Heart FailureNCT04888390
Exercise Intervention on Cardiorespiratory Function in HF With DM.
A study testing Muti-model exercise intervention and Disease and exercise suggestion in people with Heart Failure, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in diabetes mellitus with heart failure. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Muti-model exercise intervention and Disease and exercise suggestion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Apr 2021to 31 Dec 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart Failure (NYHA I-III) with diabetes mellitus
- Aged 30-85
- Mini-mental state examination score > 25
Who cannot join
- eGFR < 30mL/min/1.73m2
- Exercise intervention contraindication of heart failure
- Pregnancy
- Uncontrolled disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University
Tainan, 701
kun-Ling Tsai, Ph.D., 886-6-2353535 ext. 6219, kunlingtsai@mail.ncku.edu.tw
Hsin-Lun Yang, M.S., 886-6-2353535 ext. 5078, t66064043@pt.ncku.edu.tw
About this study
Official title: The Effect of Exercise Intervention on Cardiorespiratory Function and Exercise Capacity in Heart Failure Patients With Diabetes Mellitus.
Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in diabetes mellitus with heart failure.
Read the detailed description
This research intends to explore the effects of exercise training on the cardiopulmonary function and exercise tolerance of heart failure patients with diabetes mellitus. In addition to the impaired cardiac function, the clinical manifestations of patients with heart failure also shown the inefficiency of pulmonary function, peripheral vascular function, and musculoskeletal system. Due to low exercise tolerance, functional activities and quality of life are impaired. With the high hospitalization rate and high mortality rate, the clinical treatment of heart failure is challenging. At present, exercise has been listed in the guidelines for the treatment of heart failure, and is recommended that patients with heart failure should take regular aerobic exercise training to maintain functional activity and reduce symptoms. Past studies have also suggested that exercise training can help reduce the risk factors of cardiovascular disease and improve part of the cardiovascular function. Furthermore, exercise can improve the quality of life and reduce the hospitalization rate. Although diabetes is a common comorbidity of heart failure, and is a poor prognostic factor that increases the overall risk of heart failure and cardiovascular death, there are few studies in the past to further explore the benefits of exercise training for diabetes with heart failure, although current studies have confirmed that regular exercise can effectively control diabetes. However, the cardiopulmonary function and exercise tolerance of exercise training for diabetes with heart failure still need to be clarified. Therefore, this study aims to investigated the effect of cardiopulmonary function and exercise tolerance in patients with heart failure. The study participants were divided into two groups: usual care group and exercise group. Exercise training involved last for twelve weeks, and then follow up until the sixth week after exercise training. The results of the study are expected to be applied to clinical heart failure rehabilitation. It is expected that through active cardiopulmonary rehabilitation combined with precise and personalized exercise prescriptions, it will prevent deterioration of heart failure and may help improve the clinical practice of heart failure.
- Conditions
- Heart Failure
- Being tested
- Muti-model exercise intervention, Disease and exercise suggestion
- Keywords
- Heart failure, Diabetes mellitus, Exercise intervention, Cardiac rehabilitation
- Medical subject headings
- Heart Failure, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muti-model exercise interventionBehavioural
The Muti-model exercise intervention include aerobic exercise training by ergometer or treadmill, resistance exercise by using elastic band and flexibility exercise by active stretch. The total training program takes for 60 minutes, 2-3 times per week for 3 months.
