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

February 8, 2022 updated by: CHIA-HUEI LIN, PhD, Tri-Service General Hospital

Tri-Service General Hospital, National Defense Medical Center

This trial aimed to assess whether assumed increase in physical activity after tele-exercise training can improve cardiorespiratory fitness of patients with cardiometabolic multimorbidity.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • 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 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

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
received a tele-exercise training program
Behavioral: tele-exercise training
a 12-week tele-exercise training program
No Intervention: control group
usual care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline physical activity amount at 12 weeks
Time Frame: 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
12 weeks
Changes from baseline VO2 peak (ml/kg/min) at 12 weeks
Time Frame: 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.
12 weeks
Changes from baseline workload (Watts)at 12 weeks
Time Frame: 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.
12 weeks
Changes from baseline anaerobic threshold at 12 weeks
Time Frame: 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.
12 weeks
Changes from baseline O2 pulse (ml/beat) at 12 weeks
Time Frame: 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.
12 weeks
Changes from baseline One-min heart rate recovery (beat) at 12 weeks
Time Frame: 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.
12 weeks
Changes from baseline Two-min heart rate recovery (beat) at 12 weeks
Time Frame: 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.
12 weeks
Changes from baseline resting heart rate (bpm) at 12 weeks
Time Frame: 12 weeks
Resting heart rate (bpm) obtained using electronic BP monitor devices (Terumo, ESP2000)
12 weeks
Changes from baseline Resting Systolic Blood Pressure (mmHg) at 12 weeks
Time Frame: 12 weeks
Resting Systolic Blood Pressure (mmHg) obtained using electronic BP monitor devices (Terumo, ESP2000)
12 weeks
Changes from baseline Resting Diastolic Blood Pressure (mmHg) at 12 weeks
Time Frame: 12 weeks
Resting Diastolic Blood Pressure (mmHg), obtained using electronic BP monitor devices (Terumo, ESP2000)
12 weeks
Changes from baseline forced vital capacity (L/min) at 12 weeks
Time Frame: 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.
12 weeks
Changes form baseline forced expiratory volume in one second (L/min) at 12 weeks
Time Frame: 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.
12 weeks
Changes from baseline FEV1/FVC (%) at 12 weeks
Time Frame: 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.
12 weeks
Changes from baseline Ejection fraction (%) at 12 weeks
Time Frame: Baseline and 12 weeks
Ejection fraction (%) data were collected through chart review
Baseline and 12 weeks
Changes from baseline BNP at 12 weeks
Time Frame: 12 weeks
BNP through blood analysis
12 weeks
Changes from baseline Health-related quality of life at 12 weeks
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Collaborators

Ministry of Science and Technology, Taiwan

Investigators

  • Principal Investigator: Chia-Huei Lin, PhD, Tri-Service General Hospital, National Defense Medical Center

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)

April 1, 2018

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

January 29, 2022

First Submitted That Met QC Criteria

February 8, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSGHIRB: 1-106-05-107

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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