Chronic Heart FailureNCT05659420
High Intensity Interval Training in Chronic Heart Failure
A study testing Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor in people with Chronic Heart Failure and Cardiac Rehabilitation, run by Inha University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Chronic Heart Failure, Cardiac Rehabilitation
- What is being tested?
- Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- contraindication to cardiopulmonary exercise test
- musculoskeletal problem who cannot perform cardiopulmonary exercise test
- cognition deficit who cannot understand directions
- severe medial illness
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Inha University hospital
Incheon, Gyeonggi-do, 07980
Kyung-Lim Joa, M.D., +82-10-9111-9432, drjoakl@gmail.com
About this study
Official title: The Effect of High-intensity Interval Training and Moderate Intensity Continuous Training on Cardiopulmonary Functions in Chronic Heart Failure
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.
Read the 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
- Conditions
- Chronic Heart Failure, Cardiac Rehabilitation
- Being tested
- Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitorBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval training | Experimental | Not described Receives: 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 | Not described Receives: Behavioral: Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor |
| Control | Placebo comparator | Not described Receives: Behavioral: Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal or peak oxygen consumption (VO2max or VO2peak, same meaning) (kg/ml/min)
at the end of training, from baseline to 12 weeks
Measured: compare baseline data with 12 weeks rehabilitation data
Secondary outcomes (11)
Anaerobic threshold (kg/ml/min)
The anaerobic threshold is the highest exercise intensity that you can sustain for a prolonged period without lactate substantially building up in your blood.
Measured: compare baseline data with 12 weeks rehabilitation data
6minute walk test (meter)
Measured: compare baseline data with 12 weeks rehabilitation data
maximal heart rate (bpm)
Measured: compare baseline data with 12 weeks rehabilitation data
systolic blood pressure (mmHg)
Measured: compare baseline data with 12 weeks rehabilitation data
diastolic blood pressure (mmHg)
Measured: compare baseline data with 12 weeks rehabilitation data
resting heart rate (bpm)
Measured: compare baseline data with 12 weeks rehabilitation data
diastolic blood presure (mmHg)
Measured: compare baseline data with 12 weeks rehabilitation data
depression scale by Patient Health Questionnaire
Patient Health Questionnaire (PHQ; range, 0-27; higher score = severe depression; cut-off score of 5 for minimal depression)
Measured: compare baseline data with 12 weeks rehabilitation data
anxiety scale by Generalized Anxiety Disorder Scale
Generalized Anxiety Disorder Scale (GAD; range, 0-21; higher score = severe anxiety; cut-off score of 5 for mild anxiety)
Measured: compare baseline data with 12 weeks rehabilitation data
fatigue scale by fatigue severity scale
fatigue severity scale (FSS; range, 9-63; higher score = severe fatigue; cut-off score of 4 for fatigue)
Measured: compare baseline data with 12 weeks rehabilitation data
Quality of Life (QoL) questionnaire (MacNew)
MacNew QoL questionnaire is a measurement tool for patients with cardiac disease that measures physical, emotional, and social functional levels to provide overall QoL.
Measured: compare baseline data with 12 weeks rehabilitation data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Jan 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joa KyungLim, Inha University Hospital
- Investigators
- Kyung-Lim Joa, M.D., Principal investigator, Department of physical medicine and rehabilitation, Inha University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659420
- Sponsor's protocol ID
- InhaUH
- Status last verified
- Feb 2023
- First submitted
- 5 Dec 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-intensity Interval Training and Moderate Intensity Continuous Training on Cardiopulmonary Functions in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT05659420
- Acronym / sponsor ID
- InhaUH
- Conditions
- Chronic Heart Failure, Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- medically stable chronic heart failure
- NYHA II-III
- can perform cardiopulmonary exercise test
- after 3months with proper medication
- age 30 to 70
Key exclusion criteria (4 listed)
- contraindication to cardiopulmonary exercise test
- musculoskeletal problem who cannot perform cardiopulmonary exercise test
- cognition deficit who cannot understand directions
- severe medial illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitoraerobic 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 | Behavioural | Control, High intensity interval training, Moderate intensity continous training |
Primary outcome
Maximal or peak oxygen consumption (VO2max or VO2peak, same meaning) (kg/ml/min)
Time frame: compare baseline data with 12 weeks rehabilitation data
at the end of training, from baseline to 12 weeks
11 secondary outcomes
Anaerobic threshold (kg/ml/min)
Time frame: compare baseline data with 12 weeks rehabilitation data
6minute walk test (meter)
Time frame: compare baseline data with 12 weeks rehabilitation data
maximal heart rate (bpm)
Time frame: compare baseline data with 12 weeks rehabilitation data
systolic blood pressure (mmHg)
Time frame: compare baseline data with 12 weeks rehabilitation data
diastolic blood pressure (mmHg)
Time frame: compare baseline data with 12 weeks rehabilitation data
resting heart rate (bpm)
Time frame: compare baseline data with 12 weeks rehabilitation data
diastolic blood presure (mmHg)
Time frame: compare baseline data with 12 weeks rehabilitation data
depression scale by Patient Health Questionnaire
Time frame: compare baseline data with 12 weeks rehabilitation data
anxiety scale by Generalized Anxiety Disorder Scale
Time frame: compare baseline data with 12 weeks rehabilitation data
fatigue scale by fatigue severity scale
Time frame: compare baseline data with 12 weeks rehabilitation data
Quality of Life (QoL) questionnaire (MacNew)
Time frame: compare baseline data with 12 weeks rehabilitation data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung-Lim Joa, M.D. principal investigator
Department of physical medicine and rehabilitation, Inha University hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation comprised aerobic exercise on a treadmill accompanied by an electrocardiogram monitoring device and a blood pressure monitor in people with Chronic Heart Failure and Cardiac Rehabilitation, run by Inha University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyung-Lim Joa, M.D. (+82-10-9111-9432, drjoakl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal or peak oxygen consumption (VO2max or VO2peak, same meaning) (kg/ml/min) (time frame: compare baseline data with 12 weeks rehabilitation data). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.