 times a week at home and record down using an activity diary. The importance of CR programme and exercise advice will be explained and reinforced by the CR Physiotherapist. The submaximal exercise test and a body composition analysis will be repeated on the final assessment. Every week research coordinator will call the subject to remind them to exercise.

干预措施: Conventional Cardiac Rehab Classes (Other)

Intervention arm

Other

During the initial assessment, the importance of CR and regular exercise will be explained and reinforced by CR physiotherapist. A research assistant will teach the patient how to use "Heart Track". The patient will then bring "Heart Track" home to continue their CR program. Patient will then undergo the whole CR programme to exercise for 3 times a day for 8-12 weeks using "Heart Track". Each "Heart Track" session will include warm up, aerobic training, resistance exercises and cool down (same as the traditional CR session). After 8-12 weeks, patient will be called back to the clinic by the research assistant to complete the final assessment (sub-maximal exercise test and a body composition analysis) with the blinded assessor. Every week research coordinator will call the subject to remind them to exercise.

干预措施: Heart Track (Device)

结局指标

主要结局

6 minutes walk test

时间窗: through study completion, an average of 1 year

The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The MCID for 6MWD in patients with CAD after ACS was 25m.

Body Mass Index

时间窗: through study completion, an average of 1 year

Measure of body fat based on height and weight that applies to adult men and women. Calculated by using body weight and height (kg/m2)

Waist Hip Ratio

时间窗: through study completion, an average of 1 year

Assess using a bioelectrical impedance analysis (BIA) method

Skeletal muscle mass

时间窗: through study completion, an average of 1 year

Assess using a bioelectrical impedance analysis (BIA) method, record in kg

Body Height

时间窗: through study completion, an average of 1 year

Body height will be assessed, record in meter

Body weight

时间窗: through study completion, an average of 1 year

Body weight will be assessed , record in kg

Body Fat Percentage

时间窗: through study completion, an average of 1 year

Assess using a bioelectrical impedance analysis (BIA) method, record in percentage %

Borg's RPE scale

时间窗: through study completion, an average of 1 year

Rating of perceived exertion (RPE) is a widely used and reliable indicator to monitor and guide exercise intensity. The scale allows individuals to subjectively rate their level of exertion during exercise or exercise testing. body fat,Skeletal muscle mass, Waist-hip ratio can be measured by using the body composition analysis machine. Borg scale 6-20, 6 is very very light and 20 is very very hard.

次要结局

  • Health related QoL: MacNew myocardial infarction Quality of life questionnaire(through study completion, an average of 1 year)
  • Self-Efficacy for Exercise Scale•(through study completion, an average of 1 year)
  • Patient-reported survey on usability of Heart Track acceptability(through study completion, an average of 1 year)

研究者

发起方
Tan Tock Seng Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eng Chan Neoh

Senior Physiotherapist

Tan Tock Seng Hospital

研究点 (1)

Loading locations...

相似试验