High Intensity Interval Training in Chronic Heart Failure

• Sponsor: Inha University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05659420
• Collaborator: (none)
• Enrollment: 60
• Arms: 3
• Anticipated Duration (Months): 36

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure; Cardiac Rehabilitation	Behavioral: Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of High-intensity Interval Training and Moderate Intensity Continuous Training on Cardiopulmonary Functions in Chronic Heart Failure
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Jul 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High intensity interval training	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
Active Comparator: Moderate intensity continous training	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
Placebo Comparator: Control	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 6minute walk test (meter) [compare baseline data with 12 weeks rehabilitation data]

3. maximal heart rate (bpm) [compare baseline data with 12 weeks rehabilitation data]

4. systolic blood pressure (mmHg) [compare baseline data with 12 weeks rehabilitation data]

5. diastolic blood pressure (mmHg) [compare baseline data with 12 weeks rehabilitation data]

6. resting heart rate (bpm) [compare baseline data with 12 weeks rehabilitation data]

7. diastolic blood presure (mmHg) [compare baseline data with 12 weeks rehabilitation data]

8. 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)

9. 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)

10. 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)

11. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Inha University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joa KyungLim, professor, M.D. Ph.D, Inha University Hospital
• ClinicalTrials.gov Identifier: NCT05659420
• Other Study ID Numbers: InhaUH
• First Posted: Dec 21, 2022
• Last Update Posted: Dec 21, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Dec 21, 2022