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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cheng Kung University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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