Trial Outcomes & Findings for Telerehabilitation in People With Long COVID (NCT NCT05205460)
NCT ID: NCT05205460
Last Updated: 2025-03-11
Results Overview
The peak oxygen uptake (VO2peak) is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in VO2 peak was calculated as the value at 12 weeks minus the value at baseline. A higher VO2 peak indicates better exercise capacity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
182 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2025-03-11
Participant Flow
Participant milestones
| Measure |
Home-based Telerehabilitation
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes). Then, the participants will start a home-based telehealth exercise training program (30minutes/session, 3 sessions/week for 12weeks, with a total of 36 sessions) combined with heart rate sensing clothes. Exercise type: brisk walking, jogging, or stationary ergometer exercise.
Home-based telehealth exercise training program: A home-based exercise mobile app will be offered combined with the heart rate sensing clothes to each participant in the group of home-based telehealth exercise training program. The mobile app provides auto-feedback of heart rate at each exercise training session through the heart rate sensing clothes and alarm function identifying individuals' appropriate exercise intensity (target heart rate) during their exercise based on their exercise prescription calculated and set up inside the app. After completing each exercise training session, the record of training time and heart rate response is simultaneously uploaded to the cloud system of the medical center through the heart rate sensing clothes. The experienced and well-trained nurse checked the cloud system data to monitor participants' adherence to exercise training. In addition, online communication is enabled using LINE software, which provided a platform for patients and researchers to interact with each other through messaging.
|
Education and Self-exercise
After graded exercise testing, the participants will receive only a single, individual, face-to-face physical activity promotion counseling session (15-20minutes).
Education and self-exercise: The participants will receive a exercise prescription suggestion. Then, they will maintain their usual lifestyles without exercise reminders.
|
|---|---|---|
|
Overall Study
STARTED
|
91
|
91
|
|
Overall Study
COMPLETED
|
56
|
66
|
|
Overall Study
NOT COMPLETED
|
35
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telerehabilitation in People With Long COVID
Baseline characteristics by cohort
| Measure |
Home-based Telerehabilitation
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes). Then, the participants will start a home-based telehealth exercise training program (30minutes/session, 3 sessions/week for 12weeks, with a total of 36 sessions) combined with heart rate sensing clothes. Exercise type: brisk walking, jogging, or stationary ergometer exercise.
Home-based telehealth exercise training program: A home-based exercise mobile app will be offered combined with the heart rate sensing clothes to each participant in the group of home-based telehealth exercise training program. The mobile app provides auto-feedback of heart rate at each exercise training session through the heart rate sensing clothes and alarm function identifying individuals' appropriate exercise intensity (target heart rate) during their exercise based on their exercise prescription calculated and set up inside the app. After completing each exercise training session, the record of training time and heart rate response is simultaneously uploaded to the cloud system of the medical center through the heart rate sensing clothes. The experienced and well-trained nurse checked the cloud system data to monitor participants' adherence to exercise training. In addition, online communication is enabled using LINE software, which provided a platform for patients and researchers to interact with each other through messaging.
|
Education and Self-exercise
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes).
Then, the patients will maintain their usual lifestyles for 12 weeks without exercise reminders.
Education and self-exercise: The participants will receive a exercise prescription suggestion. Then, they will maintain their usual lifestyles without exercise reminders.
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age(years)
|
38.9 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
40.8 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
39.9 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
91 participants
n=5 Participants
|
91 participants
n=7 Participants
|
182 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
91 participants
n=5 Participants
|
91 participants
n=7 Participants
|
182 participants
n=5 Participants
|
|
Duration of post-COVID-19 (weeks)
|
13.1 weeks
STANDARD_DEVIATION 7.5 • n=5 Participants
|
11.5 weeks
STANDARD_DEVIATION 5.7 • n=7 Participants
|
12.1 weeks
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Body mass index (kg/m2)
|
23.4 kg/m2
STANDARD_DEVIATION 3.9 • n=5 Participants
|
24.3 kg/m2
STANDARD_DEVIATION 5.2 • n=7 Participants
|
23.9 kg/m2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksThe peak oxygen uptake (VO2peak) is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in VO2 peak was calculated as the value at 12 weeks minus the value at baseline. A higher VO2 peak indicates better exercise capacity.
