High Intensity Interval Training in Chronic Heart Failure

Study Overview
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Brief Summary
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The aim of this study is to investigate the effect of high-intensity interval training and moderate intensity continuous training on cardiopulmonary functions in chronic heart failure.

Detailed Description
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enroll chronic heart failure patients into 3 randomized controlled group high intensity interval training moderate intensity continous training control perform cardica rehab for 12 weeks, compare primary and secondary endpoints between baseline and 12 weeks results

Official Title
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The Effect of High-intensity Interval Training and Moderate Intensity Continuous Training on Cardiopulmonary Functions in Chronic Heart Failure

Conditions
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Chronic Heart Failure, Cardiac Rehabilitation

Intervention / Treatment
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* Behavioral: Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: medically stable chronic heart failure NYHA II-III can perform cardiopulmonary exercise test after 3months with proper medication age 30 to 70 ejection fraction< 40% Exclusion Criteria: contraindication to cardiopulmonary exercise test musculoskeletal problem who cannot perform cardiopulmonary exercise test cognition deficit who cannot understand directions severe medial illness

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High intensity interval training<br> | Behavioral: Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor<br>* aerobic exercise on a treadmill (T7M, Motus, Paju, South Korea) accompanied by an electrocardiogram monitoring device (Q-Tel Rehabilitation Management System, Mortara Inc., Milwaukee, WI, USA) and a blood pressure monitor<br>|
| Active Comparator: Moderate intensity continous training<br> | Behavioral: Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor<br>* aerobic exercise on a treadmill (T7M, Motus, Paju, South Korea) accompanied by an electrocardiogram monitoring device (Q-Tel Rehabilitation Management System, Mortara Inc., Milwaukee, WI, USA) and a blood pressure monitor<br>|
| Placebo Comparator: Control<br> | Behavioral: Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor<br>* aerobic exercise on a treadmill (T7M, Motus, Paju, South Korea) accompanied by an electrocardiogram monitoring device (Q-Tel Rehabilitation Management System, Mortara Inc., Milwaukee, WI, USA) and a blood pressure monitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal or peak oxygen consumption (VO2max or VO2peak, same meaning) (kg/ml/min) | at the end of training, from baseline to 12 weeks | compare baseline data with 12 weeks rehabilitation data | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anaerobic threshold (kg/ml/min) | The anaerobic threshold is the highest exercise intensity that you can sustain for a prolonged period without lactate substantially building up in your blood. | compare baseline data with 12 weeks rehabilitation data | 
| 6minute walk test (meter) |  | compare baseline data with 12 weeks rehabilitation data | 
| maximal heart rate (bpm) |  | compare baseline data with 12 weeks rehabilitation data | 
| systolic blood pressure (mmHg) |  | compare baseline data with 12 weeks rehabilitation data | 
| diastolic blood pressure (mmHg) |  | compare baseline data with 12 weeks rehabilitation data | 
| resting heart rate (bpm) |  | compare baseline data with 12 weeks rehabilitation data | 
| diastolic blood presure (mmHg) |  | compare baseline data with 12 weeks rehabilitation data | 
| depression scale by Patient Health Questionnaire | Patient Health Questionnaire (PHQ; range, 0-27; higher score = severe depression; cut-off score of 5 for minimal depression) | compare baseline data with 12 weeks rehabilitation data | 
| anxiety scale by Generalized Anxiety Disorder Scale | Generalized Anxiety Disorder Scale (GAD; range, 0-21; higher score = severe anxiety; cut-off score of 5 for mild anxiety) | compare baseline data with 12 weeks rehabilitation data | 
| fatigue scale by fatigue severity scale | fatigue severity scale (FSS; range, 9-63; higher score = severe fatigue; cut-off score of 4 for fatigue) | compare baseline data with 12 weeks rehabilitation data | 
| Quality of Life (QoL) questionnaire (MacNew) | MacNew QoL questionnaire is a measurement tool for patients with cardiac disease that measures physical, emotional, and social functional levels to provide overall QoL. | compare baseline data with 12 weeks rehabilitation data |