COVID-19NCT07000331
Effectiveness of Exercise and Physical Activity in Individuals.
A study testing Thoracic expansion exercises and Physical activity counseling in people with COVID-19, run by Gulsah Bargi at 1 site in Turkey (Türkiye).
Trial summary
The effects of breathing exercises and physical activity counseling applied for 4 weeks on the number of daily steps, dyspnea, pain, fatigue, mood and quality of life in individuals who have just had COVID-19 are not yet known. For this reason, it was aimed to investigate in this study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Thoracic expansion exercises and Physical activity counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2023to 30 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult individuals aged 18 and over who volunteered to participate in the research
- Individuals who can understand and answer surveys
- Compatible individuals who can perform exercises and have good cooperation.
- Individuals who were diagnosed with COVID-19 (individuals with a positive Polymerase Chain Reaction (PCR) test result, compatible with COVID-19 infection as a result of lung X-ray or lung tomography despite negative PCR test results) and discharged after recovery/home quarantine completed
Who cannot join
- Individuals newly diagnosed with COVID-19, therefore in quarantine at home or receiving treatment in hospital
- Individuals with suspected COVID-19
- Pregnant women
- Individuals with serious psychiatric illness and therefore unable to adapt to exercise sessions
- Individuals with severe cognitive impairment
- Individuals with ongoing orthopedic, neurological, cardiovascular disorders and/or problems which are independent of COVID-19
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Breathing Exercises and Physical Activity Counseling in Individuals Who Have Had COVID-19.
The effects of breathing exercises and physical activity counseling applied for 4 weeks on the number of daily steps, dyspnea, pain, fatigue, mood and quality of life in individuals who have just had COVID-19 are not yet known. For this reason, it was aimed to investigate in this study.
Read the detailed description
In the COVID-19 pandemic, which deepened the physical inactivity and sedentary lifestyle, the severity and mortality effect of the virus on humans has decreased today. On the other hand, some symptoms may continue to be seen after recovery in individuals who survived COVID-19. It is known that regular physical activities increase immunity and quality of life, reduce stress, anxiety and depression, and support the musculoskeletal and cardiovascular systems. This study aimed to search effects of breathing exercises and physical activity counseling on the step counts, dyspnea, pain, fatigue, mood and quality of life in individuals with post-COVID-19.
- Conditions
- COVID-19
- Being tested
- Thoracic expansion exercises, Physical activity counseling
- Keywords
- physical activity, dyspnea, pain, fatigue, anxiety, depression, quality of life
- Medical subject headings
- COVID-19, Motor Activity, Dyspnea, Pain, Fatigue, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic expansion exercisesOther
Individuals placed their hands on their lower ribs and then took 3 deep breaths under their hands in a row. After this cycle, individuals rested by taking 3-4 calm breaths. The cycle was repeated 10 times. The individual did this session 4 times a day.
Physical activity counselingOther
Individuals were given weekly group phone calls and meetings. Individuals were gradually accustomed to regular walking to increase their daily step count. In the first week, individuals were asked to walk a total of 30-45 minutes per day, at least 4-5 days per week, and to increase the number of steps measured at the beginning by approximately 1000-2000 steps per day to reach at least 6500 steps. In the second week, the expected goal was at least 7500 steps. In the third and fourth weeks, they were asked to reach at least 10000 steps.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | The individuals in the study group were given thoracic expansion exercises and physical activity counseling. Receives: Other: Thoracic expansion exercises; Other: Physical activity counseling |
| Control group | No intervention | Individuals in this group continued their normal daily living activities and were followed up only with follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily step counts
Daily average step counts were recorded via a pedometer.
Measured: Baseline, at the end of everyday during 4-week and at 4 weeks after baseline evaluation
Secondary outcomes (6)
Anxiety score
The score was obtained from Hospital Anxiety and Depression Scale.The lowest score on this scale is 0 and the highest is 21, with higher scores indicating increased anxiety.
Measured: Baseline and at 4 weeks after baseline evaluation
Depression score
The score was obtained from Hospital Anxiety and Depression Scale.The lowest score on this scale is 0 and the highest is 21, with higher scores indicating increased anxiety.
Measured: Baseline and at 4 weeks after baseline evaluation
Dyspnea score
The score was obtained from Medical Research Council Dyspnea Scale.The lowest score on this scale is 0 and the highest is 4; higher scores indicate increased dyspnea.
Measured: Baseline and at 4 weeks after baseline evaluation
Pain score
The score was obtained from Numerical Rating Scale.The lowest score on this scale is 0 and the highest is 10, with higher scores indicating increased pain.
Measured: Baseline and at 4 weeks after baseline evaluation
Fatigue score
The score was obtained from Numerical Rating Scale.The lowest score on this scale is 0 and the highest is 10, with higher scores indicating increased fatigue.
Measured: Baseline and at 4 weeks after baseline evaluation
Quality of life score
The score was obtained from Short-Form (SF)-36 Quality of life Questionnaire.The lowest score on this scale is 0 and the highest is 100, with higher scores indicating higher quality of life.
Measured: Baseline and at 4 weeks after baseline evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2025
- Study start16 Feb 2023
- Primary completion30 Aug 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulsah Bargi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gulsah Bargi, Izmir Democracy University
- Investigators
- GÜLŞAH BARĞI, Assoc. Dr., Study director, Izmir Democracy UniversitySENA UYGUNLAR, Principal investigator, Izmir Democracy UniversityGÜLCAN POLAT, Principal investigator, Izmir Democracy UniversityDİLAN SU AKTAŞ, Principal investigator, Izmir Democracy UniversityUĞUR CANBULAT, Principal investigator, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000331
- Sponsor's protocol ID
- Exercise in post-COVID-19
- Status last verified
- Jun 2025
- First submitted
- 30 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang TJ, Chau B, Lui M, Lam GT, Lin N, Humbert S. Physical Medicine and Rehabilitation and Pulmonary Rehabilitation for COVID-19. Am J Phys Med Rehabil. 2020 Sep;99(9):769-774. doi: 10.1097/PHM.0000000000001505.
