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

Sponsor

Tri-Service General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05245110

Collaborator

Ministry of Science and Technology, Taiwan (Other)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Diseases Type 2 Diabetes Metabolic Syndrome Coronary Artery Disease Heart Failure	Behavioral: tele-exercise training	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A parallel-group randomized controlled trialA parallel-group randomized controlled trial

Masking:

Single (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.

Primary Purpose:

Treatment

Official Title:

Tri-Service General Hospital, National Defense Medical Center

Actual Study Start Date :

Apr 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Changes from baseline physical activity amount at 12 weeks [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [Baseline and 12 weeks]
Ejection fraction (%) data were collected through chart review
Changes from baseline BNP at 12 weeks [12 weeks]
BNP through blood analysis
Changes from baseline Health-related quality of life at 12 weeks [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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