Covid19NCT04402983
The Effectiveness of Telerehabilitation-Based Physiotherapy in COVID 19 Patients
A study testing Physiotherapy in people with Covid19 and Telerehabilitation, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength can be observed in individuals who have been diagnosed with COVID19 and have been discharged. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19, Telerehabilitation, Physical Therapy
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 May 2020to 1 Dec 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-75
- Being diagnosed with COVID19 and being discharged by being treated
- Having technological facilities suitable for telerehabilitation access
Who cannot join
- Any presence of comorbidity that may prevent them from exercising
- Not agreeing to be included in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Turkey
Istanbul, 34668
About this study
Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength can be observed in individuals who have been diagnosed with COVID19 and have been discharged. In our study, it was aimed to investigate the effect of telerehabilitation physical therapy intervention to these cases by using videoconferencing method on the physical condition of the cases.
Read the detailed description
Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength can be observed in individuals who have been diagnosed with COVID19 and have been discharged. In our study, it was aimed to investigate the effect of telerehabilitation physical therapy intervention to these cases by using videoconferencing method on the physical condition of the cases. The exercise program will be a total of 6 weeks, 3 days a week. Online access will be carried out synchronously by telephone or computer, and training sessions will not be recorded in order to protect patient personal information. The cases will be evaluated online at the beginning of the study and at the end of the 6-week exercise program. The selected evaluation parameters have been selected considering the ease of online application.
- Conditions
- Covid19, Telerehabilitation, Physical Therapy
- Being tested
- Physiotherapy
- Keywords
- exercise, videoconference
- Medical subject headings
- COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Program content Respiratory exercise (chest breathing, diaphragmatic breathing, basal expansion exercises), Breath control training, Active breathing techniques cycle Light aerobic exercise Posture exercises Self walking
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Group | Experimental | Physiotherapy will be carried out by conducting online conference method. Program content; Respiratory exercise (chest breathing, diaphragmatic breathing, basal expansion exercises), Breath control training, Active breathing techniques cycle Light aerobic exercise Posture exercises Self walking Receives: Other: Physiotherapy |
| Control group | No intervention | Information and exercise brochure will be provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Medical Research Council Dyspnea Score
The mMRC Dyspnea Scale is best used to establish baseline functional impairment due to dyspnea attributable to respiratory disease; tracking the mMRC over time or with therapeutic interventions is of less certain clinical utility.The severity of dyspnea is rated on a scale of 0 to 4. "O" means no dyspnea perception, "4" means severe dyspnea perception.
Measured: Baseline to 6 weeks
Timed up and go test
The Timed "Up and Go" (TUG) Test measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down.
Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more.
Clinical guide: <10 seconds = normal <20 seconds = good mobility, can go out alone, mobile without a gait aid <30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate high risk of falls.
Measured: Baseline to 6 weeks
Visual analog scale to assess the pain severity
Visual analog scale to assess the pain on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) score.
Measured: Baseline to 6 weeks
The Short Physical Performance Battery (SPPB)
The Short Physical Performance Battery (SPPB) is comprised of 3 tasks: a standing balance test (side by side, semi-tandem and tandem), a 4-m habitual gait speed, and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 points. The total score is 12 points and this represents the highest performance. It can be easily performed at home via video conferencing
Measured: Baseline to 6 weeks
Visual analog scale to assess the fatigue severity
Visual analog scale to assess the fatigue severity on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) score.
Measured: Baseline to 6 weeks
Secondary outcomes (2)
BECK depression inventory
This is a 21-item self-assessment scale designed by Aaron Beck in 1961 to measure the risk and level of depression.
Measured: Baseline to 6 weeks
Saint George Respiratory Questionnaire
The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start27 May 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esra pehlivan, Saglik Bilimleri Universitesi
- Investigators
- Esra Pehlivan, PhD, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402983
- Sponsor's protocol ID
- Telerehab_Covid19
- Status last verified
- May 2020
- First submitted
- 22 May 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pehlivan E, Palali I, Atan SG, Turan D, Cinarka H, Cetinkaya E. The effectiveness of POST-DISCHARGE telerehabilitation practices in COVID-19 patients: Tele-COVID study-randomized controlled trial. Ann Thorac Med. 2022 Apr-Jun;17(2):110-117. doi: 10.4103/atm.atm_543_21. Epub 2022 Apr 19.
