Pulmonary RehabilitationNCT04482634
Tele-rehabilitation Versus Home Exercise Program in COVID-19
A study testing Home exercise in people with Pulmonary Rehabilitation and COVID-19, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate the potential effects of face-to-face supervised tele-rehabilitation to home exercise program on walking speed, handgrip strength, muscle endurance, quality of life, physical activity level and perceived respiratory disability in COVID-19 patients who hospitalized in ICU due to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Rehabilitation, COVID-19
- What is being tested?
- Home exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be older than 18 years
- To be discharged from ICU with a diagnosis of ARDS or severe pneumonia due to COVID-19
- To have ability to walk independently
Who cannot join
- To have dementia or cognitive impairment, symptomatic psychiatric illness, hearing or visual impairment that might interfere to follow the instructions
- To have a severe co-morbidity that exercise is contraindicated
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Koc University School of Medicine
Istanbul, 34010
About this study
Official title: Is Tele-rehabilitation Superior to Home Exercise Program in the Pulmonary Rehabilitation of the Patients With COVID-19 With Post-intensive Care Syndrome? A Randomized Controlled Trial
The aim of the study is to investigate the potential effects of face-to-face supervised tele-rehabilitation to home exercise program on walking speed, handgrip strength, muscle endurance, quality of life, physical activity level and perceived respiratory disability in COVID-19 patients who hospitalized in ICU due to ARDS and discharged from hospital.
Read the detailed description
COVID-19 could cause respiratory distress in a minority of cases and requires intensive care and mechanical ventilation. When patients recover and are discharged from hospital, physical, cognitive and emotional complications known as post-intensive care syndrome is seen in the majority of patients and requires rehabilitation.
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
- Pulmonary Rehabilitation, COVID-19
- Being tested
- Remote controlled exercise, Home exercise
- Keywords
- pulmonary rehabilitation, COVID-19, pulmonary exercise, post-intensive care syndrome
- Medical subject headings
- COVID-19, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote controlled exerciseOther
Breathing, aerobic, posture, stretching, upper and lower extremity strengthening exercises.
Home exerciseOther
Breathing, aerobic, posture, stretching, upper and lower extremity strengthening exercises.
| Study group | Role | What they receive |
|---|---|---|
| Tele-rehabilitation group | Active comparator | This group will perform the exercises at their home under remote supervision of a physiotherapist via internet connection. Receives: Other: Remote controlled exercise |
| Home exercise group | Active comparator | 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. Receives: Other: Home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
This is a field test evaluating submaximal aerobic capacity. The individuals are asked to walk as far as possible in a 30-meter corridor in 6 minutes. The technical standards are defined by European Respiratory Society and American Thoracic Society. Six-minute walking distance will be recorded. Higher walking distance shows better outcome. Minimal clinical difference is 20-30 meter in patients surviving acute respiratory distress syndrome
Measured: 12 months
Secondary outcomes (7)
Short form - 36
Short form - 36 measures health related quality of life. It is a self-reported survey that evaluates individual health status with eight parameters consisting of physical function, pain, role limitations attributed to physical problems, role limitations attributed to emotional problems, mental health, social functioning, energy/ vitality, general health perception. There is not a summary score, each section is scored between 0-100, 0 indicates the worst condition, 100 indicates the best.
Measured: 12 months
Chair- stand test
Chair stand test will be used to evaluate strength and endurance of lower limbs. Patients will be asked to sit on a chair by crossing their hands over their chest and sit five times consecutively as fast as possible. The test will be started in the sitting position and terminated at the last standing position and the time will be recorded. The test will be carried out 2 times and the best grade obtained will be recorded
Measured: 12 months
Timed up and go test
To assess physical function/performance, timed up and go test will be performed. It is an objective, reliable and simple test to evaluate balance and functional movement. The patient will be asked to get up from a chair, walk 3 m, turn around, walk back and sit on the chair again. The time will be recorded in seconds. The test will be started and ended when the patient sit on the chair with back supported. It predicts mortality.
Measured: 12 months
St. George's Respiratory Questionnaire
St. George's Respiratory Questionnaire is a 50-item questionnaire with 76 weighted responses that is developed to measure health status/ quality of life in patients with airway diseases. It consists of 3 sections; symptoms (8 item), activity (16 item) and impact of the disease (26 item). Each of the 3 sections is scored separately and a summary total score is calculated using weights attached to each item in the range 0 to 100. 0 indicates best possible health status and 100 indicates worst possible health status. A minimum change in score of 4 units was established as clinically relevant. Turkish reliability of the questionnaire is exist.
Measured: 12 months
The COPD Assessment Test
The COPD Assessment Test evaluates 8 parameters for measuring the impact of COPD on a patient's life and how changes over time. It provides a scoring range of 0-40, higher score indicates worst health. Turkish validity and reliability of the test is exist.
Measured: 12 months
Medical Research Council Dyspnea Scale
The Medical Research Council Dyspnea Scale is a simple method measuring perceived respiratory disability of COPD patients. It consists of 5 items from 0 to 4. 0 indicates normal, 4 indicates worst.