Outcome measures
| Measure |
Home-based Telerehabilitation
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes). Then, the participants will start a home-based telehealth exercise training program (30minutes/session, 3 sessions/week for 12weeks, with a total of 36 sessions) combined with heart rate sensing clothes. Exercise type: brisk walking, jogging, or stationary ergometer exercise.
Home-based telehealth exercise training program: A home-based exercise mobile app will be offered combined with the heart rate sensing clothes to each participant in the group of home-based telehealth exercise training program. The mobile app provides auto-feedback of heart rate at each exercise training session through the heart rate sensing clothes and alarm function identifying individuals' appropriate exercise intensity (target heart rate) during their exercise based on their exercise prescription calculated and set up inside the app. After completing each exercise training session, the record of training time and heart rate response is simultaneously uploaded to the cloud system of the medical center through the heart rate sensing clothes. The experienced and well-trained nurse checked the cloud system data to monitor participants' adherence to exercise training. In addition, online communication is enabled using LINE software, which provided a platform for patients and researchers to interact with each other through messaging.
|
Education and Self-exercise
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes).
Then, the patients will maintain their usual lifestyles for 12 weeks without exercise reminders.
Education and self-exercise: The participants will receive a exercise prescription suggestion. Then, they will maintain their usual lifestyles without exercise reminders.
|
|---|---|---|
|
Change in Exercise Capacity: Peak Oxygen Uptake (VO2peak) From Baseline to 12 Weeks
|
2.4 ml/kg/min
Standard Deviation 4.4
|
1.7 ml/kg/min
Standard Deviation 4.1
|
PRIMARY outcome
Timeframe: baseline, 12 weeksThe workload (Watt) is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in workload was calculated as the value at 12 weeks minus the value at baseline. A higher workload indicates better exercise capacity.
Outcome measures
| Measure |
Home-based Telerehabilitation
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes). Then, the participants will start a home-based telehealth exercise training program (30minutes/session, 3 sessions/week for 12weeks, with a total of 36 sessions) combined with heart rate sensing clothes. Exercise type: brisk walking, jogging, or stationary ergometer exercise.
Home-based telehealth exercise training program: A home-based exercise mobile app will be offered combined with the heart rate sensing clothes to each participant in the group of home-based telehealth exercise training program. The mobile app provides auto-feedback of heart rate at each exercise training session through the heart rate sensing clothes and alarm function identifying individuals' appropriate exercise intensity (target heart rate) during their exercise based on their exercise prescription calculated and set up inside the app. After completing each exercise training session, the record of training time and heart rate response is simultaneously uploaded to the cloud system of the medical center through the heart rate sensing clothes. The experienced and well-trained nurse checked the cloud system data to monitor participants' adherence to exercise training. In addition, online communication is enabled using LINE software, which provided a platform for patients and researchers to interact with each other through messaging.
|
Education and Self-exercise
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes).
Then, the patients will maintain their usual lifestyles for 12 weeks without exercise reminders.
Education and self-exercise: The participants will receive a exercise prescription suggestion. Then, they will maintain their usual lifestyles without exercise reminders.
|
|---|---|---|
|
Change in Exercise Capacity: Workload (Watt) From Baseline to 12 Weeks
|
7.0 watts
Standard Deviation 12.1
|
7.3 watts
Standard Deviation 13.8
|
PRIMARY outcome
Timeframe: baseline, 12 weeksThe anaerobic threshold (AT) is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in AT was calculated as the value at 12 weeks minus the value at baseline. A higher AT indicates better exercise capacity and endurance.
Outcome measures
| Measure |
Home-based Telerehabilitation
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes). Then, the participants will start a home-based telehealth exercise training program (30minutes/session, 3 sessions/week for 12weeks, with a total of 36 sessions) combined with heart rate sensing clothes. Exercise type: brisk walking, jogging, or stationary ergometer exercise.
Home-based telehealth exercise training program: A home-based exercise mobile app will be offered combined with the heart rate sensing clothes to each participant in the group of home-based telehealth exercise training program. The mobile app provides auto-feedback of heart rate at each exercise training session through the heart rate sensing clothes and alarm function identifying individuals' appropriate exercise intensity (target heart rate) during their exercise based on their exercise prescription calculated and set up inside the app. After completing each exercise training session, the record of training time and heart rate response is simultaneously uploaded to the cloud system of the medical center through the heart rate sensing clothes. The experienced and well-trained nurse checked the cloud system data to monitor participants' adherence to exercise training. In addition, online communication is enabled using LINE software, which provided a platform for patients and researchers to interact with each other through messaging.
|
Education and Self-exercise
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes).
