Telehealth Exercise Training in Post-COVID Patients

COVID-19 Clinical Trial

Official title:

Effectiveness of Home-based Telehealth Exercise Training Program for Post-COVID Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05205460
• Other study ID #: A202105159
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: October 8, 2024

Study information

• Verified date: November 2023
• Source: Tri-Service General Hospital
• Contact: Chia-Ying Lai, MD
• Phone: 886-2-87923311
• Email: pokerface165[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of our study is to investigate the effectiveness of telehealth exercise training programs in Post-COVID patients.

Description:

Decreased exercise capacity, persistent dyspnea and easily fatigue are found in some Post-COVID patients. Telerehabilitation has been developed in cardiac and pulmonary diseases such as coronary artery disease and chronic obstructive pulmonary disease for years with good clinical outcomes. However, little is known about the effectiveness of home-based telehealth exercise training programs among Post-COVID patients. Thus, we want to investigate the effectiveness of telehealth exercise training programs among Post-COVID patients, including exercise capacity, physical amounts and health related quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 8, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

Individuals who had been diagnosed with COVID-19 positive and whose last PCR test or rapid

antigen test was negative with the following criteria:

• aged between 20 to 80 years old
• persistent symptoms at least 4 weeks after recovery from COVID-19 infection, including any of the following symptoms: dyspnea, fatigue, cough, headache, chest tightness, palpitations, loss of smell, anxiety, insomnia, brain fog or joint pain
• able to speak and understand Mandarin
• no cognitive impairment (Mini-Mental State Examination > 24)
• able to walk including those who need the walking aid
• had mobile phones and could easily access the Internet

Exclusion Criteria:

• a history of chronic obstructive pulmonary disease or other respiratory diseases
• a history of arrhythmia,cancer, end-stage renal disease with dialysis, being diagnosed with mental illness, recent stroke within 6 months
• inability to participate because of comorbid neurological or musculoskeletal conditions that produce moderate to severe physical disability
• need all day oxygen support

Related Conditions & MeSH terms

• COVID-19

Intervention

Device:
• 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.

Behavioral:
• Education and self-exercise
The participants will receive a exercise prescription suggestion. Then, they will maintain their routine outpatient follow-up per month and usual lifestyles with weekly reminders.

Locations

Country	Name	City	State
Taiwan	Tri-service general hospital	Taipei	Neihu

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in exercise capacity: peak oxygen uptake (VO2peak)	The peak oxygen uptake (VO2peak) is measured by graded exercise testing. A motorized ergometer bike (Ergoselect 200 K, Ergoline, Germany) 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).	3 months
Primary	Change in exercise capacity: workload (Watt)	The workload (Watt) is measured by graded exercise testing. A motorized ergometer bike (Ergoselect 200 K, Ergoline, Germany) 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).	3 months
Primary	Change in exercise capacity: anaerobic threshold (AT)	The anaerobic threshold (AT) is measured by graded exercise testing. A motorized ergometer bike (Ergoselect 200 K, Ergoline, Germany) 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).	3 months
Secondary	Change in Physical Activity Amounts: Taiwan version of the International Physical Activity Questionnaire	Taiwan 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), and sitting behavior (min/week) are measured.	3 months
Secondary	Change in confidence level of exercise: Questionnaire of Self-Efficacy Items	Questionnaire 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".	3 months
Secondary	Change in Health-Related Quality of Life: Taiwan version of World Health Organization Quality-of-Life Questionnaire (WHOQOL-BREF)	The WHOQOL-BREF Taiwan version is simplified from the WHOQOL long form for Taiwan. It contains 28 items. ( 26 items organized into 4 domains, and 2 items on overall quality of life and general health) The 4 domains are Physical Health, Psychological, Social Relationships and Environment. Three negatively phrased items are reversed scored. Domain scores are computed by taking the mean of the scores of the items that constitute the domain and multiplied by 4 so that the scores are directly comparable with those derived from WHOQOL-100.	3 months
Secondary	Change in sleep quality: Pittsburgh Sleep Quality Index (PSQI)	Pittsburgh 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.)	3 months
Secondary	Change in lung function: Forced expiratory volume 1 (FEV1)	The amount of air exhaled (mL) during the first second during a forced expiratory volume test will be measured by spirometry.	3 months
Secondary	Change in lung function: Forced Vital Capacity (FVC)	The total amount of air exhaled (mL) during a forced expiratory volume test will be measured by spirometry.	3 months
Secondary	Change in lung function: FEV1/FVC %	The measured FEV1 is divided by the measured FVC.	3 months
Secondary	Change in lung function: Total lung capacity	Total lung capacity (TLC) is the maximum volume of air the lungs can hold and is measured by lung plethysmography.	3 months
Secondary	Change in ventilation/ perfusion abnormalities (VE/VCO2)	The ventilation/ perfusion abnormalities (VE/VCO2)is measured by graded exercise testing.; A motorized ergometer bike (Ergoselect 200 K, Ergoline, Germany) 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).	3 months
Secondary	Change in left ventricular function: O2 pulse	O2 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 motorized ergometer bike (Ergoselect 200 K, Ergoline, Germany) 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).	3 months
Secondary	Change in heart rate recovery	The heart rate recovery is measured by graded exercise testing, including 1 minute and 2 minute recovery.; A motorized ergometer bike (Ergoselect 200 K, Ergoline, Germany) 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).	3 months
Secondary	Change in maximal heart rate (HRmax)	The maximal heart rate is measured by graded exercise testing, including 1 minute and 2 minute recovery. A motorized ergometer bike (Ergoselect 200 K, Ergoline, Germany) 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).	3 months
Secondary	Change in maximal blood pressure (BPmax)	The maximal heart rate is measured by graded exercise testing, including 1 minute and 2 minute recovery.; A motorized ergometer bike (Ergoselect 200 K, Ergoline, Germany) 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).	3 months