Manipulating Exercise Intensity and Affective Responses on a Cardiac Rehabiliattion Program for Patients With Acute Coronary Syndrome: Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 3
- 主要终点
- Physical activity levels by International Physical Activity Questionnaire - Short Form
研究概览
简要总结
The goal of this clinical trial is to learn if pleasure-oriented exercise intensity manipulation increases physical activity (PA) behavior in patients who have suffered acute coronary syndrome during a cardiac rehabilitation program. The main question it aims to answer is:
• the manipulation of exercise intensity performed to produce more pleasure and arousal will impact the PA behavior? Researchers will compare the PA levels and affective responses to see if the manipulation of exercise intensity guided to pleasure and arousal works to increase PA behavior compared to the control group who will follow a conventional exercise program.
Participants will do:
- sixteen individualized hospital exercise sessions (two per week) and complementary physical activity program integrated into their daily life
- be evaluated before and at the end of the exercise sessions and after 3 months
详细描述
Ischaemic heart disease remains the top global cause of death, with cases rising by 2.7 million to 9.0 million deaths over the past two decades and between 1990-2019 the percentage of years of life lived with disability increased 83%.
Ischaemic heart disease includes acute coronary syndromes (ACS) that consist of acute myocardial infarction (AMI) and unstable angina. After ACS there is a greater risk of recurrence of the event, arrhythmias, heart failure and sudden death. These patients also have a lower quality of life which impacts their physical function and psychological well-being. ACS represent a substantial direct cost and economic burden for national health systems. Prevention must be prioritized and the emphasis on encouraging physical activity (PA) and routine exercise has become more vital than ever.
The 2023 European Society of Cardiology Guidelines for the management of ACS recommend that all patients participate in a medically supervised, structured, comprehensive cardiac rehabilitation (CR) program with a multidisciplinary team. Its core components are patient assessment, management and control of cardiovascular risk factors, PA counselling, prescription of exercise training, dietary advice, tobacco counselling, patient education, psychosocial management, and vocational support. Exercise plays a key role having a Class I, Level A evidence supporting its benefits, while specific components such as aerobic PA and muscle-strengthening exercises are supported by Class I, Level B evidence. CR plays a crucial role in lowering rates of hospitalization, fatal and non-fatal myocardial infartion, while improving exercise capacity and quality of life. There is also a reduction in healthcare costs for participants in a CR program compared with nonparticipants.
CR typically consists of three phases: phase 1 (in-hospital), phase 2 (mostly in an outpatient setting: centre-based or home-based) and phase 3 (maintenance phase in outpatient or community settings, aimed at sustaining lifestyle changes). Phase 2 CR is typically provided as an outpatient program, lasting between 8 to 24 weeks, with sessions offered 3 to 7 days per week.
A progressive program of structured exercise and PA are a fundamental part of a CR program. Exercise training should be tailored to the individual, following a thorough clinical assessment that includes risk stratification, behavioral traits, personal objectives, and exercise preferences. Exercise should be prescribed based on FITT-VP (frequency, intensity, time, type of exercise, volume, and progression) model. It is recommended to do aerobic training at a frequency of at least 3 days per week, with a preference for 6-7 days per week, at a moderate or moderate-to-high intensity. It is also advised to do resistance training, 2 days per week, at 30-70% of one-repetition maximum (1RM) for the upper body and 40-80% of 1RM for the lower body, with 12-15 repetitions/set. After the end of the CR program (i.e., beginning of phase 3), ACS patients should accumulate at least 30 minutes per day, 5 days per week of moderate intensity PA (equating to 150 minutes per week) or 15 minutes per day, 5 days per week of vigorous intensity PA (equating to 75 minutes per week), or a combination of both. These PA levels are needed for reducing disease progression and increasing quality of life.
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 (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
- •Selection criteria include:
- •patients older than 18 years
- •diagnosis of ACS within the past 12 months who have not previously participated in a CR program
- •patients classified as low-risk (Class B) according to the American Heart Association: (a) New York Heart Association (NYHA) class I or II, (b) exercise capacity greater than 6 METs, (c) no evidence of heart failure, (d) no signs of myocardial ischemia or angina at rest or during exercise testing at or below 6 METs, (e) appropriate systolic blood pressure response during exercise, and (f) absence of sustained or non-sustained ventricular tachycardia at rest or during exercise.