Then, the patients will maintain their usual lifestyles for 12 weeks without exercise reminders.
Education and self-exercise: The participants will receive a exercise prescription suggestion. Then, they will maintain their usual lifestyles without exercise reminders.
|
|---|---|---|
|
Change in Exercise Capacity: Anaerobic Threshold (AT) From Baseline to 12 Weeks
|
1.2 ml/kg/min
Standard Deviation 3.4
|
1.0 ml/kg/min
Standard Deviation 3.7
|
PRIMARY outcome
Timeframe: baseline, 12 weeksThe amount of air exhaled (mL) during the first second during a forced expiratory volume test will be measured by spirometry. The change in FEV₁ was calculated as the value at 12 weeks minus the value at baseline. A higher FEV₁ indicates better lung function.
Outcome measures
| Measure |
Home-based Telerehabilitation
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes). Then, the participants will start a home-based telehealth exercise training program (30minutes/session, 3 sessions/week for 12weeks, with a total of 36 sessions) combined with heart rate sensing clothes. Exercise type: brisk walking, jogging, or stationary ergometer exercise.
Home-based telehealth exercise training program: A home-based exercise mobile app will be offered combined with the heart rate sensing clothes to each participant in the group of home-based telehealth exercise training program. The mobile app provides auto-feedback of heart rate at each exercise training session through the heart rate sensing clothes and alarm function identifying individuals' appropriate exercise intensity (target heart rate) during their exercise based on their exercise prescription calculated and set up inside the app. After completing each exercise training session, the record of training time and heart rate response is simultaneously uploaded to the cloud system of the medical center through the heart rate sensing clothes. The experienced and well-trained nurse checked the cloud system data to monitor participants' adherence to exercise training. In addition, online communication is enabled using LINE software, which provided a platform for patients and researchers to interact with each other through messaging.
|
Education and Self-exercise
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes).
Then, the patients will maintain their usual lifestyles for 12 weeks without exercise reminders.
Education and self-exercise: The participants will receive a exercise prescription suggestion. Then, they will maintain their usual lifestyles without exercise reminders.
|
|---|---|---|
|
Change in Lung Function: Forced Expiratory Volume 1 (FEV1) From Baseline to 12 Weeks
|
0.0 liters
Standard Deviation 0.3
|
0.0 liters
Standard Deviation 0.2
|
PRIMARY outcome
Timeframe: baseline, 12 weeksThe total amount of air exhaled (mL) during a forced expiratory volume test will be measured by spirometry. The change in FVC was calculated as the value at 12 weeks minus the value at baseline. A higher FVC indicates better lung function.
Outcome measures
| Measure |
Home-based Telerehabilitation
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes). Then, the participants will start a home-based telehealth exercise training program (30minutes/session, 3 sessions/week for 12weeks, with a total of 36 sessions) combined with heart rate sensing clothes. Exercise type: brisk walking, jogging, or stationary ergometer exercise.
Home-based telehealth exercise training program: A home-based exercise mobile app will be offered combined with the heart rate sensing clothes to each participant in the group of home-based telehealth exercise training program. The mobile app provides auto-feedback of heart rate at each exercise training session through the heart rate sensing clothes and alarm function identifying individuals' appropriate exercise intensity (target heart rate) during their exercise based on their exercise prescription calculated and set up inside the app. After completing each exercise training session, the record of training time and heart rate response is simultaneously uploaded to the cloud system of the medical center through the heart rate sensing clothes. The experienced and well-trained nurse checked the cloud system data to monitor participants' adherence to exercise training. In addition, online communication is enabled using LINE software, which provided a platform for patients and researchers to interact with each other through messaging.
|
Education and Self-exercise
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes).
Then, the patients will maintain their usual lifestyles for 12 weeks without exercise reminders.
Education and self-exercise: The participants will receive a exercise prescription suggestion. Then, they will maintain their usual lifestyles without exercise reminders.
|
|---|---|---|
|
Change in Lung Function: Forced Vital Capacity (FVC) From Baseline to 12 Weeks
|
0.0 liters
Standard Deviation 0.3
|
-0.1 liters
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: baseline, 12 weeksThe measured FEV1 is divided by the measured FVC. he change in FEV₁/FVC was calculated as the value at 12 weeks minus the value at baseline. A higher FEV₁/FVC ratio generally indicates better lung function, while a lower ratio suggests airflow limitation.
