High Intensity Interval Training in Chronic Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05659420
• Other study ID #: InhaUH
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2023
• Source: Inha University Hospital
• Contact: Kyung-Lim Joa, M.D.
• Phone: +82-10-9111-9432
• Email: drjoakl[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• Chronic Heart Failure
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Inha University hospital	Incheon	Kyunggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Inha University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	6minute walk test (meter)		compare baseline data with 12 weeks rehabilitation data
Secondary	maximal heart rate (bpm)		compare baseline data with 12 weeks rehabilitation data
Secondary	systolic blood pressure (mmHg)		compare baseline data with 12 weeks rehabilitation data
Secondary	diastolic blood pressure (mmHg)		compare baseline data with 12 weeks rehabilitation data
Secondary	resting heart rate (bpm)		compare baseline data with 12 weeks rehabilitation data
Secondary	diastolic blood presure (mmHg)		compare baseline data with 12 weeks rehabilitation data
Secondary	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
Secondary	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
Secondary	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
Secondary	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