RehabilitationNCT04935437
Implementing a Rehabilitation Program in Patients Recovering From Covid-19 Infection
A study testing Supervised rehabilitation program. in people with Rehabilitation, run by Evangelismos Hospital at 1 site in Greece.
Trial summary
Implementation of a supervised rehabilitation program in patients recovering from COVID-19-infection who suffer from limitations and symptoms due to the disease 6 to 8 weeks from hospital discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rehabilitation
- What is being tested?
- Supervised rehabilitation program.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteGreece
- Study dates
- 21 Jan 2021to 26 Feb 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
None listed.
Who cannot join
- Patients who suffer from active disease will not be included until they stop being infectious.
- Patients treated with COVID-19 infection where the main reason for hospitalization was not the virus infection (e.g. due to coronary heart disease, surgery, etc.) will also be excluded.
- Patients suffering from dementia,
- patients with myocarditis
- patients with thromboembolic disease that receive anticoagulants for less than a month
- patients chronically paralyzed,
Show all 11Show fewer
- patients with paraplegia,
- patients with multiple injuries
- patients with serious orthopedic problems that cause disability
- patients suffering from very serious underlying diseases such as end-stage cancer,
- patients with neurological diseases that cause disability, require rehabilitation clinics and special interventions (speech therapy, kinesiotherapy, patients with tracheostomy etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Implementation of a supervised rehabilitation program in patients recovering from COVID-19-infection who suffer from limitations and symptoms due to the disease 6 to 8 weeks from hospital discharge. Patients who have been seriously ill and have been admitted to the ward with high oxygen mixtures or have been admitted to the ICU will be selected primarily. The program includes supervised rehabilitation sessions 2 times a week for 2 months. Patients will be evaluated during recruitment and at the end of the program. Patients who can not attend the program due to logistical/transport issues will be re-evaluated in 2 months and constitute the control population. Investigators hypothesis is that post COVID-19 patients who have persistent symptoms, including fatigue following a supervised rehabilitation program will have fewer symptoms after the end of the program compared to similar patients who do not attend a rehabilitation program.
- Conditions
- Rehabilitation
- Being tested
- Supervised rehabilitation program.
- Keywords
- Rehabilitation, post COVID-19 sequalae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised rehabilitation program.Other
The program includes aerobic exercise, strengthening exercises, physiotherapy, psychological support and dietary advice.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | The patients in this arm will be enrolled in a 2 months supervised rehabilitation program. Evaluation will take place at recruitment time and at the end of the program (2 months). Receives: Other: Supervised rehabilitation program. |
| Control | No intervention | The patients in this arm will not be enrolled in a supervised rehabilitation program. Evaluation will take place at recruitment and at 2 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of fatigue with FACIT fatigue Scale
The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). Score range is from 0-52 and the higher the score the better QOL (quality of life).
Measured: 2 months
Assessment of fatigue using chalder fatigue scale.
The chalder fatigue scale is scored bimodally with a range from 0 to 11 assessing the number of symptoms. It is also scored in Likert style with a range of 0-33 in order to asses the severity of symptoms. The higher the scores indicate more and more severe symptoms.
Measured: 2 months
Assessment of fatigue with Fatigue Severity Scale
Assessment of fatigue using the Fatigue Severity Scale. The minimum score is 9 and maximum score is 63. Higher values mean higher fatigue severity.
Measured: 2 months
Assessment of respiratory symptoms after COVID-19 with CAT.
Assessment of symptoms after COVID-19 using the COPD Assessment Test (CAT). Minimum score is 0 and maximum score is 40. Patients with higher scores are more impaired. Patients with a score of 10 or more are considered significantly impaired after COVID-19 infection.
Measured: 2 months
Secondary outcomes (17)
Assessment of quality of life using SF-36 questionnaire.
The RAND 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Measured: 2 months
Assessment of shortness of breath
Assessment of shortness of breath using the modified MRC scale. The minimum score is 0 and maximum score is 4. Higher values mean more dyspnea.
Measured: 2 months
Assessment of functional capacity with 6MWT.