Outcome measures
| Measure |
Home-based Telerehabilitation
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes). Then, the participants will start a home-based telehealth exercise training program (30minutes/session, 3 sessions/week for 12weeks, with a total of 36 sessions) combined with heart rate sensing clothes. Exercise type: brisk walking, jogging, or stationary ergometer exercise.
Home-based telehealth exercise training program: A home-based exercise mobile app will be offered combined with the heart rate sensing clothes to each participant in the group of home-based telehealth exercise training program. The mobile app provides auto-feedback of heart rate at each exercise training session through the heart rate sensing clothes and alarm function identifying individuals' appropriate exercise intensity (target heart rate) during their exercise based on their exercise prescription calculated and set up inside the app. After completing each exercise training session, the record of training time and heart rate response is simultaneously uploaded to the cloud system of the medical center through the heart rate sensing clothes. The experienced and well-trained nurse checked the cloud system data to monitor participants' adherence to exercise training. In addition, online communication is enabled using LINE software, which provided a platform for patients and researchers to interact with each other through messaging.
|
Education and Self-exercise
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes).
Then, the patients will maintain their usual lifestyles for 12 weeks without exercise reminders.
Education and self-exercise: The participants will receive a exercise prescription suggestion. Then, they will maintain their usual lifestyles without exercise reminders.
|
|---|---|---|
|
Change in Lung Function: FEV1/FVC % From Baseline to 12 Weeks
|
-1.2 percentage of FEV1/FVC
Standard Deviation 10.9
|
0.7 percentage of FEV1/FVC
Standard Deviation 3.4
|
PRIMARY outcome
Timeframe: baseline, 12 weeksThe ventilation/ perfusion abnormalities (VE/VCO2)is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in VE/VCO2 was calculated as the value at 12 weeks minus the value at baseline. A lower VE/VCO2 ratio indicates better ventilatory efficiency and reduced ventilation/perfusion abnormalities.
Outcome measures
| Measure |
Home-based Telerehabilitation
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes). Then, the participants will start a home-based telehealth exercise training program (30minutes/session, 3 sessions/week for 12weeks, with a total of 36 sessions) combined with heart rate sensing clothes. Exercise type: brisk walking, jogging, or stationary ergometer exercise.
Home-based telehealth exercise training program: A home-based exercise mobile app will be offered combined with the heart rate sensing clothes to each participant in the group of home-based telehealth exercise training program. The mobile app provides auto-feedback of heart rate at each exercise training session through the heart rate sensing clothes and alarm function identifying individuals' appropriate exercise intensity (target heart rate) during their exercise based on their exercise prescription calculated and set up inside the app. After completing each exercise training session, the record of training time and heart rate response is simultaneously uploaded to the cloud system of the medical center through the heart rate sensing clothes. The experienced and well-trained nurse checked the cloud system data to monitor participants' adherence to exercise training. In addition, online communication is enabled using LINE software, which provided a platform for patients and researchers to interact with each other through messaging.
|
Education and Self-exercise
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes).
Then, the patients will maintain their usual lifestyles for 12 weeks without exercise reminders.
Education and self-exercise: The participants will receive a exercise prescription suggestion. Then, they will maintain their usual lifestyles without exercise reminders.
|
|---|---|---|
|
Change in Ventilation/ Perfusion Abnormalities (VE/VCO2) From Baseline to 12 Weeks
|
-0.1 ratio
Standard Deviation 1.7
|
0.8 ratio
Standard Deviation 3.6
|
PRIMARY outcome
Timeframe: baseline, 12 weeksO2 Pulse is simply oxygen consumption (in ml) divided by heart rate. It is used as an index of stroke volume.The O2 pulse is measured by graded exercise testing. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in O₂ pulse was calculated as the value at 12 weeks minus the value at baseline. A higher O₂ pulse indicates improved left ventricular function and greater cardiovascular efficiency.
Outcome measures
| Measure |
Home-based Telerehabilitation
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes). Then, the participants will start a home-based telehealth exercise training program (30minutes/session, 3 sessions/week for 12weeks, with a total of 36 sessions) combined with heart rate sensing clothes. Exercise type: brisk walking, jogging, or stationary ergometer exercise.
