Coronary Artery Disease, Heart Diseases, Heart Failure, Metabolic Syndrome, Type 2 Diabetes
Conditions
Keywords
exercise, physical activity, cardiorespiratory fitness
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.
Interventions
BEHAVIORALtele-exercise training
a 12-week tele-exercise training program
Sponsors
Ministry of Science and Technology, Taiwan
Tri-Service General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.
Intervention model description
A parallel-group randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan
Contacts
Primary ContactChia-Huei Lin, PhD
Outcome results
None listed