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: 2 months
Assessment of symptoms after COVID-19 with PCFS.
Assessment of symptoms after COVID-19 using the Post-COVID-19 Functional Status scale (PCFSS). Minimum score is 0 and maximum score is 4. Patients with higher scores are more impaired. Patients with a score of 2 or more are considered significantly impaired after COVID-19 infection.
Measured: 2 months
Assessment of lower extremity strength
Assessment of lower extremity strength using a dynamometer.
Measured: 2 months.
Assessment of functional capacity with one minute sit to stand test.
The one minute sit to stand test assesses functional lower extremity strength, transitional movements, balance, and fall risk.The 1-minute STS test is performed with a chair of standard height of 46 cm without arm rests. The patient is ensured to be seated upright on the chair positioned against a wall. The patient sits with the knees and hips flexed to 90°, feet placed flat on the floor hip-width apart, and the hands placed on the hips. Every get up from the chair is validated to check if complete sit-to-stand-to-sit sequence is achieved. The number of repetitions is measured.
Measured: 2 months
Assessment of functional capacity with Short Physical Performance Battery.
Short Physical Performance Battery is a simple test to measure lower extremity function using tasks that mimic daily activities. The SPPB examines 3 areas of lower extremity function; static balance, gait speed, and getting in and out of a chair. SPPB scores range from zero to 12 possible points, a score lower than 10 indicates one or more mobility limitations
Measured: 2 months
Assessment of Post Traumatic Stress Disorder with the Impact of Event Scale revised.
The Impact of Event Scale - Revised (IES-R) is designed as a measure of post-traumatic stress disorder (PTSD) symptoms. It's a 22-item self report measure that assesses subjective distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales.
Measured: 2 months
Assessment of anxiety and depression with HADS
The Hospital Anxiety and Depression Scale (HADS) measures anxiety and depression in a general medical population of patients. HADS focuses on non-physical symptoms so that it can be used to diagnose depression and/or anxiety in people with significant physical ill-health.The questionnaire comprises seven questions for anxiety and seven questions for depression.
For both scales, scores of less than 7 indicate non-cases 8-10 Mild 11-14 Moderate 15-21 Severe
Measured: 2 months
Assessment of lung diffusion capacity.
Assessment of lung diffusion capacity through measurement of diffusing capacity of the lung for carbon monoxide (CO) (DLCO)
Measured: 2 months
Assessment of respiratory function with FVC
Assessment of respiratory function measuring Forced Vital Capacity with spirometry.
Measured: 2 months
Assessment of quality of life using EQ-5D-5L questionnaire.
The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Measured: 2 months
Assessment of physical activity with IPAQ.
International Physical Activity Questionnaire (IPAQ) is 27 item self report measure of physical activity for adults 15 to 69 years old. There two forms of output from scoring the IPAQ, in categories (low, moderate and high activity), or as continuous variables as MET minutes per week. MET minutes represent the amount of energy expended carrying out physical activity. The higher the score the more active the participant.
Measured: 2 months
Assessment of balance.
The Activities-Specific Balance Confidence (ABC) scale is used. Patients give their answers in % of confidence and score ranges from 0% (worst possible balance confidence) to 100% .
Measured: 2 months
Assessment of respiratory function with FEV1
Assessment of respiratory function measuring Forced Expiratory Volume in 1 minute with spirometry.
Measured: 2 months
Assessment of cognitive dysfunction
The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment. The MoCA test is a one-page 30-point test, scores range between 0 and 30. A score of 26 or over is considered to be normal.
Measured: 2 months
Assessment of depression with Beck Depression Inventory
The Beck Depression Inventory (BDI, BDI-1A, BDI-II), is a 21-question multiple-choice self-report inventory for measuring the severity of depression.