Home-based telehealth exercise training program: A home-based exercise mobile app will be offered combined with the heart rate sensing clothes to each participant in the group of home-based telehealth exercise training program. The mobile app provides auto-feedback of heart rate at each exercise training session through the heart rate sensing clothes and alarm function identifying individuals' appropriate exercise intensity (target heart rate) during their exercise based on their exercise prescription calculated and set up inside the app. After completing each exercise training session, the record of training time and heart rate response is simultaneously uploaded to the cloud system of the medical center through the heart rate sensing clothes. The experienced and well-trained nurse checked the cloud system data to monitor participants' adherence to exercise training. In addition, online communication is enabled using LINE software, which provided a platform for patients and researchers to interact with each other through messaging.
|
Education and Self-exercise
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes).
Then, the patients will maintain their usual lifestyles for 12 weeks without exercise reminders.
Education and self-exercise: The participants will receive a exercise prescription suggestion. Then, they will maintain their usual lifestyles without exercise reminders.
|
|---|---|---|
|
Change in Left Ventricular Function: O2 Pulse From Baseline to 12 Weeks
|
0.5 ml/beats
Standard Deviation 1.8
|
0.6 ml/beats
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: baseline, 12 weeksThe heart rate recovery is measured by graded exercise testing, including 1 minute and 2 minute recovery. A cycling ergometer (MGC Ultima CardiO2) is used for cardiopulmonary testing with a incremental ramp protocol (10-W/min). The test will be terminated until patients complained of physical exhaustion or maximal capacity (respiratory exchange ratio (RER) meets 1.2). The change in heart rate recovery was calculated as the difference between heart rate recovery at 12 weeks and heart rate recovery at baseline. A decrease of \< 12 or 22 beats per minute in 1- or 2-min heart rate recovery, respectively, indicates an elevated risk of mortality. A faster heart rate recovery indicates better cardiovascular fitness and autonomic regulation.
Outcome measures
| Measure |
Home-based Telerehabilitation
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes). Then, the participants will start a home-based telehealth exercise training program (30minutes/session, 3 sessions/week for 12weeks, with a total of 36 sessions) combined with heart rate sensing clothes. Exercise type: brisk walking, jogging, or stationary ergometer exercise.
Home-based telehealth exercise training program: A home-based exercise mobile app will be offered combined with the heart rate sensing clothes to each participant in the group of home-based telehealth exercise training program. The mobile app provides auto-feedback of heart rate at each exercise training session through the heart rate sensing clothes and alarm function identifying individuals' appropriate exercise intensity (target heart rate) during their exercise based on their exercise prescription calculated and set up inside the app. After completing each exercise training session, the record of training time and heart rate response is simultaneously uploaded to the cloud system of the medical center through the heart rate sensing clothes. The experienced and well-trained nurse checked the cloud system data to monitor participants' adherence to exercise training. In addition, online communication is enabled using LINE software, which provided a platform for patients and researchers to interact with each other through messaging.
|
Education and Self-exercise
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes).
Then, the patients will maintain their usual lifestyles for 12 weeks without exercise reminders.
Education and self-exercise: The participants will receive a exercise prescription suggestion. Then, they will maintain their usual lifestyles without exercise reminders.
|
|---|---|---|
|
Change in Heart Rate Recovery From Baseline to 12 Weeks
1-min HR recovery
|
1.1 beats
Standard Deviation 5.0
|
1.3 beats
Standard Deviation 10.2
|
|
Change in Heart Rate Recovery From Baseline to 12 Weeks
2-min HR recovery
|
2.3 beats
Standard Deviation 5.3
|
3.2 beats
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: baseline, 12 weeksTaiwan version of the International Physical Activity Questionnaire. The overall physical activity (MET-min/week), vigorous intensity physical activity (MET-min/week), moderate intensity physical activity (MET-min/week), walking (MET-min/week) are measured.
Outcome measures
| Measure |
Home-based Telerehabilitation
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes). Then, the participants will start a home-based telehealth exercise training program (30minutes/session, 3 sessions/week for 12weeks, with a total of 36 sessions) combined with heart rate sensing clothes. Exercise type: brisk walking, jogging, or stationary ergometer exercise.
Home-based telehealth exercise training program: A home-based exercise mobile app will be offered combined with the heart rate sensing clothes to each participant in the group of home-based telehealth exercise training program. The mobile app provides auto-feedback of heart rate at each exercise training session through the heart rate sensing clothes and alarm function identifying individuals' appropriate exercise intensity (target heart rate) during their exercise based on their exercise prescription calculated and set up inside the app. After completing each exercise training session, the record of training time and heart rate response is simultaneously uploaded to the cloud system of the medical center through the heart rate sensing clothes. The experienced and well-trained nurse checked the cloud system data to monitor participants' adherence to exercise training. In addition, online communication is enabled using LINE software, which provided a platform for patients and researchers to interact with each other through messaging.
|
Education and Self-exercise
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes).
