Exercise Intervention on Cardiorespiratory Function in HF With DM.

Study Overview
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Brief Summary
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Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in diabetes mellitus with heart failure.

Detailed Description
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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.

Official Title
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The Effect of Exercise Intervention on Cardiorespiratory Function and Exercise Capacity in Heart Failure Patients With Diabetes Mellitus.

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Muti-model exercise intervention
* Behavioral: Disease and exercise suggestion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study population will be randomized and separated in two groups, Intervention and Usual care group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The intervention group will receive multi-model exercise intervention 2-3 times per week for 3 months. | Behavioral: Muti-model exercise intervention<br>* 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.<br>|
| Active Comparator: Usual care group<br>The Usual care group will receive heart failure disease and exercise-related education. | Behavioral: Disease and exercise suggestion<br>* The participants will be provided by educational program about heart failure self-care and home-based exercise approach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NT-proBNP | N-terminal pro-brain natriuretic peptide | Change from baseline (0 week) to mid-intervention (6 weeks) | 
| NT-proBNP | N-terminal pro-brain natriuretic peptide | Change from baseline (0 week) to post-intervention (12 weeks) | 
| NT-proBNP | N-terminal pro-brain natriuretic peptide | Change from baseline (0 week) to follow up (24 weeks) | 
| Oxygen consumption (VO2) | Oxygen consumption examined by cardiopulmonary exercise test | Change from baseline (0 week) to mid-intervention (6 weeks) | 
| Oxygen consumption (VO2) | Oxygen consumption examined by cardiopulmonary exercise test | Change from baseline (0 week) to post-intervention (12 weeks) | 
| Oxygen consumption (VO2) | Oxygen consumption examined by cardiopulmonary exercise test | Change from baseline (0 week) to follow up (24 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score (Minnesota Living With Heart Failure Questionnaire) | Heart Failure Questionnaire | Change from baseline (0 week) to mid-intervention (6 weeks) | 
| Quality of life score (Minnesota Living With Heart Failure Questionnaire) | Heart Failure Questionnaire | Change from baseline (0 week) to post-intervention (12 weeks) | 
| Quality of life score (Minnesota Living With Heart Failure Questionnaire) | Heart Failure Questionnaire | Change from baseline (0 week) to follow up (24 weeks) | 
| FEV1/FVC | Pulmonary function test | Change from baseline (0 week) to mid-intervention (6 weeks) | 
| FEV1/FVC | Pulmonary function test | Change from baseline (0 week) to post-intervention (12 weeks) | 
| FEV1/FVC | Pulmonary function test | Change from baseline (0 week) to follow up (24 weeks) | 
| MIP (maximal inspiratory pressure) | Inspiratory muscle function assessed by pressure meter | Change from baseline (0 week) to mid-intervention (6 weeks) | 
| MIP (maximal inspiratory pressure) | Inspiratory muscle function assessed by pressure meter | Change from baseline (0 week) to post-intervention (12 weeks) | 
| MIP (maximal inspiratory pressure) | Inspiratory muscle function assessed by pressure meter | Change from baseline (0 week) to follow up (24 weeks) | 
| MEP (maximal exspiratory pressure) | Inspiratory muscle function assessed by pressure meter | Change from baseline (0 week) to mid-intervention (6 weeks) | 
| MEP (maximal exspiratory pressure) | Inspiratory muscle function assessed by pressure meter | Change from baseline (0 week) to post-intervention (12 weeks) | 
| MEP (maximal exspiratory pressure) | Inspiratory muscle function assessed by pressure meter | Change from baseline (0 week) to follow up (24 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Diabetes mellitus, Exercise intervention, Cardiac rehabilitation