Disease and exercise suggestionBehavioural
The participants will be provided by educational program about heart failure self-care and home-based exercise approach.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive multi-model exercise intervention 2-3 times per week for 3 months. Receives: Behavioral: Muti-model exercise intervention |
| Usual care group | Active comparator | The Usual care group will receive heart failure disease and exercise-related education. Receives: Behavioral: Disease and exercise suggestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
NT-proBNP
N-terminal pro-brain natriuretic peptide
Measured: Change from baseline (0 week) to mid-intervention (6 weeks)
NT-proBNP
N-terminal pro-brain natriuretic peptide
Measured: Change from baseline (0 week) to post-intervention (12 weeks)
NT-proBNP
N-terminal pro-brain natriuretic peptide
Measured: Change from baseline (0 week) to follow up (24 weeks)
Oxygen consumption (VO2)
Oxygen consumption examined by cardiopulmonary exercise test
Measured: Change from baseline (0 week) to mid-intervention (6 weeks)
Oxygen consumption (VO2)
Oxygen consumption examined by cardiopulmonary exercise test
Measured: Change from baseline (0 week) to post-intervention (12 weeks)
Oxygen consumption (VO2)
Oxygen consumption examined by cardiopulmonary exercise test
Measured: Change from baseline (0 week) to follow up (24 weeks)
Secondary outcomes (12)
Quality of life score (Minnesota Living With Heart Failure Questionnaire)
Heart Failure Questionnaire
Measured: Change from baseline (0 week) to mid-intervention (6 weeks)
Quality of life score (Minnesota Living With Heart Failure Questionnaire)
Heart Failure Questionnaire
Measured: Change from baseline (0 week) to post-intervention (12 weeks)
Quality of life score (Minnesota Living With Heart Failure Questionnaire)
Heart Failure Questionnaire
Measured: Change from baseline (0 week) to follow up (24 weeks)
FEV1/FVC
Pulmonary function test
Measured: Change from baseline (0 week) to mid-intervention (6 weeks)
FEV1/FVC
Pulmonary function test
Measured: Change from baseline (0 week) to post-intervention (12 weeks)
FEV1/FVC
Pulmonary function test
Measured: Change from baseline (0 week) to follow up (24 weeks)
MIP (maximal inspiratory pressure)
Inspiratory muscle function assessed by pressure meter
Measured: Change from baseline (0 week) to mid-intervention (6 weeks)
MIP (maximal inspiratory pressure)
Inspiratory muscle function assessed by pressure meter
Measured: Change from baseline (0 week) to post-intervention (12 weeks)
MIP (maximal inspiratory pressure)
Inspiratory muscle function assessed by pressure meter
Measured: Change from baseline (0 week) to follow up (24 weeks)
MEP (maximal exspiratory pressure)
Inspiratory muscle function assessed by pressure meter
Measured: Change from baseline (0 week) to mid-intervention (6 weeks)
MEP (maximal exspiratory pressure)
Inspiratory muscle function assessed by pressure meter
Measured: Change from baseline (0 week) to post-intervention (12 weeks)
MEP (maximal exspiratory pressure)
Inspiratory muscle function assessed by pressure meter
Measured: Change from baseline (0 week) to follow up (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start20 Apr 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study population will be randomized and separated in two groups, Intervention and Usual care group.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun-Ling Tsai, National Cheng Kung University
- Investigators
- Kun-Ling Tsai, Ph.D., Principal investigator, Department of Physical Therapy, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888390
- Sponsor's protocol ID
- B-BR-110-016
- Status last verified
- May 2021
- First submitted
- 5 May 2021
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing plan will be decided after summarized data being published.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise Intervention on Cardiorespiratory Function and Exercise Capacity in Heart Failure Patients With Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT04888390
- Acronym / sponsor ID
- B-BR-110-016
- Conditions
- Heart Failure
- Keywords
- Heart failure, Diabetes mellitus, Exercise intervention, Cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 May 2021 (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.
Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in diabetes mellitus with heart failure.
Detailed description
This research intends to explore the effects of exercise training on the cardiopulmonary function and exercise tolerance of heart failure patients with diabetes mellitus. In addition to the impaired cardiac function, the clinical manifestations of patients with heart failure also shown the inefficiency of pulmonary function, peripheral vascular function, and musculoskeletal system. Due to low exercise tolerance, functional activities and quality of life are impaired. With the high hospitalization rate and high mortality rate, the clinical treatment of heart failure is challenging. At present, exercise has been listed in the guidelines for the treatment of heart failure, and is recommended that patients with heart failure should take regular aerobic exercise training to maintain functional activity and reduce symptoms. Past studies have also suggested that exercise training can help reduce the risk factors of cardiovascular disease and improve part of the cardiovascular function. Furthermore, exercise can improve the quality of life and reduce the hospitalization rate. Although diabetes is a common comorbidity of heart failure, and is a poor prognostic factor that increases the overall risk of heart failure and cardiovascular death, there are few studies in the past to further