Heart FailureNCT03245125
HIIT Improves Survival of Heart Failure Patients
An observational study of Heart Failure and Cardiac Rehabilitation, run by Chang Gung Memorial Hospital.
Trial summary
BACKGROUND Global burdens of heart failure (HF) are increasing in modern societies. High-intensity interval training (HIIT) increases peak oxygen consumption (VO2peak) in HF patients, which was hypothesized to improve the survival of HF patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Heart Failure, Cardiac Rehabilitation, Cardiac Remodeling, Ventricular
- What is being tested?
- High-intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 329 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 30 Apr 2017
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Baseline information of all eligible candidates, including age, gender, body mass index (BMI), and disease duration were recorded. Serum low-density lipoprotein (LDL), creatinine (Cre), high sensitivity C-reactive protein (hs-CRP), glycohemoglobin (Hba1c), and b-type natriuretic peptide (BNP) were evaluated during the follow-up. Each blood sampling for BNP analysis and short form-36 health survey (SF-36) of physical component score (PCS) and mental component score (MCS) for qualities of life were performed just before each cardiopulmonary exercise test and echocardiographic examination.
Who may be able to join
- From January 1st, 2009 to December 31st, 2016, HF patients, defined according to the European society of cardiology, with stable clinical status greater than 4 weeks after optimal treatment were enrolled in the study.
Who cannot join
- Those, who were ≥ 80 years and < 20 years, unable to perform exercise caused by other non-cardiac disease, pregnant, future cardiac transplantation within 6 months, uncompensated HF patients, pacemaker patients, and renal patients with estimated glomerular filtration rate < 30 ml/min/1.73m2, were not candidates in the study. Patients had absolute contraindications for cardiopulmonary exercise test (CPET) and aerobic activities, suggested by the American College of Sports Medicine (ACSM), were also excluded in the study.
About this study
Official title: Impacts of High-intensity Interval Training on Long-term Survival of Heart Failure Patients
BACKGROUND Global burdens of heart failure (HF) are increasing in modern societies. High-intensity interval training (HIIT) increases peak oxygen consumption (VO2peak) in HF patients, which was hypothesized to improve the survival of HF patients.
OBJECTIVES The cohort study aimed to highlight the effect of HIIT on long-term survivals of HF patients.
METHODS 329 HF patients, enrolled between 2009 and 2016, received multidisciplinary disease management program (MDP). They had cardiopulmonary exercise test for peak exercise capacity (VO2peak), echocardiographic examination for left ventricular ejection fraction (LVEF), LV end-diastolic diameter (LVEDD), and LV end-systolic diameter (LVESD), b-type natriuretic peptide (BNP), and quality of life questionnaire. HF patients with LVEF≤ 40% (HFrEF) and HF patients with LVEF> 40% (HFpEF) underwent≥ 36 times of HIIT. HFrEF and HFpEF patients were classified as the MDP group. Generalized estimating equation (GEE) was used to estimate the interaction between time and VO2peak, LVEF, LVEDD, LVESD, and BNP during the follow-up. Survival analysis was conducted to assess effects of HIIT on the long-term survival of HF during at end of the study.
- Being tested
- High-intensity interval training
- Medical subject headings
- Heart Failure, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingBehavioural
Patients warmed up for 3 min at 30% of peak oxygen consumption (VO2peak). Five 3-minute intervals at 80% of VO2peak and each interval was separated by 3-minute exercise at 40% of VO2peak. The exercise session was terminated by 3-minute cool-down at 30% of VO2peak. All subjects used a EKG and BP monitors as indicators of the assigned exercise intensity. Borg 6-to-20 scale was used to assess the rate of perceived exertion during and after each exercise session. Patients suffering unstable hemodynamic, ischemic cardiac symptoms/signs, and uncontrolled arrhythmia were instructed to immediately terminate exercise training.
