search
Back to results

Effectiveness of Tele-exercise Training on Cardiorespiratory Fitness in Patients With Cardiometabolic Multimorbidity

Primary Purpose

Heart Diseases, Type 2 Diabetes, Metabolic Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
tele-exercise training
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Diseases focused on measuring exercise, physical activity, cardiorespiratory fitness

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnoses of cardiometabolic multimorbidity, defined as the presence of two or more cardiometabolic conditions (i.e., hypertension, type 2 diabetes, hyperlipidaemia, heart disease, metabolic syndrome, or gout)
  • Aged 18-80 years
  • Able to speak and understand Mandarin
  • Able to walk without assistance
  • Had mobile phones and could easily access the Internet

Exclusion Criteria:

  • Not match the diagnosis of cardiometabolic multimorbidity; and a history of arrhythmia, cancer, end-stage renal disease with dialysis, being diagnosed with mental illness, recent stroke within 6 months
  • Not able to speak and understand Mandarin
  • Not able to walk independently or inability to participate due to comorbid neurological, musculoskeletal conditions that produce moderate-to-severe physical disability
  • Did not have mobile phones or could not access the internet at home and whenever necessary

Sites / Locations

  • Chia-Huei LinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

control group

Arm Description

received a tele-exercise training program

usual care only

Outcomes

Primary Outcome Measures

Changes from baseline physical activity amount at 12 weeks
weekly amount of physical activity using the well-validated and reliable Taiwan version of 7-item International Physical Activity Questionnaire to measure. The scores of International Physical Activity Questionnaire expressed as "MET-minutes/week". Higher score indicates higher physical activity amounts
Changes from baseline VO2 peak (ml/kg/min) at 12 weeks
VO2 peak (ml/kg/min), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Changes from baseline workload (Watts)at 12 weeks
Workload (Watts), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Changes from baseline anaerobic threshold at 12 weeks
anaerobic threshold, detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Changes from baseline O2 pulse (ml/beat) at 12 weeks
O2 pulse (ml/beat), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Changes from baseline One-min heart rate recovery (beat) at 12 weeks
One-min heart rate recovery (beat), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Changes from baseline Two-min heart rate recovery (beat) at 12 weeks
Two-min heart rate recovery (beat), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Changes from baseline resting heart rate (bpm) at 12 weeks
Resting heart rate (bpm) obtained using electronic BP monitor devices (Terumo, ESP2000)
Changes from baseline Resting Systolic Blood Pressure (mmHg) at 12 weeks
Resting Systolic Blood Pressure (mmHg) obtained using electronic BP monitor devices (Terumo, ESP2000)
Changes from baseline Resting Diastolic Blood Pressure (mmHg) at 12 weeks
Resting Diastolic Blood Pressure (mmHg), obtained using electronic BP monitor devices (Terumo, ESP2000)
Changes from baseline forced vital capacity (L/min) at 12 weeks
forced vital capacity (L/min), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Changes form baseline forced expiratory volume in one second (L/min) at 12 weeks
forced expiratory volume in one second (L/min), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Changes from baseline FEV1/FVC (%) at 12 weeks
FEV1/FVC (%) detected during graded exercise testing, , performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Changes from baseline Ejection fraction (%) at 12 weeks
Ejection fraction (%) data were collected through chart review
Changes from baseline BNP at 12 weeks
BNP through blood analysis
Changes from baseline Health-related quality of life at 12 weeks
Health-related quality of life useing the reliable and valid Taiwan version of Medical Outcomes Study Short-Form 36 to measure. Scores ranged from 0 to 100, with higher scores indicating better health-related quality of life.

Secondary Outcome Measures

Full Information

First Posted
January 29, 2022
Last Updated
February 8, 2022
Sponsor
Tri-Service General Hospital
Collaborators
Ministry of Science and Technology, Taiwan
search

1. Study Identification

Unique Protocol Identification Number
NCT05245110
Brief Title
Effectiveness of Tele-exercise Training on Cardiorespiratory Fitness in Patients With Cardiometabolic Multimorbidity
Official Title
Tri-Service General Hospital, National Defense Medical Center
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital
Collaborators
Ministry of Science and Technology, Taiwan

