Exercise Intervention on Cardiorespiratory Function in HF With DM.

NCT04888390 | Unknown

• 1 other identifier: B-BR-110-016
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Keywords

Heart failure; Diabetes mellitus; Exercise intervention; Cardiac rehabilitation

Outcome Measures

Primary Outcomes (6)

• NT-proBNP

  N-terminal pro-brain natriuretic peptide

  Change from baseline (0 week) to mid-intervention (6 weeks)

• NT-proBNP

  N-terminal pro-brain natriuretic peptide

  Change from baseline (0 week) to post-intervention (12 weeks)

• NT-proBNP

  N-terminal pro-brain natriuretic peptide

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

• Oxygen consumption (VO2)

  Oxygen consumption examined by cardiopulmonary exercise test

  Change from baseline (0 week) to mid-intervention (6 weeks)

• Oxygen consumption (VO2)

  Oxygen consumption examined by cardiopulmonary exercise test

  Change from baseline (0 week) to post-intervention (12 weeks)

• Oxygen consumption (VO2)

  Oxygen consumption examined by cardiopulmonary exercise test

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

Secondary Outcomes (12)

• Quality of life score (Minnesota Living With Heart Failure Questionnaire)

  Change from baseline (0 week) to mid-intervention (6 weeks)

• Quality of life score (Minnesota Living With Heart Failure Questionnaire)

  Change from baseline (0 week) to post-intervention (12 weeks)

• Quality of life score (Minnesota Living With Heart Failure Questionnaire)

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

• FEV1/FVC

  Change from baseline (0 week) to mid-intervention (6 weeks)

• FEV1/FVC

  Change from baseline (0 week) to post-intervention (12 weeks)

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Muti-model exercise intervention

Usual care group

ACTIVE COMPARATOR

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

Behavioral: Disease and exercise suggestion

Interventions

Muti-model exercise intervention 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.

Intervention group

Disease and exercise suggestion BEHAVIORAL

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

Usual care group

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Heart Failure (NYHA I-III) with diabetes mellitus
• Aged 30-85
• Mini-mental state examination score \> 25

You may not qualify if:

• eGFR \< 30mL/min/1.73m2
• Exercise intervention contraindication of heart failure
• Pregnancy
• Uncontrolled disease

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

National Cheng Kung University

Tainan, 701, Taiwan

RECRUITING

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kun-Ling Tsai, Ph.D.

  Department of Physical Therapy, National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun-Ling Tsai, Ph.D.

CONTACT

886-6-2353535; kunlingtsai@mail.ncku.edu.tw

Hsin-Lun Yang, M.S.

CONTACT

886-6-2353535; t66064043@pt.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study population will be randomized and separated in two groups, Intervention and Usual care group.

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 17, 2021
• Study Start: April 20, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)