排除标准
- •left ventricular ejection fraction (LVEF) < 40% at rest
- •uncontrolled arrythmias (e.g., complex ventricular arrhythmias, atrial fibrillation or flutter with rapid ventricular response, second-degree atrioventricular block Mobitz type II, or third-degree atrioventricular block)
- •presence of an implantable cardiac device
- •symptomatic peripheral arterial disease
- •comorbidities that may interfere with the ability to perform the exercise program safely.
研究组 & 干预措施
Control
干预措施: Control (Other)
Experimental
干预措施: Experimental (Other)
结局指标
主要结局
Physical activity levels by International Physical Activity Questionnaire - Short Form
时间窗: At baseline (the week before phase 2 cardiac rehabilitation program), end of the intervention (first week after the intervention) and at 3 months after it
International Physical Activity Questionnaire - Short Form: physical activity will be assessed by a continuous variable, expressed in MET-minutes per week. It will be applied in order to evaluate the same week of accelerometry.
Affective responses in exercise sessions phase 2 cardiac rehabilitation program - Felt Arousal Scale
时间窗: During all exercise sessions (twice a week for 8 weeks) will be administered at 10-min intervals during the aerobic activity; immediately after the fourth and eighth resistance exercises set and in the last 15 sec of the set of the fifth stretch exercise
Felt Arousal Scale is a 6-point scale ranging from 1 ("Low arousal") to 6 ("High arousal") that assesses perceived activation
Physical activity levels by accelerometry
时间窗: At baseline (the week before phase 2 cardiac rehabilitation program), end of the intervention (first week after the intervention) and at 3 months after it
We will use the ActiGraph® GT3X+ (Pensacola, FL) accelerometer. The researcher will distribute the accelerometers to all participants, that will be instructed to wear the device on an elastic belt around their waist on the right side for seven consecutive days, taking it off only for water-based activities (e.g., shower and swimming) and sleep. Participants will be asked to carry out their usual activities during data collection. The cut points and wear time validation criteria will be used to define the time spent in each intensity period and to define a valid register. A day will be considered valid with at least 600 minutes of use, and each participant will have to present at least four valid days, including a at least one weekend day to be included in the analysis. Compliance with PA recommendations for public health will be assessed according to EAPC recommendations (150 min/week of MVPA defined as ≥ 21.4 min/day).
Affective responses in exercise sessions phase 2 cardiac rehabilitation program - Feeling Scale
时间窗: During all exercise sessions (twice a week for 8 weeks) will be administered at 10-min intervals during the aerobic activity; immediately after the fourth and eighth resistance exercises set and in the last 15 sec of the set of the fifth stretch exercise
Feeling Scale is an 11-point scale ranging from -5 ("Very bad") to +5 ("Very good"), which assesses the affective valence (how one feels at that given moment)
次要结局
- Participation in the complementary physical activity program(In the 8 weeks of the intervention)
- Anticipated affective response(5 minutes before the exercise sessions 1, 8 and 16 during the intervention (exercise sessions are twice a week for 8 weeks))
- Intention to continue exercising(5 min before session 1 and 5 min after session 16 during intervention (exercise sessions are twice a week for 8 weeks). At the end of the intervention (first week after the intervention) and at 3 months after it)
- Exercise habit(5 min before session 1 and 5 min after session 16 during intervention (exercise sessions are twice a week for 8 weeks). At the end of the intervention (first week after the intervention) and at 3 months after it)
- Final remembered affect to the previous exercise session(5 minutes after exercise sessions 1, 8 and 16 during intervention (exercise sessions are twice a week for 8 weeks))
- Exercise enjoyment(5 minutes before session 1 and 5 minutes after sessions 8 and 16 during intervention (exercise sessions are twice a week for 8 weeks).)
- Intensity preference, tolerance, and agreement of exercise(5 minutes before session 1 and 5 minutes after session 8 and 16 during intervention (exercise sessions are twice a week for 8 weeks).)
- Motivation to exercise(5 minutes before session 1 and 5 minutes after session 8 and 16 during intervention (exercise sessions are twice a week for 8 weeks).)
- Abdominal Circumference(Baseline, at the end of the intervention (first week after the intervention) and at 3 months after it)
- Autonomy in exercise practice(5 minutes before session 1 and 5 minutes after session 8 and 16 during intervention (exercise sessions are twice a week for 8 weeks).)
- Body mass index (BMI)(Baseline, at the end of the intervention (first week after the intervention) and at 3 months after it)
- Body weight(Baseline, at the end of the intervention (first week after the intervention) and at 3 months after it)
- Height(Baseline)
研究者
Filipa Januario
Collaborator Member
Instituto Politécnico de Leiria
