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Clinical Trials/NCT04888390
NCT04888390
Recruiting
N/A

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

National Cheng Kung University1 site in 1 country80 target enrollmentApril 20, 2021
ConditionsHeart Failure

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
National Cheng Kung University
Enrollment
80
Locations
1
Primary Endpoint
Oxygen consumption (VO2)
Status
Recruiting
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2021
End Date
December 31, 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kun-Ling Tsai

Associate Professor

National Cheng Kung University

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

Outcomes

Primary Outcomes

Oxygen consumption (VO2)

Time Frame: Change from baseline (0 week) to follow up (24 weeks)

Oxygen consumption examined by cardiopulmonary exercise test

NT-proBNP

Time Frame: Change from baseline (0 week) to follow up (24 weeks)

N-terminal pro-brain natriuretic peptide

Secondary Outcomes

  • Quality of life score (Minnesota Living With Heart Failure Questionnaire)(Change from baseline (0 week) to follow up (24 weeks))
  • MEP (maximal exspiratory pressure)(Change from baseline (0 week) to follow up (24 weeks))
  • FEV1/FVC(Change from baseline (0 week) to follow up (24 weeks))
  • MIP (maximal inspiratory pressure)(Change from baseline (0 week) to follow up (24 weeks))

Study Sites (1)

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