Clinical trial NCT05205460: Telerehabilitation in People With Long COVID
Official title: Effectiveness of a 12-week Telerehabilitation Training in People With Long COVID: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Post-COVID
Telerehabilitation
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 182
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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 telerehabilitation among Post-COVID patients. Thus, we want to investigate the effectiveness of telerehabilitation among Post-COVID patients, including cardiorespiratory fitness, physical activity amounts, health related quality of life and sleep quality.

Eligibility criteria: 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
* 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

Primary outcomes:
measure: Change in Exercise Capacity: Peak Oxygen Uptake (VO2peak) From Baseline to 12 Weeks
timeFrame: Baseline, 12 weeks
measure: Change in Exercise Capacity: Workload (Watt) From Baseline to 12 Weeks
timeFrame: baseline, 12 weeks
measure: Change in Exercise Capacity: Anaerobic Threshold (AT) From Baseline to 12 Weeks
timeFrame: baseline, 12 weeks
measure: Change in Lung Function: Forced Expiratory Volume 1 (FEV1) From Baseline to 12 Weeks
timeFrame: baseline, 12 weeks
measure: Change in Lung Function: Forced Vital Capacity (FVC) From Baseline to 12 Weeks
timeFrame: baseline, 12 weeks
measure: Change in Lung Function: FEV1/FVC % From Baseline to 12 Weeks
timeFrame: baseline, 12 weeks
measure: Change in Ventilation/ Perfusion Abnormalities (VE/VCO2) From Baseline to 12 Weeks
timeFrame: baseline, 12 weeks
measure: Change in Left Ventricular Function: O2 Pulse From Baseline to 12 Weeks
timeFrame: baseline, 12 weeks
measure: Change in Heart Rate Recovery From Baseline to 12 Weeks
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Change in Physical Activity Amounts: Taiwan Version of the International Physical Activity Questionnaire From Baseline to 12 Weeks
timeFrame: baseline, 12 weeks
measure: Change in Confidence Level of Exercise: Questionnaire of Self-Efficacy Items From Baseline to 12 Weeks
timeFrame: baseline, 12 weeks
measure: Change in Health-Related Quality of Life: Taiwan Version of World Health Organization Quality-of-Life Questionnaire From Baseline to 12 Weeks (WHOQOL-BREF)
timeFrame: baseline, 12 weeks
measure: Change in Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) From Baseline to 12 Weeks
timeFrame: baseline, 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-service general hospital
state: Neihu
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General
name: Shang-Lin Chiang, PhD
role: PRINCIPAL_INVESTIGATOR
References: