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| Name | Class |
|---|---|
| Ministry of Science and Technology, Taiwan | OTHER_GOV |
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This trial aimed to assess whether assumed increase in physical activity after tele-exercise training can improve cardiorespiratory fitness of patients with cardiometabolic multimorbidity.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | received a tele-exercise training program |
|
| control group | No Intervention | usual care only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tele-exercise training | Behavioral | a 12-week tele-exercise training program |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chia-Huei Lin, PhD | Contact | +886-920328195 | andyy520@mail.ndmctsgh.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Chia-Huei Lin, PhD | Tri-Service General Hospital, National Defense Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chia-Huei Lin | Recruiting | Taipei | Hawaii | 11105 | Taiwan |
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A parallel-group randomized controlled trial
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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.
| 12 weeks |
| 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 |
| 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 |
| Changes from baseline resting heart rate (bpm) at 12 weeks | Resting heart rate (bpm) obtained using electronic BP monitor devices (Terumo, ESP2000) | 12 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Changes from baseline Ejection fraction (%) at 12 weeks | Ejection fraction (%) data were collected through chart review | Baseline and 12 weeks |
| Changes from baseline BNP at 12 weeks | BNP through blood analysis | 12 weeks |
| 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 |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D003924 | Diabetes Mellitus, Type 2 |
| D024821 | Metabolic Syndrome |
| D003324 | Coronary Artery Disease |
| D006333 | Heart Failure |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D001519 | Behavior |
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