Clinical trial NCT06756659: Home-based Cardiac Rehabilitation With Spot-jogging
Official title: Comparison of the Effectiveness Between Home-based Cardiac Rehabilitation With Spot-jogging and Outpatient Center-Based Cardiac Rehabilitation in Patients With Heart Failure.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Cardiac Rehabilitation
Keywords: HF
CR
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cardiopulmonary exercise test
timeFrame: baseline at enrollment and the end of treatment at 9 weeks (after 18 exercise sessions)
Secondary outcomes:
measure: Six-minute walking test
timeFrame: baseline at enrollment and the end of treatment at 9 weeks (after 18 exercise sessions)
measure: 36-Item Short Form Health Survey
timeFrame: baseline at enrollment and the end of treatment at 9 weeks (after 18 exercise sessions)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
citation: Ikenaga M, Yamada Y, Kose Y, Morimura K, Higaki Y, Kiyonaga A, Tanaka H; Nakagawa Study Group. Effects of a 12-week, short-interval, intermittent, low-intensity, slow-jogging program on skeletal muscle, fat infiltration, and fitness in older adults: randomized controlled trial. Eur J Appl Physiol. 2017 Jan;117(1):7-15. doi: 10.1007/s00421-016-3493-9. Epub 2016 Nov 15.