NCT06756659

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
2mo left

Started Feb 2025

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Feb 2025Jun 2026

First Submitted

Initial submission to the registry

December 8, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

February 5, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

December 8, 2024

Last Update Submit

March 17, 2026

Conditions

Keywords

HFCR

Outcome Measures

Primary Outcomes (1)

  • Cardiopulmonary exercise test

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

Secondary Outcomes (2)

  • 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)

Study Arms (2)

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.

Other: Home-based spot jogging

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.

Other: Center-based exercise training

Interventions

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

outpatient center-based cardiac rehabilitation group

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. They will then perform moderate-intensity spot jogging at home for 30 minutes, twice a week, at a perceived exertion level of 13 out of 20 on the RPE scale.

home-based cardiac rehabilitation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2024

First Posted

January 3, 2025

Study Start

February 5, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations