Covid19NCT04791072
Tele-coaching in Patients With COVID-19
A study testing Exercise in people with Covid19 and Rehabilitation, run by Izmir Katip Celebi University.
Trial summary
Respiratory exercise training and aerobic exercise training will be given to patients who have been hospitalized in intensive care due to COVID 19 and underwent IMV, who were hospitalized in the service and underwent NIMV or high-flow oxygen inhalation, and whose respiratory symptoms persist after discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Rehabilitation
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Mar 2021
- 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
- Being treated in intensive care unit due to COVID-19 pneumonia,
- Receiving IMV, NIMV, or high-flow oxygen therapy
- Patients whose respiratory symptoms persist despite discharge
Who cannot join
- Patients with PCR test +
- Patients without any complaints.
- Patients who are hospitalized and discharged within 10 days
- Patients with orthopedic, neurological, cognitive problems
About this study
Official title: Effectiveness of Pulmonary Rehabilitation With Tele-coaching in Patients With COVID-19
Respiratory exercise training and aerobic exercise training will be given to patients who have been hospitalized in intensive care due to COVID 19 and underwent IMV, who were hospitalized in the service and underwent NIMV or high-flow oxygen inhalation, and whose respiratory symptoms persist after discharge. The patients in the study group will be called by phone once a week and a motivating conversation will be made. No control will be made to the control group. Before and after the training, 6-minute walking test, MRC dyspnea scale, SGRQ quality of life questionnaire and hospital anxiety depression scale will be applied.
Read the detailed description
Some of the patients with COVID 19 pneumonia still have respiratory symptoms despite being treated. It has been reported that pulmonary rehabilitation programs applied in various models and in a small number to relieve or reduce these symptoms reduce dyspnea, increase exercise capacity and improve quality of life. There is no study reporting the results of a pulmonary rehabilitation program applied to COVID 19 patients in our country. The main purpose of this study is to determine the efficacy of pulmonary rehabilitation applied by telecoach to patients with severe COVID 19 pneumonia or persistent respiratory symptoms. Secondly, it is aimed to present the data of Turkish society to the literature. In accordance with this purpose investigators planed a randomised control clinical study. In our study respiratory exercise training and aerobic exercise training will be given to patients who have been hospitalized in intensive care due to COVID 19 and underwent IMV, who were hospitalized in the service and underwent NIMV or high-flow oxygen inhalation, and whose respiratory symptoms persist after discharge. The patients in the study group will be called by phone once a week and a motivating conversation will be made. No control will be made to the control group. Before and after the training, 6-minute walking test, MRC dyspnea scale, SGRQ quality of life questionnaire and hospital anxiety depression scale will be applied.
- Conditions
- Covid19, Rehabilitation
- Being tested
- Exercise
- Keywords
- covid19, rehabilitation, telecoaching
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Breathing exercise training Use of incentive spirometry Aerobic exercise training Strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Telecoaching group | Experimental | They will be given breathing exercise training and will be asked to do it every day for 8 weeks. In addition to breathing exercises, the use of incentive spirometry and aerobic exercise training will be provided. They will be asked to do breathing exercises, use of incentive spirometry and strengthening exercises for at least 20 minutes every day and 5 times a week. They will be called by phone once a week and encouraging speeches will be made. Receives: Other: Exercise |
| Control Group | Active comparator | They will be given breathing exercise training and will be asked to do it every day. In addition to breathing exercises, the use of incentive spirometry and aerobic exercise training will be provided. They will be asked to do breathing exercises, use of incentive spirometry and strengthening exercises for at least 20 minutes every day and 5 times a week. There will be no interviews in the control group. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
Six Minute- walk test
Measured: Change from baseline six minute walk distance at 8 week
Secondary outcomes (3)
Dyspnea Assessment
Medical Research Council Scale(MRC); the MRC dyspnea scale is a questionnaire that consists of five statements about perceived breathlessness. (min 1- max 5 point) Higher scores mean a worse outcome.
Measured: Change from baseline dyspnea at 8 week
Quality of Life Assessment
St. George Respiratory Questionnaire; Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: Change from baseline quality of life at 8 week
Anxiety and Depression
Hospital Anxiety and Depression (HAD); The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
Measured: Change from baseline anxiety and depression at 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Naz, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791072
- Sponsor's protocol ID
- IKCSS
- Status last verified
- Mar 2021
- First submitted
- 27 Feb 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sahin H, Naz I, Karadeniz G, Sunecli O, Polat G, Ediboglu O. Effects of a home-based pulmonary rehabilitation program with and without telecoaching on health-related outcomes in COVID-19 survivors: a randomized controlled clinical study. J Bras Pneumol. 2023 Jan 23;49(1):e20220107. doi: 10.36416/1806-3756/e20220107. eCollection 2023.