| Study group | Role | What they receive |
|---|---|---|
| HIIT subjects in HFrEF patients | heart failure patients with reduced ejection fraction (HFrEF) received at least 36 times of high-intensity interval training (HIIT) Receives: Behavioral: High-intensity interval training | |
| MDP subjects in HFrEF patients | heart failure patients with reduced ejection fraction (HFrEF) received only multidisciplinary disease management program (MDP) and underwent less than 36 times of high-intensity interval training (HIIT) or no exercise training Receives: Behavioral: High-intensity interval training | |
| HIIT subjects in HFpEF patients | heart failure patients with preserved ejection fraction (HFpEF) received at least 36 times of high-intensity interval training (HIIT) Receives: Behavioral: High-intensity interval training | |
| MDP subjects in HFpEF patients | heart failure patients with preserved ejection fraction (HFpEF) received only multidisciplinary disease management program (MDP) and underwent less than 36 times of high-intensity interval training (HIIT) or no exercise training Receives: Behavioral: High-intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause death
Any mortality during the study period
Measured: 2009/1/1 to 2016/12/31
all-cause re-admission
Any re-admission during the study period
Measured: 2009/1/1 to 2016/12/31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start1 Jan 2009
- Primary completion31 Dec 2016
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 329 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chih-Chin Hsu, MD, PhD, Principal investigator, Dept. of PM&R, Keelung Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245125
- Sponsor's protocol ID
- 201601068B0
- Status last verified
- Aug 2017
- First submitted
- 8 Aug 2017
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fu TC, Wang CH, Lin PS, Hsu CC, Cherng WJ, Huang SC, Liu MH, Chiang CL, Wang JS. Aerobic interval training improves oxygen uptake efficiency by enhancing cerebral and muscular hemodynamics in patients with heart failure. Int J Cardiol. 2013 Jul 15;167(1):41-50. doi: 10.1016/j.ijcard.2011.11.086. Epub 2011 Dec 22.
PubMed 22197120Lee MF, Chen WS, Fu TC, Liu MH, Wang JS, Hsu CC, Huang YY, Cherng WJ, Wang CH. Non-invasive cardiac index monitoring during cardiopulmonary functional testing provides additional prognostic value in patients after acute heart failure. Int Heart J. 2012;53(6):364-9. doi: 10.1536/ihj.53.364.
PubMed 23258137
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of High-intensity Interval Training on Long-term Survival of Heart Failure Patients
- ClinicalTrials.gov ID
- NCT03245125
- Acronym / sponsor ID
- 201601068B0
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 10 Aug 2017 (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.
BACKGROUND Global burdens of heart failure (HF) are increasing in modern societies. High-intensity interval training (HIIT) increases peak oxygen consumption (VO2peak) in HF patients, which was hypothesized to improve the survival of HF patients.
OBJECTIVES The cohort study aimed to highlight the effect of HIIT on long-term survivals of HF patients.
METHODS 329 HF patients, enrolled between 2009 and 2016, received multidisciplinary disease management program (MDP). They had cardiopulmonary exercise test for peak exercise capacity (VO2peak), echocardiographic examination for left ventricular ejection fraction (LVEF), LV end-diastolic diameter (LVEDD), and LV end-systolic diameter (LVESD), b-type natriuretic peptide (BNP), and quality of life questionnaire. HF patients with LVEF≤ 40% (HFrEF) and HF patients with LVEF> 40% (HFpEF) underwent≥ 36 times of HIIT. HFrEF and HFpEF patients were classified as the MDP group. Generalized estimating equation (GEE) was used to estimate the interaction between time and VO2peak, LVEF, LVEDD, LVESD, and BNP during the follow-up. Survival analysis was conducted to assess effects of HIIT on the long-term survival of HF during at end of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIIT subjects in HFrEF patients | – | Behavioral: High-intensity interval trainingheart failure patients with reduced ejection fraction (HFrEF) received at least 36 times of high-intensity interval training (HIIT) |
| MDP subjects in HFrEF patients | – | Behavioral: High-intensity interval trainingheart failure patients with reduced ejection fraction (HFrEF) received only multidisciplinary disease management program (MDP) and underwent less than 36 times of high-intensity interval training (HIIT) or no exercise training |
| HIIT subjects in HFpEF patients | – | Behavioral: High-intensity interval trainingheart failure patients with preserved ejection fraction (HFpEF) received at least 36 times of high-intensity interval training (HIIT) |
| MDP subjects in HFpEF patients | – | Behavioral: High-intensity interval trainingheart failure patients with preserved ejection fraction (HFpEF) received only multidisciplinary disease management program (MDP) and underwent less than 36 times of high-intensity interval training (HIIT) or no exercise training |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Baseline information of all eligible candidates, including age, gender, body mass index (BMI), and disease duration were recorded. Serum low-density lipoprotein (LDL), creatinine (Cre), high sensitivity C-reactive protein (hs-CRP), glycohemoglobin (Hba1c), and b-type natriuretic peptide (BNP) were evaluated during the follow-up. Each blood sampling for BNP analysis and short form-36 health survey (SF-36) of physical component score (PCS) and mental component score (MCS) for qualities of life were performed just before each cardiopulmonary exercise test and echocardiographic examination.
