Telerehabilitation in People With Long COVID

NCT05205460 | Completed Results DMC

• 1 other identifier: A202105159
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to investigate the effectiveness of telerehabilitation in Post-COVID patients.

Conditions

COVID-19

Keywords

Post-COVID; Telerehabilitation

Outcome Measures

Primary Outcomes (9)

• Change in Exercise Capacity: Peak Oxygen Uptake (VO2peak) From Baseline to 12 Weeks

  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.

  Baseline, 12 weeks

• Change in Exercise Capacity: Workload (Watt) From Baseline to 12 Weeks

  The 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.

  baseline, 12 weeks

• Change in Exercise Capacity: Anaerobic Threshold (AT) From Baseline to 12 Weeks

  The 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.

  baseline, 12 weeks

• Change in Lung Function: Forced Expiratory Volume 1 (FEV1) From Baseline to 12 Weeks

  The 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.

  baseline, 12 weeks

• Change in Lung Function: Forced Vital Capacity (FVC) From Baseline to 12 Weeks

  The 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.

  baseline, 12 weeks

• Change in Lung Function: FEV1/FVC % From Baseline to 12 Weeks

  The 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.

  baseline, 12 weeks

• Change in Ventilation/ Perfusion Abnormalities (VE/VCO2) From Baseline to 12 Weeks

  The 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.

  baseline, 12 weeks

• Change in Left Ventricular Function: O2 Pulse From Baseline to 12 Weeks

  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 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.

  baseline, 12 weeks

• Change in Heart Rate Recovery From Baseline to 12 Weeks

  The 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.

  baseline, 12 weeks

Secondary Outcomes (4)

• Change in Physical Activity Amounts: Taiwan Version of the International Physical Activity Questionnaire From Baseline to 12 Weeks

  baseline, 12 weeks

• Change in Confidence Level of Exercise: Questionnaire of Self-Efficacy Items From Baseline to 12 Weeks

  baseline, 12 weeks

• Change in Health-Related Quality of Life: Taiwan Version of World Health Organization Quality-of-Life Questionnaire From Baseline to 12 Weeks (WHOQOL-BREF)

  baseline, 12 weeks

• Change in Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) From Baseline to 12 Weeks

  baseline, 12 weeks

Study Arms (2)

Home-based telerehabilitation

EXPERIMENTAL

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.

Device: Home-based telerehabilitation

Education and self-exercise

ACTIVE COMPARATOR

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.

Behavioral: Education and self-exercise

Interventions

Home-based telerehabilitation DEVICE

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.

Home-based telerehabilitation

Education and self-exercise BEHAVIORAL

The participants will receive a exercise prescription suggestion. Then, they will maintain their usual lifestyles without exercise reminders.

Education and self-exercise

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• able to walk including those who need the walking aid
• had mobile phones and could easily access the Internet

You may not qualify if:

• 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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-service general hospital

Taipei, Neihu, 11490, Taiwan

Location

Related Publications (1)

• Lai CY, Lin CH, Chao TC, Lin CH, Chang CC, Huang CY, Chiang SL. Effectiveness of a 12-week telerehabilitation training in people with long COVID: A randomized controlled trial. Ann Phys Rehabil Med. 2024 Jun;67(5):101853. doi: 10.1016/j.rehab.2024.101853. Epub 2024 Jun 1.

  PMID: 38824899 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Chia-Ying Lai
• Organization: Tri-service general hospital

pokerface165@gmail.com

87923311

Study Officials

• Shang-Lin Chiang, PhD

  Department of Physical Medicine and Rehabilitation, Tri-Service General

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: January 25, 2022
• Study Start: October 12, 2021
• Primary Completion: April 30, 2023
• Study Completion: May 20, 2023
• Last Updated: March 11, 2025
• Results First Posted: March 11, 2025

Record last verified: 2025-02

Locations

TW (1)