Exercise Intervention on Cardiorespiratory Function in HF With DM.

May 11, 2021 updated by: Kun-Ling Tsai, National Cheng Kung University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group
The intervention group will receive multi-model exercise intervention 2-3 times per week for 3 months.
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.
ACTIVE_COMPARATOR: Usual care group
The Usual care group will receive heart failure disease and exercise-related education.
Behavioral: Disease and exercise suggestion
The participants will be provided by educational program about heart failure self-care and home-based exercise approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NT-proBNP
Time Frame: Change from baseline (0 week) to mid-intervention (6 weeks)
N-terminal pro-brain natriuretic peptide
Change from baseline (0 week) to mid-intervention (6 weeks)
NT-proBNP
Time Frame: Change from baseline (0 week) to post-intervention (12 weeks)
N-terminal pro-brain natriuretic peptide
Change from baseline (0 week) to post-intervention (12 weeks)
NT-proBNP
Time Frame: Change from baseline (0 week) to follow up (24 weeks)
N-terminal pro-brain natriuretic peptide
Change from baseline (0 week) to follow up (24 weeks)
Oxygen consumption (VO2)
Time Frame: Change from baseline (0 week) to mid-intervention (6 weeks)
Oxygen consumption examined by cardiopulmonary exercise test
Change from baseline (0 week) to mid-intervention (6 weeks)
Oxygen consumption (VO2)
Time Frame: Change from baseline (0 week) to post-intervention (12 weeks)
Oxygen consumption examined by cardiopulmonary exercise test
Change from baseline (0 week) to post-intervention (12 weeks)
Oxygen consumption (VO2)
Time Frame: Change from baseline (0 week) to follow up (24 weeks)
Oxygen consumption examined by cardiopulmonary exercise test
Change from baseline (0 week) to follow up (24 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life score (Minnesota Living With Heart Failure Questionnaire)
Time Frame: Change from baseline (0 week) to mid-intervention (6 weeks)
Heart Failure Questionnaire
Change from baseline (0 week) to mid-intervention (6 weeks)
Quality of life score (Minnesota Living With Heart Failure Questionnaire)
Time Frame: Change from baseline (0 week) to post-intervention (12 weeks)
Heart Failure Questionnaire
Change from baseline (0 week) to post-intervention (12 weeks)
Quality of life score (Minnesota Living With Heart Failure Questionnaire)
Time Frame: Change from baseline (0 week) to follow up (24 weeks)
Heart Failure Questionnaire
Change from baseline (0 week) to follow up (24 weeks)
FEV1/FVC
Time Frame: Change from baseline (0 week) to mid-intervention (6 weeks)
Pulmonary function test
Change from baseline (0 week) to mid-intervention (6 weeks)
FEV1/FVC
Time Frame: Change from baseline (0 week) to post-intervention (12 weeks)
Pulmonary function test
Change from baseline (0 week) to post-intervention (12 weeks)
FEV1/FVC
Time Frame: Change from baseline (0 week) to follow up (24 weeks)
Pulmonary function test
Change from baseline (0 week) to follow up (24 weeks)
MIP (maximal inspiratory pressure)
Time Frame: Change from baseline (0 week) to mid-intervention (6 weeks)
Inspiratory muscle function assessed by pressure meter
Change from baseline (0 week) to mid-intervention (6 weeks)
MIP (maximal inspiratory pressure)
Time Frame: Change from baseline (0 week) to post-intervention (12 weeks)
Inspiratory muscle function assessed by pressure meter
Change from baseline (0 week) to post-intervention (12 weeks)
MIP (maximal inspiratory pressure)
Time Frame: Change from baseline (0 week) to follow up (24 weeks)
Inspiratory muscle function assessed by pressure meter
Change from baseline (0 week) to follow up (24 weeks)
MEP (maximal exspiratory pressure)
Time Frame: Change from baseline (0 week) to mid-intervention (6 weeks)
Inspiratory muscle function assessed by pressure meter
Change from baseline (0 week) to mid-intervention (6 weeks)
MEP (maximal exspiratory pressure)
Time Frame: Change from baseline (0 week) to post-intervention (12 weeks)
Inspiratory muscle function assessed by pressure meter
Change from baseline (0 week) to post-intervention (12 weeks)
MEP (maximal exspiratory pressure)
Time Frame: Change from baseline (0 week) to follow up (24 weeks)
Inspiratory muscle function assessed by pressure meter
Change from baseline (0 week) to follow up (24 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng Kung University

Investigators

  • Principal Investigator: Kun-Ling Tsai, Ph.D., Department of Physical Therapy, National Cheng Kung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 20, 2021

Primary Completion (ANTICIPATED)

December 31, 2024

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (ACTUAL)

May 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2021

Last Update Submitted That Met QC Criteria

May 11, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-BR-110-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD sharing plan will be decided after summarized data being published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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