Clinical trial NCT05245110: Effectiveness of Tele-exercise Training on Cardiorespiratory Fitness in Patients With Cardiometabolic Multimorbidity
Official title: Tri-Service General Hospital, National Defense Medical Center
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Diseases
Type 2 Diabetes
Metabolic Syndrome
Coronary Artery Disease
Heart Failure
Keywords: exercise
physical activity
cardiorespiratory fitness
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2022-02-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel-group randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes from baseline physical activity amount at 12 weeks
timeFrame: 12 weeks
measure: Changes from baseline VO2 peak (ml/kg/min) at 12 weeks
timeFrame: 12 weeks
measure: Changes from baseline workload (Watts)at 12 weeks
timeFrame: 12 weeks
measure: Changes from baseline anaerobic threshold at 12 weeks
timeFrame: 12 weeks
measure: Changes from baseline O2 pulse (ml/beat) at 12 weeks
timeFrame: 12 weeks
measure: Changes from baseline One-min heart rate recovery (beat) at 12 weeks
timeFrame: 12 weeks
measure: Changes from baseline Two-min heart rate recovery (beat) at 12 weeks
timeFrame: 12 weeks
measure: Changes from baseline resting heart rate (bpm) at 12 weeks
timeFrame: 12 weeks
measure: Changes from baseline Resting Systolic Blood Pressure (mmHg) at 12 weeks
timeFrame: 12 weeks
measure: Changes from baseline Resting Diastolic Blood Pressure (mmHg) at 12 weeks
timeFrame: 12 weeks
measure: Changes from baseline forced vital capacity (L/min) at 12 weeks
timeFrame: 12 weeks
measure: Changes form baseline forced expiratory volume in one second (L/min) at 12 weeks
timeFrame: 12 weeks
measure: Changes from baseline FEV1/FVC (%) at 12 weeks
timeFrame: 12 weeks
measure: Changes from baseline Ejection fraction (%) at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Changes from baseline BNP at 12 weeks
timeFrame: 12 weeks
measure: Changes from baseline Health-related quality of life at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chia-Huei Lin
state: Hawaii
Study officials:
affiliation: Tri-Service General Hospital, National Defense Medical Center
name: Chia-Huei Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: