Exercise Intervention on Cardiorespiratory Function in HF With DM.

National Cheng Kung University

Status: Enrolling

Conditions: Heart Failure

Treatments: Behavioral: Disease and exercise suggestion; Behavioral: Muti-model exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04888390

B-BR-110-016

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Intervention group

Experimental group

Description:

The intervention group will receive multi-model exercise intervention 2-3 times per week for 3 months.

Treatment:

Behavioral: Muti-model exercise intervention

Usual care group

Active Comparator group

Description:

The Usual care group will receive heart failure disease and exercise-related education.

Treatment:

Behavioral: Disease and exercise suggestion