Key inclusion criteria (1 listed)
- From January 1st, 2009 to December 31st, 2016, HF patients, defined according to the European society of cardiology, with stable clinical status greater than 4 weeks after optimal treatment were enrolled in the study.
Key exclusion criteria (1 listed)
- Those, who were ≥ 80 years and < 20 years, unable to perform exercise caused by other non-cardiac disease, pregnant, future cardiac transplantation within 6 months, uncompensated HF patients, pacemaker patients, and renal patients with estimated glomerular filtration rate < 30 ml/min/1.73m2, were not candidates in the study. Patients had absolute contraindications for cardiopulmonary exercise test (CPET) and aerobic activities, suggested by the American College of Sports Medicine (ACSM), were also excluded in the study.
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 |
|---|---|---|
| High-intensity interval trainingPatients warmed up for 3 min at 30% of peak oxygen consumption (VO2peak). Five 3-minute intervals at 80% of VO2peak and each interval was separated by 3-minute exercise at 40% of VO2peak. The exercise session was terminated by 3-minute cool-down at 30% of VO2peak. All subjects used a EKG and BP monitors as indicators of the assigned exercise intensity. Borg 6-to-20 scale was used to assess the rate of perceived exertion during and after each exercise session. Patients suffering unstable hemodynamic, ischemic cardiac symptoms/signs, and uncontrolled arrhythmia were instructed to immediately terminate exercise training. | Behavioural | HIIT subjects in HFpEF patients, HIIT subjects in HFrEF patients, MDP subjects in HFpEF patients, MDP subjects in HFrEF patients |
Primary outcome
all-cause death
Time frame: 2009/1/1 to 2016/12/31
Any mortality during the study period
all-cause re-admission
Time frame: 2009/1/1 to 2016/12/31
Any re-admission during the study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Results publication: PubMed 22197120Fu TC, Wang CH, Lin PS, Hsu CC, Cherng WJ, Huang SC, Liu MH, Chiang CL, Wang JS. Aerobic interval training improves oxygen uptake efficiency by enhancing cerebral and muscular hemodynamics in patients with heart failure. Int J Cardiol. 2013 Jul 15;167(1):41-50. doi: 10.1016/j.ijcard.2011.11.086. Epub 2011 Dec 22.
- Results publication: PubMed 23258137Lee MF, Chen WS, Fu TC, Liu MH, Wang JS, Hsu CC, Huang YY, Cherng WJ, Wang CH. Non-invasive cardiac index monitoring during cardiopulmonary functional testing provides additional prognostic value in patients after acute heart failure. Int Heart J. 2012;53(6):364-9. doi: 10.1536/ihj.53.364.
- Individual participant dataSharing planned: Undecided
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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.
Chih-Chin Hsu, MD, PhD principal investigator
Dept. of PM&R, Keelung Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cardiac Rehabilitation, run by Chang Gung Memorial Hospital.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause death (time frame: 2009/1/1 to 2016/12/31). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03245125, which also lists 2 linked publications.
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 10 Aug 2017.