PubMed 36700571
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pulmonary Rehabilitation With Tele-coaching in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04791072
- Acronym / sponsor ID
- IKCSS
- Conditions
- Covid19, Rehabilitation
- Keywords
- covid19, rehabilitation, telecoaching
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 10 Mar 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.
Respiratory exercise training and aerobic exercise training will be given to patients who have been hospitalized in intensive care due to COVID 19 and underwent IMV, who were hospitalized in the service and underwent NIMV or high-flow oxygen inhalation, and whose respiratory symptoms persist after discharge. The patients in the study group will be called by phone once a week and a motivating conversation will be made. No control will be made to the control group. Before and after the training, 6-minute walking test, MRC dyspnea scale, SGRQ quality of life questionnaire and hospital anxiety depression scale will be applied.
Detailed description
Some of the patients with COVID 19 pneumonia still have respiratory symptoms despite being treated. It has been reported that pulmonary rehabilitation programs applied in various models and in a small number to relieve or reduce these symptoms reduce dyspnea, increase exercise capacity and improve quality of life. There is no study reporting the results of a pulmonary rehabilitation program applied to COVID 19 patients in our country. The main purpose of this study is to determine the efficacy of pulmonary rehabilitation applied by telecoach to patients with severe COVID 19 pneumonia or persistent respiratory symptoms. Secondly, it is aimed to present the data of Turkish society to the literature. In accordance with this purpose investigators planed a randomised control clinical study. In our study respiratory exercise training and aerobic exercise training will be given to patients who have been hospitalized in intensive care due to COVID 19 and underwent IMV, who were hospitalized in the service and underwent NIMV or high-flow oxygen inhalation, and whose respiratory symptoms persist after discharge. The patients in the study group will be called by phone once a week and a motivating conversation will be made. No control will be made to the control group. Before and after the training, 6-minute walking test, MRC dyspnea scale, SGRQ quality of life questionnaire and hospital anxiety depression scale will be applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telecoaching group | Experimental | Other: ExerciseThey will be given breathing exercise training and will be asked to do it every day for 8 weeks. In addition to breathing exercises, the use of incentive spirometry and aerobic exercise training will be provided. They will be asked to do breathing exercises, use of incentive spirometry and strengthening exercises for at least 20 minutes every day and 5 times a week. They will be called by phone once a week and encouraging speeches will be made. |
| Control Group | Active comparator | Other: ExerciseThey will be given breathing exercise training and will be asked to do it every day. In addition to breathing exercises, the use of incentive spirometry and aerobic exercise training will be provided. They will be asked to do breathing exercises, use of incentive spirometry and strengthening exercises for at least 20 minutes every day and 5 times a week. There will be no interviews in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being treated in intensive care unit due to COVID-19 pneumonia,
- Receiving IMV, NIMV, or high-flow oxygen therapy
- Patients whose respiratory symptoms persist despite discharge
Key exclusion criteria (4 listed)
- Patients with PCR test +
- Patients without any complaints.
- Patients who are hospitalized and discharged within 10 days
- Patients with orthopedic, neurological, cognitive problems
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 |
|---|---|---|
| ExerciseBreathing exercise training Use of incentive spirometry Aerobic exercise training Strengthening exercises | Other | Control Group, Telecoaching group |
Primary outcome
Exercise Capacity
Time frame: Change from baseline six minute walk distance at 8 week
Six Minute- walk test
3 secondary outcomes
Dyspnea Assessment
Time frame: Change from baseline dyspnea at 8 week
Quality of Life Assessment
Time frame: Change from baseline quality of life at 8 week
Anxiety and Depression
Time frame: Change from baseline anxiety and depression at 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 36700571Sahin H, Naz I, Karadeniz G, Sunecli O, Polat G, Ediboglu O. Effects of a home-based pulmonary rehabilitation program with and without telecoaching on health-related outcomes in COVID-19 survivors: a randomized controlled clinical study. J Bras Pneumol. 2023 Jan 23;49(1):e20220107. doi: 10.36416/1806-3756/e20220107. eCollection 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Covid19 and Rehabilitation, run by Izmir Katip Celebi University.
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 4 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: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Exercise Capacity (time frame: Change from baseline six minute walk distance at 8 week). 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 NCT04791072, 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 10 Mar 2021.