PubMed 35651892
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Telerehabilitation-Based Physiotherapy in COVID 19 Patients
- ClinicalTrials.gov ID
- NCT04402983
- Acronym / sponsor ID
- Telerehab_Covid19
- Conditions
- Covid19, Telerehabilitation, Physical Therapy
- Keywords
- exercise, videoconference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 27 May 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.
Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength can be observed in individuals who have been diagnosed with COVID19 and have been discharged. In our study, it was aimed to investigate the effect of telerehabilitation physical therapy intervention to these cases by using videoconferencing method on the physical condition of the cases.
Detailed description
Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength can be observed in individuals who have been diagnosed with COVID19 and have been discharged. In our study, it was aimed to investigate the effect of telerehabilitation physical therapy intervention to these cases by using videoconferencing method on the physical condition of the cases. The exercise program will be a total of 6 weeks, 3 days a week. Online access will be carried out synchronously by telephone or computer, and training sessions will not be recorded in order to protect patient personal information. The cases will be evaluated online at the beginning of the study and at the end of the 6-week exercise program. The selected evaluation parameters have been selected considering the ease of online application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Group | Experimental | Other: PhysiotherapyPhysiotherapy will be carried out by conducting online conference method. Program content; Respiratory exercise (chest breathing, diaphragmatic breathing, basal expansion exercises), Breath control training, Active breathing techniques cycle Light aerobic exercise Posture exercises Self walking |
| Control group | No intervention | –Information and exercise brochure will be provided |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between the ages of 18-75
- Being diagnosed with COVID19 and being discharged by being treated
- Having technological facilities suitable for telerehabilitation access
Key exclusion criteria (2 listed)
- Any presence of comorbidity that may prevent them from exercising
- Not agreeing to be included in the study
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 |
|---|---|---|
| PhysiotherapyProgram content Respiratory exercise (chest breathing, diaphragmatic breathing, basal expansion exercises), Breath control training, Active breathing techniques cycle Light aerobic exercise Posture exercises Self walking | Other | Telerehabilitation Group |
Primary outcome
Modified Medical Research Council Dyspnea Score
Time frame: Baseline to 6 weeks
The mMRC Dyspnea Scale is best used to establish baseline functional impairment due to dyspnea attributable to respiratory disease; tracking the mMRC over time or with therapeutic interventions is of less certain clinical utility.The severity of dyspnea is rated on a scale of 0 to 4. "O" means no dyspnea perception, "4" means severe dyspnea perception.
Timed up and go test
Time frame: Baseline to 6 weeks
The Timed "Up and Go" (TUG) Test measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down. Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more. Clinical guide: <10 seconds = normal <20 seconds = good mobility, can go out alone, mobile without a gait aid <30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate high risk of falls.
Visual analog scale to assess the pain severity
Time frame: Baseline to 6 weeks
Visual analog scale to assess the pain on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) score.
The Short Physical Performance Battery (SPPB)
Time frame: Baseline to 6 weeks
The Short Physical Performance Battery (SPPB) is comprised of 3 tasks: a standing balance test (side by side, semi-tandem and tandem), a 4-m habitual gait speed, and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 points. The total score is 12 points and this represents the highest performance. It can be easily performed at home via video conferencing
Visual analog scale to assess the fatigue severity
Time frame: Baseline to 6 weeks
Visual analog scale to assess the fatigue severity on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) score.
2 secondary outcomes
BECK depression inventory
Time frame: Baseline to 6 weeks
Saint George Respiratory Questionnaire
Time frame: Baseline to 6 weeks
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 14 Dec 2020.
- Derived from this study: PubMed 35651892Pehlivan E, Palali I, Atan SG, Turan D, Cinarka H, Cetinkaya E. The effectiveness of POST-DISCHARGE telerehabilitation practices in COVID-19 patients: Tele-COVID study-randomized controlled trial. Ann Thorac Med. 2022 Apr-Jun;17(2):110-117. doi: 10.4103/atm.atm_543_21. Epub 2022 Apr 19.
- Individual participant dataSharing planned: Undecided
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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.
Esra Pehlivan, PhD principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Covid19 and Telerehabilitation, run by Istanbul Medipol University Hospital 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 14 Dec 2020. 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?
Modified Medical Research Council Dyspnea Score (time frame: Baseline to 6 weeks). The study lists 5 primary outcomes in all. 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 NCT04402983, which also lists 1 linked publication.
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 14 Dec 2020.