Exercise Intervention on Cardiorespiratory Function in HF With DM.

NCT ID: NCT04888390

Last Updated: 2021-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-20

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study population will be randomized and separated in two groups, Intervention and Usual care group.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

The intervention group will receive multi-model exercise intervention 2-3 times per week for 3 months.

Group Type EXPERIMENTAL

Muti-model exercise intervention

Intervention Type BEHAVIORAL

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.

Usual care group

The Usual care group will receive heart failure disease and exercise-related education.

Group Type ACTIVE_COMPARATOR

Disease and exercise suggestion

Intervention Type BEHAVIORAL

The participants will be provided by educational program about heart failure self-care and home-based exercise approach.

Interventions

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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.

Intervention Type BEHAVIORAL

Disease and exercise suggestion

The participants will be provided by educational program about heart failure self-care and home-based exercise approach.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng Kung University

OTHER

Sponsor Role lead

Responsible Party

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Kun-Ling Tsai

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kun-Ling Tsai, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Therapy, National Cheng Kung University

Locations

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National Cheng Kung University

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Kun-Ling Tsai, Ph.D.

Role: CONTACT

886-6-2353535 ext. 6219

Hsin-Lun Yang, M.S.

Role: CONTACT

886-6-2353535 ext. 5078

Facility Contacts

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kun-Ling Tsai, Ph.D.

Role: primary

886-6-2353535 ext. 6219

Hsin-Lun Yang, M.S.

Role: backup

886-6-2353535 ext. 5078

Other Identifiers

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B-BR-110-016

Identifier Type: -

Identifier Source: org_study_id

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