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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tri-Service General Hospital, National Defense Medical Center

Conditions
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Heart Diseases, Type 2 Diabetes, Metabolic Syndrome, Coronary Artery Disease, Heart Failure

Intervention / Treatment
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* Behavioral: tele-exercise training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A parallel-group randomized controlled trial
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 
| 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. | 12 weeks | 
| 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. | 12 weeks | 
| 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. | 12 weeks | 
| 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. | 12 weeks | 
| 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. | 12 weeks | 
| 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. | 12 weeks | 
| Changes from baseline resting heart rate (bpm) at 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 | 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 | 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 | 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 | 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 | 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 | Ejection fraction (%) data were collected through chart review | Baseline and 12 weeks | 
| Changes from baseline BNP at 12 weeks | BNP through blood analysis | 12 weeks | 
| 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, physical activity, cardiorespiratory fitness