Then, the patients will maintain their usual lifestyles for 12 weeks without exercise reminders.
Education and self-exercise: The participants will receive a exercise prescription suggestion. Then, they will maintain their usual lifestyles without exercise reminders.
|
|---|---|---|
|
Change in Physical Activity Amounts: Taiwan Version of the International Physical Activity Questionnaire From Baseline to 12 Weeks
Vigorous PA
|
-13.6 MET-min/week
Standard Deviation 1234
|
302.4 MET-min/week
Standard Deviation 1360
|
|
Change in Physical Activity Amounts: Taiwan Version of the International Physical Activity Questionnaire From Baseline to 12 Weeks
Moderate PA
|
-87.6 MET-min/week
Standard Deviation 4739
|
103.7 MET-min/week
Standard Deviation 1189
|
|
Change in Physical Activity Amounts: Taiwan Version of the International Physical Activity Questionnaire From Baseline to 12 Weeks
Walking behavior
|
-1239 MET-min/week
Standard Deviation 2329
|
406 MET-min/week
Standard Deviation 1205
|
|
Change in Physical Activity Amounts: Taiwan Version of the International Physical Activity Questionnaire From Baseline to 12 Weeks
Total PA
|
-1341 MET-min/week
Standard Deviation 2690
|
812 MET-min/week
Standard Deviation 1643
|
SECONDARY outcome
Timeframe: baseline, 12 weeksQuestionnaire of Self-Efficacy Items. A five-item self-efficacy measure designed to measure confidence in one's ability to persist with exercising in various situations was developed. A five-point scale is used to rate each item : 1 indicates "not at all confident", 2 indicates "little confident" , 3 indicates "confident", 4 indicates "very confident", 5 indicates "strongly confident".
Outcome measures
| Measure |
Home-based Telerehabilitation
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes). Then, the participants will start a home-based telehealth exercise training program (30minutes/session, 3 sessions/week for 12weeks, with a total of 36 sessions) combined with heart rate sensing clothes. Exercise type: brisk walking, jogging, or stationary ergometer exercise.
Home-based telehealth exercise training program: A home-based exercise mobile app will be offered combined with the heart rate sensing clothes to each participant in the group of home-based telehealth exercise training program. The mobile app provides auto-feedback of heart rate at each exercise training session through the heart rate sensing clothes and alarm function identifying individuals' appropriate exercise intensity (target heart rate) during their exercise based on their exercise prescription calculated and set up inside the app. After completing each exercise training session, the record of training time and heart rate response is simultaneously uploaded to the cloud system of the medical center through the heart rate sensing clothes. The experienced and well-trained nurse checked the cloud system data to monitor participants' adherence to exercise training. In addition, online communication is enabled using LINE software, which provided a platform for patients and researchers to interact with each other through messaging.
|
Education and Self-exercise
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes).
Then, the patients will maintain their usual lifestyles for 12 weeks without exercise reminders.
Education and self-exercise: The participants will receive a exercise prescription suggestion. Then, they will maintain their usual lifestyles without exercise reminders.
|
|---|---|---|
|
Change in Confidence Level of Exercise: Questionnaire of Self-Efficacy Items From Baseline to 12 Weeks
|
1.2 score on a scale
Standard Deviation 2.4
|
-1.1 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: baseline, 12 weeksThe Taiwanese version of the WHO Quality of Life-BREF (WHOQOL-BREF) with good validity and reliability includes the globally standardized WHOQOL-BREF with 26 items and an additional two locally developed items, making a total of 28 items. It consists of two single-facet items measuring overall quality of life and general health and four domains, including physical (7 items), psychological (6 items), social (4 items), and environmental (9 items) domains. The two additional items are being respected/accepted facet in the social domain and eating/food facet in the environment domain, respectively. The participants rated all items on a scale of 1-5, with higher scores reflecting a greater quality of life. Domain scores were derived by multiplying the mean of the facet scores within each domain by a scaling factor of 4, resulting in potential domain scores ranging from 4 to 20.
