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Clinical Trials/NCT06756659
NCT06756659Active, not recruitingNot Applicable

Comparison of the Effectiveness Between Home-based Cardiac Rehabilitation With Spot-jogging and Outpatient Center-Based Cardiac Rehabilitation in Patients With Heart Failure.

National Taiwan University Hospital1 site in 1 country40 target enrollmentStarted: February 5, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
40
Locations
1
Primary Endpoint
Cardiopulmonary exercise test

Study Overview

Brief Summary

The first purpose of this study is to investigate the physiological changes of heart failure patients during cardiopulmonary exercise test with spot jogging and compare them with the standard stationary bike cardiopulmonary exercise test. The second one is to compare the effect between home-based cardiac rehabilitation using different step frequency and toe lift or not to adjust spot jogging intensity and outpatient center-based cardiac rehabilitation for heart failure patients.

Detailed Description

This is a pilot, prospective, randomized controlled trial design. We will recruit 40 heart failure patients aged over 18 year-old who have completed stationary bike cardiopulmonary exercise test and was referred to phase II cardiac rehabilitation. After providing informed consent, participants will be randomly assigned to either the home-based cardiac rehabilitation group or the outpatient center-based cardiac rehabilitation group. All participants will undergo spot jogging cardiopulmonary exercise test and six-minute walking test. The home-based spot jogging cardiac rehabilitation group will receive exercise intensity guidance in the outpatient cardiac rehabilitation room for 30 minutes of spot jogging and treadmill exercise during the first, fourth, and seventh weeks, and will perform spot jogging for 30 minutes twice a week at home. The outpatient center-based cardiac rehabilitation group will perform stationary bike or treadmill exercise for 30 minutes twice a week in the outpatient cardiac rehabilitation room. Both groups will achieve their target heart rate or 13 in rating perceived exertion. After 18 exercise sessions, participants will undergo stationary bike exercise test and six-minute walking test again.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Heart failure patients aged over 18 year-old who have completed stationary bike cardiopulmonary exercise test and was referred to phase II cardiac rehabilitation.

Exclusion Criteria

  • Atrial fibrillation
  • Other neurological or musculoskeletal issues that affect physical activity.
  • Undergoing dialysis.
  • Having a pacemaker.
  • Unable to cooperate in completing cardiopulmonary exercise testing.
  • Do not agree to participate in the trial.

Arms & Interventions

home-based cardiac rehabilitation group

Experimental

All participants will undergo spot jogging cardiopulmonary exercise test and six-minute walking test. The home-based spot jogging cardiac rehabilitation group will receive exercise intensity guidance in the outpatient cardiac rehabilitation room for 30 minutes of spot jogging and treadmill exercise during the first, fourth, and seventh weeks, and will perform moderate-intensity spot jogging for 30 minutes twice a week at home.

Intervention: Home-based spot jogging (Other)

outpatient center-based cardiac rehabilitation group

Active Comparator

All participants will undergo spot jogging cardiopulmonary exercise test and six-minute walking test. The outpatient center-based cardiac rehabilitation group will perform moderate-intensity stationary bike or treadmill exercise for 30 minutes twice a week in the outpatient cardiac rehabilitation room.

Intervention: Center-based exercise training (Other)

Outcomes

Primary Outcomes

Cardiopulmonary exercise test

Time Frame: baseline at enrollment and the end of treatment at 9 weeks (after 18 exercise sessions)

Secondary Outcomes

  • Six-minute walking test(baseline at enrollment and the end of treatment at 9 weeks (after 18 exercise sessions))
  • 36-Item Short Form Health Survey(baseline at enrollment and the end of treatment at 9 weeks (after 18 exercise sessions))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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