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

Coronary Artery Disease Clinical Trial

Official title:

Tri-Service General Hospital, National Defense Medical Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05245110
• Other study ID #: TSGHIRB: 1-106-05-107
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2022
• Source: Tri-Service General Hospital
• Contact: Chia-Huei Lin, PhD
• Phone: +886-920328195
• Email: andyy520[@]mail.ndmctsgh.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Heart Failure
• Metabolic Syndrome
• Type 2 Diabetes

Intervention

Behavioral:
• tele-exercise training
a 12-week tele-exercise training program

Locations

Country	Name	City	State
Taiwan	Chia-Huei Lin	Taipei	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
Tri-Service General Hospital	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Changes from baseline resting heart rate (bpm) at 12 weeks	Resting heart rate (bpm) obtained using electronic BP monitor devices (Terumo, ESP2000)	12 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Changes from baseline Ejection fraction (%) at 12 weeks	Ejection fraction (%) data were collected through chart review	Baseline and 12 weeks
Primary	Changes from baseline BNP at 12 weeks	BNP through blood analysis	12 weeks
Primary	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