Heart Failure
Conditions
Keywords
Heart failure, Diabetes mellitus, Exercise intervention, Cardiac rehabilitation
Brief summary
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.
Interventions
BEHAVIORALMuti-model exercise intervention
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.
BEHAVIORALDisease and exercise suggestion
The participants will be provided by educational program about heart failure self-care and home-based exercise approach.
Sponsors
National Cheng Kung University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The study population will be randomized and separated in two groups, Intervention and Usual care group.
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Heart Failure (NYHA I-III) with diabetes mellitus * Aged 30-85 * Mini-mental state examination score \> 25
Exclusion criteria
* eGFR \< 30mL/min/1.73m2 * Exercise intervention contraindication of heart failure * Pregnancy * Uncontrolled disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NT-proBNP | Change from baseline (0 week) to mid-intervention (6 weeks) | N-terminal pro-brain natriuretic peptide |
| Oxygen consumption (VO2) | Change from baseline (0 week) to mid-intervention (6 weeks) | Oxygen consumption examined by cardiopulmonary exercise test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life score (Minnesota Living With Heart Failure Questionnaire) | Change from baseline (0 week) to mid-intervention (6 weeks) | Heart Failure Questionnaire |
| FEV1/FVC | Change from baseline (0 week) to mid-intervention (6 weeks) | Pulmonary function test |
| MIP (maximal inspiratory pressure) | Change from baseline (0 week) to mid-intervention (6 weeks) | Inspiratory muscle function assessed by pressure meter |
| MEP (maximal exspiratory pressure) | Change from baseline (0 week) to mid-intervention (6 weeks) | Inspiratory muscle function assessed by pressure meter |
Countries
Taiwan
Contacts
Primary ContactKun-Ling Tsai, Ph.D.
Backup ContactHsin-Lun Yang, M.S.
Outcome results
None listed