Clinical trial NCT04888390: Exercise Intervention on Cardiorespiratory Function in HF With DM.
Official title: The Effect of Exercise Intervention on Cardiorespiratory Function and Exercise Capacity in Heart Failure Patients With Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Diabetes mellitus
Exercise intervention
Cardiac rehabilitation
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study population will be randomized and separated in two groups, Intervention and Usual care group.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: NT-proBNP
timeFrame: Change from baseline (0 week) to mid-intervention (6 weeks)
measure: NT-proBNP
timeFrame: Change from baseline (0 week) to post-intervention (12 weeks)
measure: NT-proBNP
timeFrame: Change from baseline (0 week) to follow up (24 weeks)
measure: Oxygen consumption (VO2)
timeFrame: Change from baseline (0 week) to mid-intervention (6 weeks)
measure: Oxygen consumption (VO2)
timeFrame: Change from baseline (0 week) to post-intervention (12 weeks)
measure: Oxygen consumption (VO2)
timeFrame: Change from baseline (0 week) to follow up (24 weeks)
Secondary outcomes:
measure: Quality of life score (Minnesota Living With Heart Failure Questionnaire)
timeFrame: Change from baseline (0 week) to mid-intervention (6 weeks)
measure: Quality of life score (Minnesota Living With Heart Failure Questionnaire)
timeFrame: Change from baseline (0 week) to post-intervention (12 weeks)
measure: Quality of life score (Minnesota Living With Heart Failure Questionnaire)
timeFrame: Change from baseline (0 week) to follow up (24 weeks)
measure: FEV1/FVC
timeFrame: Change from baseline (0 week) to mid-intervention (6 weeks)
measure: FEV1/FVC
timeFrame: Change from baseline (0 week) to post-intervention (12 weeks)
measure: FEV1/FVC
timeFrame: Change from baseline (0 week) to follow up (24 weeks)
measure: MIP (maximal inspiratory pressure)
timeFrame: Change from baseline (0 week) to mid-intervention (6 weeks)
measure: MIP (maximal inspiratory pressure)
timeFrame: Change from baseline (0 week) to post-intervention (12 weeks)
measure: MIP (maximal inspiratory pressure)
timeFrame: Change from baseline (0 week) to follow up (24 weeks)
measure: MEP (maximal exspiratory pressure)
timeFrame: Change from baseline (0 week) to mid-intervention (6 weeks)
measure: MEP (maximal exspiratory pressure)
timeFrame: Change from baseline (0 week) to post-intervention (12 weeks)
measure: MEP (maximal exspiratory pressure)
timeFrame: Change from baseline (0 week) to follow up (24 weeks)
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: Department of Physical Therapy, National Cheng Kung University
name: Kun-Ling Tsai, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: