Exercise Intervention on Cardiorespiratory Function in HF With DM.

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Behavioral: Muti-model exercise intervention; Behavioral: Disease and exercise suggestion

• Registration Number: NCT04888390
• Lead Sponsor: National Cheng Kung University

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.

Study Timeline

• Study Start: 2021-04-20
• Status Verified: 2021-05
• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-11
• Last Update Submitted: 2021-05-11
• Study First Posted: 2021-05-17
• Last Update Posted: 2021-05-17
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Muti-model exercise intervention	The intervention group will receive multi-model exercise intervention 2-3 times per week for 3 months.
Usual care group	Disease and exercise suggestion	The Usual care group will receive heart failure disease and exercise-related education.

Primary Outcome Measures

Name	Time	Method
Oxygen consumption (VO2)	Change from baseline (0 week) to follow up (24 weeks)	Oxygen consumption examined by cardiopulmonary exercise test
NT-proBNP	Change from baseline (0 week) to follow up (24 weeks)	N-terminal pro-brain natriuretic peptide

Secondary Outcome Measures

Name	Time	Method
Quality of life score (Minnesota Living With Heart Failure Questionnaire)	Change from baseline (0 week) to follow up (24 weeks)	Heart Failure Questionnaire
MEP (maximal exspiratory pressure)	Change from baseline (0 week) to follow up (24 weeks)	Inspiratory muscle function assessed by pressure meter
FEV1/FVC	Change from baseline (0 week) to follow up (24 weeks)	Pulmonary function test
MIP (maximal inspiratory pressure)	Change from baseline (0 week) to follow up (24 weeks)	Inspiratory muscle function assessed by pressure meter

Trial Locations

Locations (1)

National Cheng Kung University; 🇨🇳 Tainan, Taiwan