explore the benefits of exercise training for diabetes with heart failure, although current studies have confirmed that regular exercise can effectively control diabetes. However, the cardiopulmonary function and exercise tolerance of exercise training for diabetes with heart failure still need to be clarified. Therefore, this study aims to investigated the effect of cardiopulmonary function and exercise tolerance in patients with heart failure. The study participants were divided into two groups: usual care group and exercise group. Exercise training involved last for twelve weeks, and then follow up until the sixth week after exercise training. The results of the study are expected to be applied to clinical heart failure rehabilitation. It is expected that through active cardiopulmonary rehabilitation combined with precise and personalized exercise prescriptions, it will prevent deterioration of heart failure and may help improve the clinical practice of heart failure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study population will be randomized and separated in two groups, Intervention and Usual care group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Muti-model exercise interventionThe intervention group will receive multi-model exercise intervention 2-3 times per week for 3 months. |
| Usual care group | Active comparator | Behavioral: Disease and exercise suggestionThe Usual care group will receive heart failure disease and exercise-related education. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Heart Failure (NYHA I-III) with diabetes mellitus
- Aged 30-85
- Mini-mental state examination score > 25
Key exclusion criteria (4 listed)
- eGFR < 30mL/min/1.73m2
- Exercise intervention contraindication of heart failure
- Pregnancy
- Uncontrolled disease
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 |
|---|---|---|
| Muti-model exercise interventionThe Muti-model exercise intervention include aerobic exercise training by ergometer or treadmill, resistance exercise by using elastic band and flexibility exercise by active stretch. The total training program takes for 60 minutes, 2-3 times per week for 3 months. | Behavioural | Intervention group |
| Disease and exercise suggestionThe participants will be provided by educational program about heart failure self-care and home-based exercise approach. | Behavioural | Usual care group |
Primary outcome
NT-proBNP
Time frame: Change from baseline (0 week) to mid-intervention (6 weeks)
N-terminal pro-brain natriuretic peptide
NT-proBNP
Time frame: Change from baseline (0 week) to post-intervention (12 weeks)
N-terminal pro-brain natriuretic peptide
NT-proBNP
Time frame: Change from baseline (0 week) to follow up (24 weeks)
N-terminal pro-brain natriuretic peptide
Oxygen consumption (VO2)
Time frame: Change from baseline (0 week) to mid-intervention (6 weeks)
Oxygen consumption examined by cardiopulmonary exercise test
Oxygen consumption (VO2)
Time frame: Change from baseline (0 week) to post-intervention (12 weeks)
Oxygen consumption examined by cardiopulmonary exercise test
Oxygen consumption (VO2)
Time frame: Change from baseline (0 week) to follow up (24 weeks)
Oxygen consumption examined by cardiopulmonary exercise test
12 secondary outcomes
Quality of life score (Minnesota Living With Heart Failure Questionnaire)
Time frame: Change from baseline (0 week) to mid-intervention (6 weeks)
Quality of life score (Minnesota Living With Heart Failure Questionnaire)
Time frame: Change from baseline (0 week) to post-intervention (12 weeks)
Quality of life score (Minnesota Living With Heart Failure Questionnaire)
Time frame: Change from baseline (0 week) to follow up (24 weeks)
FEV1/FVC
Time frame: Change from baseline (0 week) to mid-intervention (6 weeks)
FEV1/FVC
Time frame: Change from baseline (0 week) to post-intervention (12 weeks)
FEV1/FVC
Time frame: Change from baseline (0 week) to follow up (24 weeks)
MIP (maximal inspiratory pressure)
Time frame: Change from baseline (0 week) to mid-intervention (6 weeks)
MIP (maximal inspiratory pressure)
Time frame: Change from baseline (0 week) to post-intervention (12 weeks)
MIP (maximal inspiratory pressure)
Time frame: Change from baseline (0 week) to follow up (24 weeks)
MEP (maximal exspiratory pressure)
Time frame: Change from baseline (0 week) to mid-intervention (6 weeks)
MEP (maximal exspiratory pressure)
Time frame: Change from baseline (0 week) to post-intervention (12 weeks)
MEP (maximal exspiratory pressure)
Time frame: Change from baseline (0 week) to follow up (24 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Individual participant dataSharing planned: No. IPD sharing plan will be decided after summarized data being published.
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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.
Kun-Ling Tsai, Ph.D. principal investigator
Department of Physical Therapy, National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muti-model exercise intervention and Disease and exercise suggestion in people with Heart Failure, run by National Cheng Kung University at 1 site in Taiwan.
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 3 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 17 May 2021. 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 Taiwan. 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. 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 Kun-Ling Tsai, Ph.D. (886-6-2353535 ext. 6219, kunlingtsai@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NT-proBNP (time frame: Change from baseline (0 week) to mid-intervention (6 weeks)). The study lists 6 primary outcomes in all. 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 17 May 2021.