Clinical trial NCT05305638: Tele-Rehabilitation in Individuals With Covid-19
Official title: Investigation of the Effect of Telerehabilitation-Based Physiotherapy Training on Respiration, Quality of Life, Physical Activity and Fatigue in Individuals With Covid-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Covid-19
Breathing
Quality of Life
Physical Activity
Fatigue
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Coronavirus Disease (COVID-19) is a respiratory disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-cov-2). This study was planned as a single-blind randomized controlled pilot study to compare the effectiveness of telerehabilitation-based exercise training applied to individuals with Covid-19. Individuals will be divided into two groups, the control group and the study group. All assessments will be made online twice, before and after treatment. Socio-demographic data of individuals who agreed to participate in the study, disease information about Covid-19, MRC Dyspnea Scale, COVID-19 Fear Scale, International Physical Activity Questionnaire-Short Form, ST. George Respiratory Questionnaire, Fatigue Severity Scale, Nottingham Health Profile will be questioned and recorded. The obtained data will be analyzed with statistical methods.


Eligibility criteria: Inclusion Criteria:

* A score in the range of 0-3 on the MRC Dyspnea Scale.
* Not have any vestibular, orthopedic or neurological disease that will affect muscle strength, balance and coordination.
* Not having undergone surgery in the last 6 months.
* Not having undergone any surgical procedure that may affect the musculoskeletal system of the spinal column, lower extremities or upper extremities.
* It was being cooperative and volunteering.

Exclusion Criteria:

* Severe liver and kidney disease or new and progressive damage to liver and kidney function, deep vein thrombosis and pulmonary embolism, suspected aortic stenosis, having a disease/condition for which exercise is contraindicated.

Primary outcomes:
measure: The Fear of COVID-19 Scale
timeFrame: baseline to 6 week after
measure: MRC Dyspnea Scale
timeFrame: baseline
measure: International Physical Activity Questionnaire-Short Form
timeFrame: baseline to 6 week after
measure: St. George's Respiratory Questionnaire, SGRQ
timeFrame: baseline to 6 week after
measure: Fatigue Severity Scale
timeFrame: baseline to 6 week after
measure: Nottingham Health Profile
timeFrame: baseline to 6 week after
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Emine Nur Demircan, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun J, He WT, Wang L, Lai A, Ji X, Zhai X, Li G, Suchard MA, Tian J, Zhou J, Veit M, Su S. COVID-19: Epidemiology, Evolution, and Cross-Disciplinary Perspectives. Trends Mol Med. 2020 May;26(5):483-495. doi: 10.1016/j.molmed.2020.02.008. Epub 2020 Mar 21.
citation: MS AG, N.; Surendran, P.; Jacob, P.; Karpouzis, V.; Haneef, M.; Aleef, M.; Ali, S.; Praveen, R.; Bouguerra, E.; Almudahka,. Acute Care Physiotherapy Management of COVID-19 Patients in Qatar: Best Practice Recommendations. Preprints. 2020.
citation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
citation: Gattinoni L, Coppola S, Cressoni M, Busana M, Rossi S, Chiumello D. COVID-19 Does Not Lead to a "Typical" Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2020 May 15;201(10):1299-1300. doi: 10.1164/rccm.202003-0817LE. No abstract available.