Tele-rehabilitation Versus Home Exercise Program in COVID-19
NCT ID: NCT04482634
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
122 participants
INTERVENTIONAL
2020-09-01
2022-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Pulmonary rehabilitation is a comprehensive intervention consists of assessment of patient, exercise training and education in order to improve physical and psychological condition of people with chronic respiratory disease.
The patients with COVID-19 with post-intensive care syndrome will be randomized two groups: Tele-rehabilitation group and home exercise group. There will not be a non-exercising control group due to the ethical issues. The exercise program of both groups will be prescribed by a physiatrist based on the physical examination and the functional capacity of the patients.
Tele-rehabilitation group will perform the exercise program 3 days/week for 10 weeks. One session will include aerobic, flexibility and strengthening exercises for lower and upper extremity and breathing exercise.
The trainings will start with low-intensity exercises and intensity and duration of the exercises will progress according to the condition of the patient.
Intensity of the exercises will be monitored by Borg scale based on dyspnea and exertion symptoms during the sessions.
Home exercise group will perform the exercises at their home on their own, 3 days/week for 10 weeks. The patients will be trained about the individualised exercise program as the first session provided at the hospital. The physiotherapist will call the patients weekly, modifications in the exercise program will be made according to the patient's reports.
Outcomes will be measured at baseline, within 1 week of completion the program, 6th months and 12th months following the rehabilitation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tele-rehabilitation group
This group will perform the exercises at their home under remote supervision of a physiotherapist via internet connection.
Remote controlled exercise
Breathing, aerobic, posture, stretching, upper and lower extremity strengthening exercises.
Home exercise group
This group will perform the exercises at their home on their own, the first exercise program will be given at hospital and the patients will be followed up regular weekly by phone call.
Home exercise
Breathing, aerobic, posture, stretching, upper and lower extremity strengthening exercises.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Remote controlled exercise
Breathing, aerobic, posture, stretching, upper and lower extremity strengthening exercises.
Home exercise
Breathing, aerobic, posture, stretching, upper and lower extremity strengthening exercises.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* To be discharged from ICU with a diagnosis of ARDS or severe pneumonia due to COVID-19
* To have ability to walk independently
Exclusion Criteria
* To have a severe co-morbidity that exercise is contraindicated
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Koç University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ozden Ozyemisci Taskiran, Prof
Role: PRINCIPAL_INVESTIGATOR
Koc University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Koc University School of Medicine
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Held N, Moss M. Optimizing Post-Intensive Care Unit Rehabilitation. Turk Thorac J. 2019 Apr 1;20(2):147-152. doi: 10.5152/TurkThoracJ.2018.18172. Print 2019 Apr.
Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.
Lau HM, Ng GY, Jones AY, Lee EW, Siu EH, Hui DS. A randomised controlled trial of the effectiveness of an exercise training program in patients recovering from severe acute respiratory syndrome. Aust J Physiother. 2005;51(4):213-9. doi: 10.1016/s0004-9514(05)70002-7.
Bourne S, DeVos R, North M, Chauhan A, Green B, Brown T, Cornelius V, Wilkinson T. Online versus face-to-face pulmonary rehabilitation for patients with chronic obstructive pulmonary disease: randomised controlled trial. BMJ Open. 2017 Jul 17;7(7):e014580. doi: 10.1136/bmjopen-2016-014580.
Turan Z, Ozyemisci Taskiran O, Erden Z, Kokturk N, Kaymak Karatas G. Does hand grip strength decrease in chronic obstructive pulmonary disease exacerbation? A cross-sectional study. Turk J Med Sci. 2019 Jun 18;49(3):802-808. doi: 10.3906/sag-1811-22.
Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.
Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321-7. doi: 10.1164/ajrccm/145.6.1321.
Bergland A, Jorgensen L, Emaus N, Strand BH. Mobility as a predictor of all-cause mortality in older men and women: 11.8 year follow-up in the Tromso study. BMC Health Serv Res. 2017 Jan 10;17(1):22. doi: 10.1186/s12913-016-1950-0.
Beaudart C, McCloskey E, Bruyere O, Cesari M, Rolland Y, Rizzoli R, Araujo de Carvalho I, Amuthavalli Thiyagarajan J, Bautmans I, Bertiere MC, Brandi ML, Al-Daghri NM, Burlet N, Cavalier E, Cerreta F, Cherubini A, Fielding R, Gielen E, Landi F, Petermans J, Reginster JY, Visser M, Kanis J, Cooper C. Sarcopenia in daily practice: assessment and management. BMC Geriatr. 2016 Oct 5;16(1):170. doi: 10.1186/s12877-016-0349-4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020.219.IRB1.069
Identifier Type: -
Identifier Source: org_study_id