High Intensity Interval Training in Chronic Heart Failure

Not Applicable

Recruiting

• Conditions: Cardiac Rehabilitation; Chronic Heart Failure
• Interventions: Behavioral: Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor

• Registration Number: NCT05659420
• Lead Sponsor: Inha University Hospital

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-21
• Study Start: 2023-01-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-02
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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%

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Exclusion Criteria

• contraindication to cardiopulmonary exercise test
• musculoskeletal problem who cannot perform cardiopulmonary exercise test
• cognition deficit who cannot understand directions
• severe medial illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High intensity interval training	Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor	-
Moderate intensity continous training	Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor	-
Control	Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor	-

Primary Outcome Measures

Name	Time	Method
Maximal or peak oxygen consumption (VO2max or VO2peak, same meaning) (kg/ml/min)	compare baseline data with 12 weeks rehabilitation data	at the end of training, from baseline to 12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Inha University hospital; 🇰🇷 Incheon, Kyunggi-do, Korea, Republic of