Outcome measures
| Measure |
Home-based Telerehabilitation
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes). Then, the participants will start a home-based telehealth exercise training program (30minutes/session, 3 sessions/week for 12weeks, with a total of 36 sessions) combined with heart rate sensing clothes. Exercise type: brisk walking, jogging, or stationary ergometer exercise.
Home-based telehealth exercise training program: A home-based exercise mobile app will be offered combined with the heart rate sensing clothes to each participant in the group of home-based telehealth exercise training program. The mobile app provides auto-feedback of heart rate at each exercise training session through the heart rate sensing clothes and alarm function identifying individuals' appropriate exercise intensity (target heart rate) during their exercise based on their exercise prescription calculated and set up inside the app. After completing each exercise training session, the record of training time and heart rate response is simultaneously uploaded to the cloud system of the medical center through the heart rate sensing clothes. The experienced and well-trained nurse checked the cloud system data to monitor participants' adherence to exercise training. In addition, online communication is enabled using LINE software, which provided a platform for patients and researchers to interact with each other through messaging.
|
Education and Self-exercise
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes).
Then, the patients will maintain their usual lifestyles for 12 weeks without exercise reminders.
Education and self-exercise: The participants will receive a exercise prescription suggestion. Then, they will maintain their usual lifestyles without exercise reminders.
|
|---|---|---|
|
Change in Health-Related Quality of Life: Taiwan Version of World Health Organization Quality-of-Life Questionnaire From Baseline to 12 Weeks (WHOQOL-BREF)
physical domain
|
0.5 score on a scale
Standard Deviation 1.9
|
0.2 score on a scale
Standard Deviation 2.0
|
|
Change in Health-Related Quality of Life: Taiwan Version of World Health Organization Quality-of-Life Questionnaire From Baseline to 12 Weeks (WHOQOL-BREF)
psychological domain
|
0.4 score on a scale
Standard Deviation 1.8
|
0.1 score on a scale
Standard Deviation 2.7
|
|
Change in Health-Related Quality of Life: Taiwan Version of World Health Organization Quality-of-Life Questionnaire From Baseline to 12 Weeks (WHOQOL-BREF)
social domain
|
0.3 score on a scale
Standard Deviation 1.5
|
0.3 score on a scale
Standard Deviation 2.4
|
|
Change in Health-Related Quality of Life: Taiwan Version of World Health Organization Quality-of-Life Questionnaire From Baseline to 12 Weeks (WHOQOL-BREF)
environment domain
|
0.2 score on a scale
Standard Deviation 1.2
|
0.2 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a l-month time interval. Nineteen individual items generate seven "component" scores and the sum of scores for these seven components yields one global score. (Scores ranged from 0 to 21, with higher scores indicating poor sleep quality.)
Outcome measures
| Measure |
Home-based Telerehabilitation
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes). Then, the participants will start a home-based telehealth exercise training program (30minutes/session, 3 sessions/week for 12weeks, with a total of 36 sessions) combined with heart rate sensing clothes. Exercise type: brisk walking, jogging, or stationary ergometer exercise.
Home-based telehealth exercise training program: A home-based exercise mobile app will be offered combined with the heart rate sensing clothes to each participant in the group of home-based telehealth exercise training program. The mobile app provides auto-feedback of heart rate at each exercise training session through the heart rate sensing clothes and alarm function identifying individuals' appropriate exercise intensity (target heart rate) during their exercise based on their exercise prescription calculated and set up inside the app. After completing each exercise training session, the record of training time and heart rate response is simultaneously uploaded to the cloud system of the medical center through the heart rate sensing clothes. The experienced and well-trained nurse checked the cloud system data to monitor participants' adherence to exercise training. In addition, online communication is enabled using LINE software, which provided a platform for patients and researchers to interact with each other through messaging.
|
Education and Self-exercise
n=91 Participants
After graded exercise testing, the participants will receive a single, individual, face-to-face physical activity promotion counseling session (15-20minutes).
Then, the patients will maintain their usual lifestyles for 12 weeks without exercise reminders.
Education and self-exercise: The participants will receive a exercise prescription suggestion. Then, they will maintain their usual lifestyles without exercise reminders.
|
|---|---|---|
|
Change in Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) From Baseline to 12 Weeks
|
0.9 score on a scale
Standard Deviation 2.3
|
0.7 score on a scale
Standard Deviation 3.0
|
Adverse Events
Home-based Telerehabilitation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Education and Self-exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place