Feasibility and Effectiveness of an Additional Resistance and Balance Training in Cardiac Rehabilitation of Older Patients After Valve Surgery or Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Functional capacity by six minutes walking test (6MWT)
研究概览
简要总结
The aim of the study is to evaluate the short- and medium-term effectiveness of additional moderate dynamic resistance and balance training to the CR-program of old adults after valve surgery or intervention compared to usual care-CR.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients after valve surgery and/or intervention
- •Age 65 years and older
- •Ability to start CR within 4 weeks after surgery,
- •6-minute walk distance (6-MWD) ≥100- ≤350 m (1)
- •Patient's agreement to participate in the study.
排除标准
- •Diseases in the musculoskeletal system or other organs complicating physical activity and exercise training;
- •Exercise-limiting comorbidities (primarily orthopedic and neurological conditions that would exclude individuals from participating in CR according to study protocol), including chronic heart failure New York Heart Association Class IV, hemoglobin less than 9 g/dL, wound healing disturbance, cognitive or linguistic deficits.
研究组 & 干预措施
Control group
The supervised exercise program included: continues endurance training on cycle ergometers (6 sessions a week). Every session included warm up (<50% target intensity 2 min, gradually increasing load 1-10 w/min up to target intensity within 5 - 10 min); exercise phase (100% of the target intensity (30-50% watts or 30-50% HRmax), starting with >5 minutes and gradually prolonged up to 30 min); cool down with gradual reduction of the load within 3 minutes); additional aerobic exercises performed sitting and/or standing (30 minutes, 5 days/week); respiratory muscle training (7 days/week, for 15 minutes) using ball trainer.
Intervention group
Exercise program as for a control group together with additional resistance and balance training 3 sessions/week. The resistance training was started with low intensity (<30% 1-RM, RPE ≤ 11, 5-10 repetitions), increased gradually to moderate intensity (30-50% and up to 60% 1-RM, RPE 12-13, after 8-15 repetitions) with 3 sets and 3 minute rest between sets, if tolerated. The balance training included exercises to improve static as well as dynamic balance ability. It was performed on 2-3 days/week for 10-15 minutes. The complexity of the balance exercises was selected and incremented individually by changing the stand-position, the base on which the stands were performed and/or using unstable surfaces. If tolerated, the visual information was varied and/or additional tasks performed while balancing. After completion participants were encouraged to continue exercise training at home according to recommendations.
干预措施: Additional balance and resistance training (Other)
结局指标
主要结局
Functional capacity by six minutes walking test (6MWT)
时间窗: 3 months
6MWT measured by meters
Physical performance by Short Physical Perfromance Battery (SPPB)
时间窗: Three months
The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests.The scores range from 0 (worst performance) to 12 (best performance).
Quality of life by questionnaire Short Form Survey SF-36
时间窗: 3 months
0-100%, the higher score, the better quality of life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) in units on the scale
Quality of life by questionnaire Minnesota living with heart failure (Minesota HF)
时间窗: 3 months
Minesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life
Quality of life by questionnaire EQ-5D
时间窗: 3 months
EQ-5D in units on the scale, 0-10, the higher score, the better quality of life
Physical performance by 5 meters walking test (5MWT)
时间窗: 3 months
5MWT is a gate speed test measured by meters per second.
Quality of life by questionnaire Quality of Life: Cardiac Index
时间窗: 3 months
Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life
Physical performance by Short Physical Perfromance Battery (SPPB)
时间窗: Baseline
The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests.The scores range from 0 (worst performance) to 12 (best performance).
Physical performance by Short Physical Perfromance Battery (SPPB)
时间窗: 20 days
The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests.The scores range from 0 (worst performance) to 12 (best performance).
Physical performance by 5 meters walking test (5MWT)
时间窗: Baseline
5MWT is a gate speed test measured by meters per second.
Physical performance by 5 meters walking test (5MWT)
时间窗: 20 days
5MWT is a gate speed test measured by meters per second.
Functional capacity by six minutes walking test (6MWT)
时间窗: Baseline
6MWT measured by meters
Functional capacity by six minutes walking test (6MWT)
时间窗: 20 days
6MWT measured by meters
Quality of life by questionnaire Short Form Survey SF-36
时间窗: Baseline
0-100%, the higher score, the better quality of life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) in units on the scale
Quality of life by questionnaire Short Form Survey SF-36
时间窗: 20 days
0-100%, the higher score, the better quality of life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) in units on the scale
Quality of life by questionnaire Minnesota living with heart failure (Minesota HF)
时间窗: Baseline
Minesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life
Quality of life by questionnaire Minnesota living with heart failure (Minesota HF)
时间窗: 20 days
Minesota HF questionnaire in units on the scale, 0-105, the the lower score, the better quality of life
Quality of life by questionnaire EQ-5D
时间窗: Baseline
EQ-5D in units on the scale, 0-10, the higher score, the better quality of life
Quality of life by questionnaire EQ-5D
时间窗: 20 days
EQ-5D in units on the scale, 0-10, the higher score, the better quality of life
Quality of life by questionnaire Quality of Life: Cardiac Index
时间窗: Baseline
Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life
Quality of life by questionnaire Quality of Life: Cardiac Index
时间窗: 20 days
Quality of Life: Cardiac Index in units on the scale, 15-33 the higher score, the better quality of life
次要结局
- Frailty level by SPPB score(three months)
- Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)(3 months)
- Muscular strength by one repetition maximum test (1RM)(3 months)
- Frailty level by 5MWT(three months)
- Physical activity by International physical activity questionnaire (IPAQ)(Baseline)
- Cardiopulmonary exercise capacity by maximal load (maxWatt)(3 months)
- Frailty level by SPPB score(baseline)
- Frailty level by SPPB score(20 days)
- Frailty level by 5MWT(baseline)
- Frailty level by 5MWT(20 days)
- Physical activity by International physical activity questionnaire (IPAQ)(3 months)
- Physical activity by International physical activity questionnaire (IPAQ)(20 days)
- Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)(Baseline)
- Cardiopulmonary exercise capacity by maximal load (maxWatt)(Baseline)
- Cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)(20 days)
- Cardiopulmonary exercise capacity by maximal load (maxWatt)(20 days)
- Muscular strength by one repetition maximum test (1RM)(baseline)
- Muscular strength by one repetition maximum test (1RM)(20 days)
研究者
Eglė Tamulevičiūtė-Prascienė
Head of a Rehabilitation department
Lithuanian University of Health Sciences