4. Oversight

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

5. Study Description

Brief Summary
This trial aimed to assess whether assumed increase in physical activity after tele-exercise training can improve cardiorespiratory fitness of patients with cardiometabolic multimorbidity.
Detailed Description
A parallel-group randomized controlled trial was conducted. Eligible patients with cardiometabolic multimorbidity were randomized 1:1 to either experimental group (EG, received a tele-exercise training program) or control group (CG, usual care only). The intervention encompassed tele-exercise training program (30 min/session, 3 sessions/week) and weekly remote monitoring for maintenance of exercise. Physical activity and cardiorespiratory fitness were assessed at baseline and 12 weeks. Generalized estimating equations were used to examine the intervention effects via the interaction of time and group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases, Type 2 Diabetes, Metabolic Syndrome, Coronary Artery Disease, Heart Failure
Keywords
exercise, physical activity, cardiorespiratory fitness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A parallel-group randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Eligible participants were invited to data collection including sociodemographic characteristics and outcome measures in a local medical centre at baseline and 12 weeks by a separate research nurse, blinded to the group assignments.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
received a tele-exercise training program
Arm Title
control group
Arm Type
No Intervention
Arm Description
usual care only
Intervention Type
Behavioral
Intervention Name(s)
tele-exercise training
Intervention Description
a 12-week tele-exercise training program
Primary Outcome Measure Information:
Title
Changes from baseline physical activity amount at 12 weeks
Description
weekly amount of physical activity using the well-validated and reliable Taiwan version of 7-item International Physical Activity Questionnaire to measure. The scores of International Physical Activity Questionnaire expressed as "MET-minutes/week". Higher score indicates higher physical activity amounts
Time Frame
12 weeks
Title
Changes from baseline VO2 peak (ml/kg/min) at 12 weeks
Description
VO2 peak (ml/kg/min), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Time Frame
12 weeks
Title
Changes from baseline workload (Watts)at 12 weeks
Description
Workload (Watts), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Time Frame
12 weeks
Title
Changes from baseline anaerobic threshold at 12 weeks
Description
anaerobic threshold, detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Time Frame
12 weeks
Title
Changes from baseline O2 pulse (ml/beat) at 12 weeks
Description
O2 pulse (ml/beat), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Time Frame
12 weeks
Title
Changes from baseline One-min heart rate recovery (beat) at 12 weeks
Description
One-min heart rate recovery (beat), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Time Frame
12 weeks
Title
Changes from baseline Two-min heart rate recovery (beat) at 12 weeks
Description
Two-min heart rate recovery (beat), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Time Frame
12 weeks
Title
Changes from baseline resting heart rate (bpm) at 12 weeks
Description
Resting heart rate (bpm) obtained using electronic BP monitor devices (Terumo, ESP2000)
Time Frame
12 weeks
Title
Changes from baseline Resting Systolic Blood Pressure (mmHg) at 12 weeks
Description
Resting Systolic Blood Pressure (mmHg) obtained using electronic BP monitor devices (Terumo, ESP2000)
Time Frame
12 weeks
Title
Changes from baseline Resting Diastolic Blood Pressure (mmHg) at 12 weeks
Description
Resting Diastolic Blood Pressure (mmHg), obtained using electronic BP monitor devices (Terumo, ESP2000)
Time Frame
12 weeks
Title
Changes from baseline forced vital capacity (L/min) at 12 weeks
Description
forced vital capacity (L/min), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Time Frame
12 weeks
Title
Changes form baseline forced expiratory volume in one second (L/min) at 12 weeks
Description
forced expiratory volume in one second (L/min), detected during graded exercise testing, performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Time Frame
12 weeks
Title
Changes from baseline FEV1/FVC (%) at 12 weeks
Description
FEV1/FVC (%) detected during graded exercise testing, , performed using a motorized ergometer (Corival, Lode, Netherlands) with a standardized ramp protocol by increasing the resistance (10 watt per minute) at a consistent speed of 60 revolutions per minute.
Time Frame
12 weeks
Title
Changes from baseline Ejection fraction (%) at 12 weeks
Description
Ejection fraction (%) data were collected through chart review
Time Frame
Baseline and 12 weeks
Title
Changes from baseline BNP at 12 weeks
Description
BNP through blood analysis
Time Frame
12 weeks
Title
Changes from baseline Health-related quality of life at 12 weeks
Description
Health-related quality of life useing the reliable and valid Taiwan version of Medical Outcomes Study Short-Form 36 to measure. Scores ranged from 0 to 100, with higher scores indicating better health-related quality of life.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnoses of cardiometabolic multimorbidity, defined as the presence of two or more cardiometabolic conditions (i.e., hypertension, type 2 diabetes, hyperlipidaemia, heart disease, metabolic syndrome, or gout) Aged 18-80 years Able to speak and understand Mandarin Able to walk without assistance Had mobile phones and could easily access the Internet Exclusion Criteria: Not match the diagnosis of cardiometabolic multimorbidity; and a history of arrhythmia, cancer, end-stage renal disease with dialysis, being diagnosed with mental illness, recent stroke within 6 months Not able to speak and understand Mandarin Not able to walk independently or inability to participate due to comorbid neurological, musculoskeletal conditions that produce moderate-to-severe physical disability Did not have mobile phones or could not access the internet at home and whenever necessary
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Huei Lin, PhD
Phone
+886-920328195
Email
andyy520@mail.ndmctsgh.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Huei Lin, PhD
Organizational Affiliation
Tri-Service General Hospital, National Defense Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chia-Huei Lin
City
Taipei
State/Province
Hawaii
ZIP/Postal Code
11105
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia-Huei Lin, PhD
Phone
+8862785116
Email
andyy520@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Shang-Lin Chiang, PhD
Phone
+8862785116
Email
andyyy520@yahoo.com.tw

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Tele-exercise Training on Cardiorespiratory Fitness in Patients With Cardiometabolic Multimorbidity

We'll reach out to this number within 24 hrs