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Exercise Intervention on Cardiorespiratory Function in HF With DM.

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Muti-model exercise intervention
Disease and exercise suggestion
Sponsored by
National Cheng Kung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Heart failure, Diabetes mellitus, Exercise intervention, Cardiac rehabilitation

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cheng Kung UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Usual care group

Arm Description

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

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

Outcomes

Primary Outcome Measures

NT-proBNP
N-terminal pro-brain natriuretic peptide
NT-proBNP
N-terminal pro-brain natriuretic peptide
NT-proBNP
N-terminal pro-brain natriuretic peptide
Oxygen consumption (VO2)
Oxygen consumption examined by cardiopulmonary exercise test
Oxygen consumption (VO2)
Oxygen consumption examined by cardiopulmonary exercise test
Oxygen consumption (VO2)
Oxygen consumption examined by cardiopulmonary exercise test

Secondary Outcome Measures

Quality of life score (Minnesota Living With Heart Failure Questionnaire)
Heart Failure Questionnaire
Quality of life score (Minnesota Living With Heart Failure Questionnaire)
Heart Failure Questionnaire
Quality of life score (Minnesota Living With Heart Failure Questionnaire)
Heart Failure Questionnaire
FEV1/FVC
Pulmonary function test
FEV1/FVC
Pulmonary function test
FEV1/FVC
Pulmonary function test
MIP (maximal inspiratory pressure)
Inspiratory muscle function assessed by pressure meter
MIP (maximal inspiratory pressure)
Inspiratory muscle function assessed by pressure meter
MIP (maximal inspiratory pressure)
Inspiratory muscle function assessed by pressure meter
MEP (maximal exspiratory pressure)
Inspiratory muscle function assessed by pressure meter
MEP (maximal exspiratory pressure)
Inspiratory muscle function assessed by pressure meter
MEP (maximal exspiratory pressure)
Inspiratory muscle function assessed by pressure meter

Full Information

First Posted
May 5, 2021
Last Updated
May 11, 2021
Sponsor
National Cheng Kung University
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1. Study Identification

Unique Protocol Identification Number
NCT04888390
Brief Title
Exercise Intervention on Cardiorespiratory Function in HF With DM.
Official Title
The Effect of Exercise Intervention on Cardiorespiratory Function and Exercise Capacity in Heart Failure Patients With Diabetes Mellitus.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Diabetes mellitus, Exercise intervention, Cardiac rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study population will be randomized and separated in two groups, Intervention and Usual care group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group will receive multi-model exercise intervention 2-3 times per week for 3 months.
Arm Title
Usual care group
Arm Type
Active Comparator
Arm Description
The Usual care group will receive heart failure disease and exercise-related education.
Intervention Type
Behavioral
Intervention Name(s)
Muti-model exercise intervention
Intervention Description
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
Intervention Name(s)
Disease and exercise suggestion
Intervention Description
The participants will be provided by educational program about heart failure self-care and home-based exercise approach.
Primary Outcome Measure Information:
Title
NT-proBNP
Description
N-terminal pro-brain natriuretic peptide
Time Frame
Change from baseline (0 week) to mid-intervention (6 weeks)
Title
NT-proBNP
Description
N-terminal pro-brain natriuretic peptide
Time Frame
Change from baseline (0 week) to post-intervention (12 weeks)
Title
NT-proBNP
Description
N-terminal pro-brain natriuretic peptide
Time Frame
Change from baseline (0 week) to follow up (24 weeks)
Title
Oxygen consumption (VO2)
Description
Oxygen consumption examined by cardiopulmonary exercise test
Time Frame
Change from baseline (0 week) to mid-intervention (6 weeks)
Title
Oxygen consumption (VO2)
Description
Oxygen consumption examined by cardiopulmonary exercise test
Time Frame
Change from baseline (0 week) to post-intervention (12 weeks)
Title
Oxygen consumption (VO2)
Description
Oxygen consumption examined by cardiopulmonary exercise test
Time Frame
Change from baseline (0 week) to follow up (24 weeks)
Secondary Outcome Measure Information:
Title
Quality of life score (Minnesota Living With Heart Failure Questionnaire)
Description
Heart Failure Questionnaire
Time Frame
Change from baseline (0 week) to mid-intervention (6 weeks)
Title
Quality of life score (Minnesota Living With Heart Failure Questionnaire)
Description
Heart Failure Questionnaire
Time Frame
Change from baseline (0 week) to post-intervention (12 weeks)
Title
Quality of life score (Minnesota Living With Heart Failure Questionnaire)
Description
Heart Failure Questionnaire
Time Frame
Change from baseline (0 week) to follow up (24 weeks)
Title
FEV1/FVC
Description
Pulmonary function test
Time Frame
Change from baseline (0 week) to mid-intervention (6 weeks)
Title
FEV1/FVC
Description
Pulmonary function test
Time Frame
Change from baseline (0 week) to post-intervention (12 weeks)
Title
FEV1/FVC
Description
Pulmonary function test
Time Frame
Change from baseline (0 week) to follow up (24 weeks)
Title
MIP (maximal inspiratory pressure)
Description
Inspiratory muscle function assessed by pressure meter
Time Frame
Change from baseline (0 week) to mid-intervention (6 weeks)
Title
MIP (maximal inspiratory pressure)
Description
Inspiratory muscle function assessed by pressure meter
Time Frame
Change from baseline (0 week) to post-intervention (12 weeks)
Title
MIP (maximal inspiratory pressure)
Description
Inspiratory muscle function assessed by pressure meter
Time Frame
Change from baseline (0 week) to follow up (24 weeks)
Title
MEP (maximal exspiratory pressure)
Description
Inspiratory muscle function assessed by pressure meter
Time Frame
Change from baseline (0 week) to mid-intervention (6 weeks)
Title
MEP (maximal exspiratory pressure)
Description
Inspiratory muscle function assessed by pressure meter
Time Frame
Change from baseline (0 week) to post-intervention (12 weeks)
Title
MEP (maximal exspiratory pressure)
Description
Inspiratory muscle function assessed by pressure meter
Time Frame
Change from baseline (0 week) to follow up (24 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kun-Ling Tsai, Ph.D.
Phone
886-6-2353535
Ext
6219
Email
kunlingtsai@mail.ncku.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Hsin-Lun Yang, M.S.
Phone
886-6-2353535
Ext
5078
Email
t66064043@pt.ncku.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun-Ling Tsai, Ph.D.
Organizational Affiliation
Department of Physical Therapy, National Cheng Kung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University
City
Tainan
ZIP/Postal Code
701
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
kun-Ling Tsai, Ph.D.
Phone
886-6-2353535
Ext
6219
Email
kunlingtsai@mail.ncku.edu.tw
First Name & Middle Initial & Last Name & Degree
Hsin-Lun Yang, M.S.
Phone
886-6-2353535
Ext
5078
Email
t66064043@pt.ncku.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD sharing plan will be decided after summarized data being published.

Learn more about this trial

Exercise Intervention on Cardiorespiratory Function in HF With DM.

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