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

Not Applicable
Conditions
Metabolic Syndrome
Heart Diseases
Type 2 Diabetes
Heart Failure
Coronary Artery Disease
Interventions
Behavioral: tele-exercise training
Registration Number
NCT05245110
Lead Sponsor
Tri-Service General Hospital
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
200
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
experimental grouptele-exercise trainingreceived a tele-exercise training program
Primary Outcome Measures
NameTimeMethod
Changes from baseline VO2 peak (ml/kg/min) at 12 weeks12 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 resting heart rate (bpm) at 12 weeks12 weeks

Resting heart rate (bpm) obtained using electronic BP monitor devices (Terumo, ESP2000)

Changes from baseline One-min heart rate recovery (beat) at 12 weeks12 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 form baseline forced expiratory volume in one second (L/min) at 12 weeks12 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 BNP at 12 weeks12 weeks

BNP through blood analysis

Changes from baseline workload (Watts)at 12 weeks12 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 O2 pulse (ml/beat) at 12 weeks12 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 Two-min heart rate recovery (beat) at 12 weeks12 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 physical activity amount at 12 weeks12 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 anaerobic threshold at 12 weeks12 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 Resting Systolic Blood Pressure (mmHg) at 12 weeks12 weeks

Resting Systolic Blood Pressure (mmHg) obtained using electronic BP monitor devices (Terumo, ESP2000)

Changes from baseline Resting Diastolic Blood Pressure (mmHg) at 12 weeks12 weeks

Resting Diastolic Blood Pressure (mmHg), obtained using electronic BP monitor devices (Terumo, ESP2000)

Changes from baseline forced vital capacity (L/min) at 12 weeks12 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 from baseline FEV1/FVC (%) at 12 weeks12 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 weeksBaseline and 12 weeks

Ejection fraction (%) data were collected through chart review

Changes from baseline Health-related quality of life at 12 weeks12 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
NameTimeMethod

Trial Locations

Locations (1)

Chia-Huei Lin

🇨🇳

Taipei, Hawaii, Taiwan

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