PubMed 32541352Amini H, Isanejad A, Chamani N, Movahedi-Fard F, Salimi F, Moezi M, Habibi S. Physical activity during COVID-19 pandemic in the Iranian population: A brief report. Heliyon. 2020 Nov;6(11):e05411. doi: 10.1016/j.heliyon.2020.e05411. Epub 2020 Nov 2.
PubMed 33163638
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Breathing Exercises and Physical Activity Counseling in Individuals Who Have Had COVID-19.
- ClinicalTrials.gov ID
- NCT07000331
- Acronym / sponsor ID
- Exercise in post-COVID-19
- Conditions
- COVID-19
- Keywords
- physical activity, dyspnea, pain, fatigue, anxiety, depression, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Gulsah BargiUniversity, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 2 Jun 2025 (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 effects of breathing exercises and physical activity counseling applied for 4 weeks on the number of daily steps, dyspnea, pain, fatigue, mood and quality of life in individuals who have just had COVID-19 are not yet known. For this reason, it was aimed to investigate in this study.
Detailed description
In the COVID-19 pandemic, which deepened the physical inactivity and sedentary lifestyle, the severity and mortality effect of the virus on humans has decreased today. On the other hand, some symptoms may continue to be seen after recovery in individuals who survived COVID-19. It is known that regular physical activities increase immunity and quality of life, reduce stress, anxiety and depression, and support the musculoskeletal and cardiovascular systems. This study aimed to search effects of breathing exercises and physical activity counseling on the step counts, dyspnea, pain, fatigue, mood and quality of life in individuals with post-COVID-19.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Thoracic expansion exercises, Other: Physical activity counselingThe individuals in the study group were given thoracic expansion exercises and physical activity counseling. |
| Control group | No intervention | –Individuals in this group continued their normal daily living activities and were followed up only with follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult individuals aged 18 and over who volunteered to participate in the research
- Individuals who can understand and answer surveys
- Compatible individuals who can perform exercises and have good cooperation.
- Individuals who were diagnosed with COVID-19 (individuals with a positive Polymerase Chain Reaction (PCR) test result, compatible with COVID-19 infection as a result of lung X-ray or lung tomography despite negative PCR test results) and discharged after recovery/home quarantine completed
Key exclusion criteria (6 listed)
- Individuals newly diagnosed with COVID-19, therefore in quarantine at home or receiving treatment in hospital
- Individuals with suspected COVID-19
- Pregnant women
- Individuals with serious psychiatric illness and therefore unable to adapt to exercise sessions
- Individuals with severe cognitive impairment
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 |
|---|---|---|
| Thoracic expansion exercisesIndividuals placed their hands on their lower ribs and then took 3 deep breaths under their hands in a row. After this cycle, individuals rested by taking 3-4 calm breaths. The cycle was repeated 10 times. The individual did this session 4 times a day. | Other | Study group |
| Physical activity counselingIndividuals were given weekly group phone calls and meetings. Individuals were gradually accustomed to regular walking to increase their daily step count. In the first week, individuals were asked to walk a total of 30-45 minutes per day, at least 4-5 days per week, and to increase the number of steps measured at the beginning by approximately 1000-2000 steps per day to reach at least 6500 steps. In the second week, the expected goal was at least 7500 steps. In the third and fourth weeks, they were asked to reach at least 10000 steps. | Other | Study group |
Primary outcome
Daily step counts
Time frame: Baseline, at the end of everyday during 4-week and at 4 weeks after baseline evaluation
Daily average step counts were recorded via a pedometer.
6 secondary outcomes
Anxiety score
Time frame: Baseline and at 4 weeks after baseline evaluation
Depression score
Time frame: Baseline and at 4 weeks after baseline evaluation
Dyspnea score
Time frame: Baseline and at 4 weeks after baseline evaluation
Pain score
Time frame: Baseline and at 4 weeks after baseline evaluation
Fatigue score
Time frame: Baseline and at 4 weeks after baseline evaluation
Quality of life score
Time frame: Baseline and at 4 weeks after baseline evaluation
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 4 Jun 2025.
- Background: PubMed 32541352Wang TJ, Chau B, Lui M, Lam GT, Lin N, Humbert S. Physical Medicine and Rehabilitation and Pulmonary Rehabilitation for COVID-19. Am J Phys Med Rehabil. 2020 Sep;99(9):769-774. doi: 10.1097/PHM.0000000000001505.
- Background: PubMed 33163638Amini H, Isanejad A, Chamani N, Movahedi-Fard F, Salimi F, Moezi M, Habibi S. Physical activity during COVID-19 pandemic in the Iranian population: A brief report. Heliyon. 2020 Nov;6(11):e05411. doi: 10.1016/j.heliyon.2020.e05411. Epub 2020 Nov 2.
- 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.
GÜLŞAH BARĞI, Assoc. Dr. study director
Izmir Democracy University
SENA UYGUNLAR principal investigator
Izmir Democracy University
GÜLCAN POLAT principal investigator
Izmir Democracy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic expansion exercises and Physical activity counseling in people with COVID-19, run by Gulsah Bargi 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 4 inclusion and 6 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 4 Jun 2025. 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?
Daily step counts (time frame: Baseline, at the end of everyday during 4-week and at 4 weeks after baseline evaluation). 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 NCT07000331, which also lists 2 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 4 Jun 2025.