When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows:
0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start21 Jan 2021
- Primary completion1 Aug 2021
- Study completion26 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Before and after trial matched cohort trial.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evangelismos Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Asimakos, Evangelismos Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935437
- Sponsor's protocol ID
- 21-1-2021 22
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2021
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spruit MA, Holland AE, Singh SJ, Tonia T, Wilson KC, Troosters T. COVID-19: interim guidance on rehabilitation in the hospital and post-hospital phase from a European Respiratory Society- and American Thoracic Society-coordinated international task force. Eur Respir J. 2020 Dec 3;56(6):2002197. doi: 10.1183/13993003.02197-2020. Print 2020 Dec.
PubMed 32817258Sally Singh, Charlotte Bolton, Claire Nolan, Theresa Harvey-Dunstan, Bronwen Connolly, William Man and Paul Walker. Delivering rehabilitation to patients surviving COVID-19 using an adapted pulmonary rehabilitation approach - BTS guidance [Internet]. British Thoracic Society; 2020. Available from: https://www.brit-thoracic.org.uk/document-library/quality-improvement/covid-19/pulmonary-rehabilitation-for-covid-19-patients/
Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.
PubMed 33428867Daynes E, Gerlis C, Briggs-Price S, Jones P, Singh SJ. COPD assessment test for the evaluation of COVID-19 symptoms. Thorax. 2021 Feb;76(2):185-187. doi: 10.1136/thoraxjnl-2020-215916. Epub 2020 Nov 4.
PubMed 33148809Klok FA, Boon GJAM, Barco S, Endres M, Geelhoed JJM, Knauss S, Rezek SA, Spruit MA, Vehreschild J, Siegerink B. The Post-COVID-19 Functional Status scale: a tool to measure functional status over time after COVID-19. Eur Respir J. 2020 Jul 2;56(1):2001494. doi: 10.1183/13993003.01494-2020. Print 2020 Jul.
PubMed 32398306
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Rehabilitation Program in Patients Recovering From Covid-19 Infection
- ClinicalTrials.gov ID
- NCT04935437
- Acronym / sponsor ID
- 21-1-2021 22
- Conditions
- Rehabilitation
- Keywords
- Rehabilitation, post COVID-19 sequalae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Evangelismos HospitalUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 26 Feb 2022 (actual)
- First posted
- 23 Jun 2021 (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.
Implementation of a supervised rehabilitation program in patients recovering from COVID-19-infection who suffer from limitations and symptoms due to the disease 6 to 8 weeks from hospital discharge. Patients who have been seriously ill and have been admitted to the ward with high oxygen mixtures or have been admitted to the ICU will be selected primarily. The program includes supervised rehabilitation sessions 2 times a week for 2 months. Patients will be evaluated during recruitment and at the end of the program. Patients who can not attend the program due to logistical/transport issues will be re-evaluated in 2 months and constitute the control population. Investigators hypothesis is that post COVID-19 patients who have persistent symptoms, including fatigue following a supervised rehabilitation program will have fewer symptoms after the end of the program compared to similar patients who do not attend a rehabilitation program.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before and after trial matched cohort trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Supervised rehabilitation program.The patients in this arm will be enrolled in a 2 months supervised rehabilitation program. Evaluation will take place at recruitment time and at the end of the program (2 months). |
| Control | No intervention | –The patients in this arm will not be enrolled in a supervised rehabilitation program. Evaluation will take place at recruitment and at 2 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Patients who suffer from active disease will not be included until they stop being infectious.
- Patients treated with COVID-19 infection where the main reason for hospitalization was not the virus infection (e.g. due to coronary heart disease, surgery, etc.) will also be excluded.
- Patients suffering from dementia,
- patients with myocarditis
- patients with thromboembolic disease that receive anticoagulants for less than a month
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 |
|---|---|---|
| Supervised rehabilitation program.The program includes aerobic exercise, strengthening exercises, physiotherapy, psychological support and dietary advice. | Other | Intervention |
Primary outcome
Assessment of fatigue with FACIT fatigue Scale
Time frame: 2 months
The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). Score range is from 0-52 and the higher the score the better QOL (quality of life).
Assessment of fatigue using chalder fatigue scale.