Measured: 12 months
Hand grip strength
Hand grip strength is an indicator of overall muscle strength that predicts mortality in older patients and correlates with 6 minute walk distance in subjects with COPD exacerbation. Handgrip strength will be measured using a handheld dynamometer (JAMAR Plus+ electronic dynamometer, part number: 563213, serial number: 2019070814) according to the instructions of the American Society of Hand Therapists. Patients will be seated placing their arms by their sides with the elbow flexed to 90°, the forearm mid-prone, and the wrist in neutral position. Patients will be asked to grip the dynamometer with maximally to measure maximal grip strength (in kg) for the dominant hand with standard verbal encouragement. Three trials will be performed with a 30 sec rest between trials and the highest value will be recorded. The cut-off values of grip strength are 28.6 kg in men and 16.4 kg in women.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Sep 2020
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pulmonary RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two groups. The first group will perform the exercises at their home under remote supervision (tele-rehabilitation group) and the second group will perform the exercises at their home on their own (home exercise group)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ozden Ozyemisci Taskiran, Prof, Principal investigator, Koc University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482634
- Sponsor's protocol ID
- 2020.219.IRB1.069
- Status last verified
- May 2022
- First submitted
- 21 Jul 2020
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30958989Spruit 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.
PubMed 24127811Lau 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.
PubMed 16321128Bourne 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.
PubMed 28716786Turan 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.
PubMed 31190519Bestall 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.
PubMed 10377201Jones 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.
PubMed 19720809Jones 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.
PubMed 1595997Bergland 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.
PubMed 28068995Beaudart 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.
PubMed 27716195
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Tele-rehabilitation Superior to Home Exercise Program in the Pulmonary Rehabilitation of the Patients With COVID-19 With Post-intensive Care Syndrome? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04482634
- Acronym / sponsor ID
- 2020.219.IRB1.069
- Conditions
- Pulmonary Rehabilitation, COVID-19
- Keywords
- pulmonary rehabilitation, COVID-19, pulmonary exercise, post-intensive care syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate the potential effects of face-to-face supervised tele-rehabilitation to home exercise program on walking speed, handgrip strength, muscle endurance, quality of life, physical activity level and perceived respiratory disability in COVID-19 patients who hospitalized in ICU due to ARDS and discharged from hospital.
Detailed description
COVID-19 could cause respiratory distress in a minority of cases and requires intensive care and mechanical ventilation. When patients recover and are discharged from hospital, physical, cognitive and emotional complications known as post-intensive care syndrome is seen in the majority of patients and requires rehabilitation.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There will be two groups. The first group will perform the exercises at their home under remote supervision (tele-rehabilitation group) and the second group will perform the exercises at their home on their own (home exercise group)
| Arm | Type | Receives |
|---|---|---|
| Tele-rehabilitation group | Active comparator | Other: Remote controlled exerciseThis group will perform the exercises at their home under remote supervision of a physiotherapist via internet connection. |
| Home exercise group | Active comparator | Other: Home exerciseThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be older than 18 years
- To be discharged from ICU with a diagnosis of ARDS or severe pneumonia due to COVID-19
- To have ability to walk independently
Key exclusion criteria (2 listed)
- To have dementia or cognitive impairment, symptomatic psychiatric illness, hearing or visual impairment that might interfere to follow the instructions
- To have a severe co-morbidity that exercise is contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote controlled exerciseBreathing, aerobic, posture, stretching, upper and lower extremity strengthening exercises. | Other | Tele-rehabilitation group |
| Home exerciseBreathing, aerobic, posture, stretching, upper and lower extremity strengthening exercises. | Other | Home exercise group |
Primary outcome
6-minute walk test
Time frame: 12 months
This is a field test evaluating submaximal aerobic capacity. The individuals are asked to walk as far as possible in a 30-meter corridor in 6 minutes. The technical standards are defined by European Respiratory Society and American Thoracic Society. Six-minute walking distance will be recorded. Higher walking distance shows better outcome. Minimal clinical difference is 20-30 meter in patients surviving acute respiratory distress syndrome
7 secondary outcomes
Short form - 36
Time frame: 12 months
Chair- stand test
Time frame: 12 months
Timed up and go test
Time frame: 12 months
St. George's Respiratory Questionnaire
Time frame: 12 months
The COPD Assessment Test
Time frame: 12 months
Medical Research Council Dyspnea Scale
Time frame: 12 months
Hand grip strength
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Results publication: PubMed 30958989Held 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.
- Results publication: PubMed 24127811Spruit 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.
- Results publication: PubMed 16321128Lau 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.
- Results publication: PubMed 28716786Bourne 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.
- Results publication: PubMed 31190519Turan 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.
- Results publication: PubMed 10377201Bestall 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.
- Results publication: PubMed 19720809Jones 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.
- Results publication: PubMed 1595997Jones 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.
- Results publication: PubMed 28068995Bergland 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.
- Results publication: PubMed 27716195Beaudart 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.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Rehabilitation
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
Recruiting
Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD
COPD (Chronic Obstructive Pulmonary Disease)
RecruitingObservational study
Changes in Energy Expenditure in Response to Physical Activity in Healthy Adults
Physical Activities
Not yet recruiting
Effects of Respiratory Muscle Strength Training in Children With Asthma
Asthma (Diagnosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozden Ozyemisci Taskiran, Prof principal investigator
Koc University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home exercise in people with Pulmonary Rehabilitation and COVID-19, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04482634, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.