Comparative Effects Between Neuromuscular Versus Resistance Training on Functional Capacity, Cardiorespiratory Fitness, and Lower Limb Performance in Patients With Heart Failure.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Functional Capacity
研究概览
简要总结
This randomized controlled trial will compare the effects of neuromuscular training and resistance training on functional capacity, cardiorespiratory fitness, and lower limb performance in patients with chronic heart failure. A total of 40 participants will be randomly assigned into two groups in a single-blinded design.
Both groups will undergo a 10-week supervised exercise program. Outcomes will be assessed using VO₂ peak, 6-Minute Walk Test (6MWT), Short Physical Performance Battery (SPPB), and quality of life measures.
The study aims to determine the more effective rehabilitation approach for improving clinical outcomes in heart failure patients.
详细描述
Heart failure is a chronic and progressive condition associated with reduced functional capacity, impaired cardiorespiratory fitness, and decreased lower limb performance, significantly affecting quality of life. Exercise-based cardiac rehabilitation is an established intervention; however, the comparative effectiveness of different exercise modalities, particularly neuromuscular training and resistance training, remains insufficiently explored.
This study is a single-blinded randomized controlled trial designed to compare the effects of neuromuscular training and resistance training on functional capacity, cardiorespiratory fitness, and lower limb performance in patients with chronic heart failure. A total of 40 participants meeting the inclusion criteria will be recruited from tertiary care hospitals and cardiac rehabilitation centers. After baseline assessment, participants will be randomly allocated into two groups using a concealed allocation method.
Both groups will undergo a supervised 10-week intervention program consisting of 20 sessions (2 sessions per week). Each session will include warm-up, 20 minutes of specific training, 20 minutes of moderate-intensity aerobic exercise, and cool-down. The resistance training group will perform exercises targeting major muscle groups at moderate intensity (50-70% of one-repetition maximum), while the neuromuscular training group will focus on balance, coordination, proprioception, and motor control using structured functional exercises.
Primary outcome measures will include cardiorespiratory fitness (VO₂ peak assessed via Chester Step Test), functional capacity (6-Minute Walk Test), and lower limb performance (Short Physical Performance Battery). Secondary outcomes will include resting heart rate, blood pressure, oxygen saturation, perceived exertion (Borg CR-10), and quality of life measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Assessments will be conducted at baseline and after completion of the intervention by a blinded assessor to minimize bias. Data will be analyzed using appropriate statistical methods to compare within-group and between-group differences.
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 (Outcomes Assessor)
盲法说明
This is a single-blinded study in which the outcome assessor will be blinded to group allocation to minimize assessment bias. Participants and therapists will not be blinded due to the nature of the interventions.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 40-60 years
- •Diagnosed with chronic heart failure ≥ 1 year
- •Heart failure with reduced ejection fraction (HFrEF), EF ≤ 40%
- •NYHA Class II-III
- •Low to moderate exercise risk (based on Chester Step Test)
- •On stable pharmacological treatment for ≥ 6 weeks
- •Able to understand and follow exercise instructions
排除标准
- •Absolute contraindications to exercise (e.g., recent MI, unstable angina, uncontrolled arrhythmias, severe aortic stenosis, decompensated HF)
- •Abnormal CPET findings (severe arrhythmias, ischemia, ST depression)
- •Abnormal blood pressure response during exercise
- •Exercise-induced angina or thoracic pain
- •Musculoskeletal, neurological, or cognitive impairments limiting exercise participation
研究组 & 干预措施
Resistance Training Group
Participants in this group will undergo a supervised resistance training program targeting major upper and lower limb muscle groups. Training will be performed at moderate intensity (50-70% of one-repetition maximum) using resistance bands, machines, and bodyweight exercises. Each session will also include 20 minutes of moderate-intensity aerobic exercise, along with warm-up and cool-down, conducted twice weekly for 10 weeks.
干预措施: Resistance Training (Behavioral)
Neuromuscular Training Group
Participants in this group will undergo a supervised neuromuscular training program focusing on balance, coordination, proprioception, postural control, and motor control exercises. Training will include dynamic balance activities, limb coordination tasks, and exercises using unstable surfaces. Each session will also include 20 minutes of moderate-intensity aerobic exercise, along with warm-up and cool-down, conducted twice weekly for 10 weeks.
干预措施: Neuromuscular Training (Behavioral)
结局指标
主要结局
Functional Capacity
时间窗: Baseline and after 10 weeks of intervention
Functional capacity will be assessed using the Six-Minute Walk Test (6MWT), which measures the distance a participant can walk on a flat surface in 6 minutes. It is a validated and reliable measure used in cardiac rehabilitation to evaluate exercise tolerance and daily functional ability in patients with heart failure.
Cardiorespiratory Fitness (VO₂ Peak)
时间窗: Baseline and after 10 weeks of intervention
Cardiorespiratory fitness will be assessed using the Chester Step Test, which estimates VO₂ peak based on heart rate response during graded stepping exercise. VO₂ peak is a key indicator of aerobic capacity and cardiovascular health in patients with heart failure.
Lower Limb Performance
时间窗: Baseline and after 10 weeks of intervention
Lower limb performance will be assessed using the Short Physical Performance Battery (SPPB), which includes balance tests, gait speed, and chair stand tests. It is a validated tool for assessing lower extremity function in clinical populations.
次要结局
未报告次要终点