NCT05659420

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 5, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

2.6 years

First QC Date

December 5, 2022

Last Update Submit

February 28, 2023

Conditions

Chronic Heart FailureCardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Anaerobic threshold (kg/ml/min)

    compare baseline data with 12 weeks rehabilitation data

  • 6minute walk test (meter)

    compare baseline data with 12 weeks rehabilitation data

  • maximal heart rate (bpm)

    compare baseline data with 12 weeks rehabilitation data

  • systolic blood pressure (mmHg)

    compare baseline data with 12 weeks rehabilitation data

  • diastolic blood pressure (mmHg)

    compare baseline data with 12 weeks rehabilitation data

  • +6 more secondary outcomes

Study Arms (3)

High intensity interval training

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

Moderate intensity continous training

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

Control

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

Interventions

Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitorBEHAVIORAL

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

ControlHigh intensity interval trainingModerate intensity continous training

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • contraindication to cardiopulmonary exercise test
  • musculoskeletal problem who cannot perform cardiopulmonary exercise test
  • cognition deficit who cannot understand directions
  • severe medial illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inha University hospital

Incheon, Gyeonggi-do, 07980, South Korea

RECRUITING

Study Officials

  • Kyung-Lim Joa, M.D.

    Department of physical medicine and rehabilitation, Inha University hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyung-Lim Joa, M.D.

CONTACT

+82-10-9111-9432drjoakl@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor, M.D. Ph.D

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 21, 2022

Study Start

January 1, 2023

Primary Completion

July 31, 2025

Study Completion

December 31, 2025

Last Updated

March 2, 2023

Record last verified: 2023-02

Locations

KR(1)