Tri-Service General Hospital, National Defense Medical Center
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Diseases
- Sponsor
- Tri-Service General Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Changes from baseline VO2 peak (ml/kg/min) at 12 weeks
- Last Updated
- 4 years ago
Overview
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.
Investigators
CHIA-HUEI LIN, PhD
Associate Professor and Deputy Director of Nursing Department
Tri-Service General Hospital
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
Outcomes
Primary Outcomes
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.
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)
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.
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.
Changes from baseline BNP at 12 weeks
Time Frame: 12 weeks
BNP through blood analysis
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.
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.
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.
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
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.
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)
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)
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.
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.
Changes from baseline Ejection fraction (%) at 12 weeks
Time Frame: Baseline and 12 weeks
Ejection fraction (%) data were collected through chart review
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.