Exercise Intervention on Cardiorespiratory Function in HF With DM.

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04888390
• Other study ID #: B-BR-110-016
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2021
• Source: National Cheng Kung University
• Contact: Kun-Ling Tsai, Ph.D.
• Phone: 886-6-2353535
• Email: kunlingtsai[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Muti-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.
• Disease and exercise suggestion
The participants will be provided by educational program about heart failure self-care and home-based exercise approach.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng Kung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NT-proBNP	N-terminal pro-brain natriuretic peptide	Change from baseline (0 week) to mid-intervention (6 weeks)
Primary	NT-proBNP	N-terminal pro-brain natriuretic peptide	Change from baseline (0 week) to post-intervention (12 weeks)
Primary	NT-proBNP	N-terminal pro-brain natriuretic peptide	Change from baseline (0 week) to follow up (24 weeks)
Primary	Oxygen consumption (VO2)	Oxygen consumption examined by cardiopulmonary exercise test	Change from baseline (0 week) to mid-intervention (6 weeks)
Primary	Oxygen consumption (VO2)	Oxygen consumption examined by cardiopulmonary exercise test	Change from baseline (0 week) to post-intervention (12 weeks)
Primary	Oxygen consumption (VO2)	Oxygen consumption examined by cardiopulmonary exercise test	Change from baseline (0 week) to follow up (24 weeks)
Secondary	Quality of life score (Minnesota Living With Heart Failure Questionnaire)	Heart Failure Questionnaire	Change from baseline (0 week) to mid-intervention (6 weeks)
Secondary	Quality of life score (Minnesota Living With Heart Failure Questionnaire)	Heart Failure Questionnaire	Change from baseline (0 week) to post-intervention (12 weeks)
Secondary	Quality of life score (Minnesota Living With Heart Failure Questionnaire)	Heart Failure Questionnaire	Change from baseline (0 week) to follow up (24 weeks)
Secondary	FEV1/FVC	Pulmonary function test	Change from baseline (0 week) to mid-intervention (6 weeks)
Secondary	FEV1/FVC	Pulmonary function test	Change from baseline (0 week) to post-intervention (12 weeks)
Secondary	FEV1/FVC	Pulmonary function test	Change from baseline (0 week) to follow up (24 weeks)
Secondary	MIP (maximal inspiratory pressure)	Inspiratory muscle function assessed by pressure meter	Change from baseline (0 week) to mid-intervention (6 weeks)
Secondary	MIP (maximal inspiratory pressure)	Inspiratory muscle function assessed by pressure meter	Change from baseline (0 week) to post-intervention (12 weeks)
Secondary	MIP (maximal inspiratory pressure)	Inspiratory muscle function assessed by pressure meter	Change from baseline (0 week) to follow up (24 weeks)
Secondary	MEP (maximal exspiratory pressure)	Inspiratory muscle function assessed by pressure meter	Change from baseline (0 week) to mid-intervention (6 weeks)
Secondary	MEP (maximal exspiratory pressure)	Inspiratory muscle function assessed by pressure meter	Change from baseline (0 week) to post-intervention (12 weeks)
Secondary	MEP (maximal exspiratory pressure)	Inspiratory muscle function assessed by pressure meter	Change from baseline (0 week) to follow up (24 weeks)