Time frame: 2 months
The chalder fatigue scale is scored bimodally with a range from 0 to 11 assessing the number of symptoms. It is also scored in Likert style with a range of 0-33 in order to asses the severity of symptoms. The higher the scores indicate more and more severe symptoms.
Assessment of fatigue with Fatigue Severity Scale
Time frame: 2 months
Assessment of fatigue using the Fatigue Severity Scale. The minimum score is 9 and maximum score is 63. Higher values mean higher fatigue severity.
Assessment of respiratory symptoms after COVID-19 with CAT.
Time frame: 2 months
Assessment of symptoms after COVID-19 using the COPD Assessment Test (CAT). Minimum score is 0 and maximum score is 40. Patients with higher scores are more impaired. Patients with a score of 10 or more are considered significantly impaired after COVID-19 infection.
17 secondary outcomes
Assessment of quality of life using SF-36 questionnaire.
Time frame: 2 months
Assessment of shortness of breath
Time frame: 2 months
Assessment of functional capacity with 6MWT.
Time frame: 2 months
Assessment of symptoms after COVID-19 with PCFS.
Time frame: 2 months
Assessment of lower extremity strength
Time frame: 2 months.
Assessment of functional capacity with one minute sit to stand test.
Time frame: 2 months
Assessment of functional capacity with Short Physical Performance Battery.
Time frame: 2 months
Assessment of Post Traumatic Stress Disorder with the Impact of Event Scale revised.
Time frame: 2 months
Assessment of anxiety and depression with HADS
Time frame: 2 months
Assessment of lung diffusion capacity.
Time frame: 2 months
Assessment of respiratory function with FVC
Time frame: 2 months
Assessment of quality of life using EQ-5D-5L questionnaire.
Time frame: 2 months
Assessment of physical activity with IPAQ.
Time frame: 2 months
Assessment of balance.
Time frame: 2 months
Assessment of respiratory function with FEV1
Time frame: 2 months
Assessment of cognitive dysfunction
Time frame: 2 months
Assessment of depression with Beck Depression Inventory
Time frame: 2 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 8 Jun 2022.
- Background: PubMed 32817258Spruit MA, Holland AE, Singh SJ, Tonia T, Wilson KC, Troosters T. COVID-19: interim guidance on rehabilitation in the hospital and post-hospital phase from a European Respiratory Society- and American Thoracic Society-coordinated international task force. Eur Respir J. 2020 Dec 3;56(6):2002197. doi: 10.1183/13993003.02197-2020. Print 2020 Dec.
- BackgroundSally Singh, Charlotte Bolton, Claire Nolan, Theresa Harvey-Dunstan, Bronwen Connolly, William Man and Paul Walker. Delivering rehabilitation to patients surviving COVID-19 using an adapted pulmonary rehabilitation approach - BTS guidance [Internet]. British Thoracic Society; 2020. Available from: https://www.brit-thoracic.org.uk/document-library/quality-improvement/covid-19/pulmonary-rehabilitation-for-covid-19-patients/
- Background: PubMed 33428867Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.
- Background: PubMed 33148809Daynes E, Gerlis C, Briggs-Price S, Jones P, Singh SJ. COPD assessment test for the evaluation of COVID-19 symptoms. Thorax. 2021 Feb;76(2):185-187. doi: 10.1136/thoraxjnl-2020-215916. Epub 2020 Nov 4.
- Background: PubMed 32398306Klok FA, Boon GJAM, Barco S, Endres M, Geelhoed JJM, Knauss S, Rezek SA, Spruit MA, Vehreschild J, Siegerink B. The Post-COVID-19 Functional Status scale: a tool to measure functional status over time after COVID-19. Eur Respir J. 2020 Jul 2;56(1):2001494. doi: 10.1183/13993003.01494-2020. Print 2020 Jul.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised rehabilitation program. in people with Rehabilitation, run by Evangelismos Hospital at 1 site in Greece.
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 0 inclusion and 11 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 8 Jun 2022. 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 Greece. 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?
Assessment of fatigue with FACIT fatigue Scale (time frame: 2 months). The study lists 4 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 NCT04935437, which also lists 5 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 8 Jun 2022.