An interventional study of Muti-model exercise intervention and Disease and exercise suggestion in Heart Failure, sponsored by National Cheng Kung University. Status unknown at 1 site in Taiwan. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-05-17.
Sponsored by National Cheng Kung University · Not applicable, Interventional, and Supportive care
Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in diabetes mellitus with heart failure.
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.
5,801 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's planned enrollment of 80 is above the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →National Cheng Kung University is the lead sponsor of 63 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
The intervention group will receive multi-model exercise intervention 2-3 times per week for 3 months.
Behavioral: Muti-model exercise intervention
The Usual care group will receive heart failure disease and exercise-related education.
Behavioral: Disease and exercise suggestion
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.
The participants will be provided by educational program about heart failure self-care and home-based exercise approach.
NT-proBNP
N-terminal pro-brain natriuretic peptide
Time frame: Change from baseline (0 week) to mid-intervention (6 weeks)
NT-proBNP
N-terminal pro-brain natriuretic peptide
Time frame: Change from baseline (0 week) to post-intervention (12 weeks)
NT-proBNP
N-terminal pro-brain natriuretic peptide
Time frame: Change from baseline (0 week) to follow up (24 weeks)
Oxygen consumption (VO2)
Oxygen consumption examined by cardiopulmonary exercise test
Time frame: Change from baseline (0 week) to mid-intervention (6 weeks)
Oxygen consumption (VO2)
Oxygen consumption examined by cardiopulmonary exercise test
Time frame: Change from baseline (0 week) to post-intervention (12 weeks)
Oxygen consumption (VO2)
Oxygen consumption examined by cardiopulmonary exercise test
Time frame: Change from baseline (0 week) to follow up (24 weeks)
Quality of life score (Minnesota Living With Heart Failure Questionnaire)
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)
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)
Heart Failure Questionnaire
Time frame: Change from baseline (0 week) to follow up (24 weeks)
FEV1/FVC
Pulmonary function test
Time frame: Change from baseline (0 week) to mid-intervention (6 weeks)
FEV1/FVC
Pulmonary function test
Time frame: Change from baseline (0 week) to post-intervention (12 weeks)
FEV1/FVC
Pulmonary function test
Time frame: Change from baseline (0 week) to follow up (24 weeks)
MIP (maximal inspiratory pressure)
Inspiratory muscle function assessed by pressure meter
Time frame: Change from baseline (0 week) to mid-intervention (6 weeks)
MIP (maximal inspiratory pressure)
Inspiratory muscle function assessed by pressure meter
Time frame: Change from baseline (0 week) to post-intervention (12 weeks)
MIP (maximal inspiratory pressure)
Inspiratory muscle function assessed by pressure meter
Time frame: Change from baseline (0 week) to follow up (24 weeks)
MEP (maximal exspiratory pressure)
Inspiratory muscle function assessed by pressure meter
Time frame: Change from baseline (0 week) to mid-intervention (6 weeks)
MEP (maximal exspiratory pressure)
Inspiratory muscle function assessed by pressure meter
Time frame: Change from baseline (0 week) to post-intervention (12 weeks)
MEP (maximal exspiratory pressure)
Inspiratory muscle function assessed by pressure meter
Time frame: Change from baseline (0 week) to follow up (24 weeks)
Plan to share: No — IPD sharing plan will be decided after summarized data being published.
No publications or documents are linked to this record.
Started Apr 2021 (actual). Primary completion is estimated for Dec 2024, 44 months after the start.
Of 1,018 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 44 months is above that.
Counting every sponsor, half of 1,220 studies reached it within 31 months; a quarter within 16 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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National Cheng Kung University