COVID-19NCT05381779
Comparison the Effects of Inspiratory Muscle Training and Aerobic Exercise Training in Patients With Post COVID-19
A study testing Inspiratory Muscle Training Group and High Intensity Interval Training Group in people with COVID-19 and Aerobic Exercise, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Coronavirus-2019 (COVID-19) is a new virus that emerged in December 2019 and spread quickly all over the world. Problems such as hypoxia, dyspnea, increased fatigue, decreased exercise capacity and respiratory muscle strength occur in COVID-19 patients.In addition, abnormalities in skeletal muscles due to systemic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19, Aerobic Exercise, Inspiratory Muscle Training
- What is being tested?
- Inspiratory Muscle Training Group and High Intensity Interval Training Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2022to 5 Aug 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18-75
- Diagnosed with COVID-19
- COVID-19 Polymerase Chain Reaction (PCR) test result negative
- Volunteer to participate in the study
Who cannot join
- Body mass index >35 kg/m2
- Acute pulmonary exacerbation, acute upper or lower respiratory tract infection
- Aortic stenosis, complex arrhythmia, aortic aneurysm
- Serious neurological, neuromuscular, orthopedic, other systemic diseases or other diseases affecting physical functions
- Cognitive impairment that causes difficulty in understanding and following exercise test instructions
- Participated in a planned exercise program in the last three months
Show all 9Show fewer
- Bulla formation in the lung
- Uncontrolled hypertension and/or diabetes mellitus, heart failure and cardiovascular disease
- Contraindication for exercise testing and/or exercise training according to the American College of Sports Medicine
Trial locations and contacts
1 site in 1 country.
Başak KAVALCI KOL, Pt. MSc. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic
Ankara, 06560
Meral Boşnak Güçlü, Prof. Dr., +903122162647, meralbosnak@gazi.edu.tr
Başak Kavalcı Kol, Pt. MSc
About this study
Official title: Comparison the Effects of Inspiratory Muscle Training and High Intensity Interval Aerobic Exercise Training in Patients With Post COVID-19
Coronavirus-2019 (COVID-19) is a new virus that emerged in December 2019 and spread quickly all over the world. Problems such as hypoxia, dyspnea, increased fatigue, decreased exercise capacity and respiratory muscle strength occur in COVID-19 patients.In addition, abnormalities in skeletal muscles due to systemic inflammation, mechanical ventilation, sedation and prolonged bed rest in hospital and intensive care patients cause decreased exercise capacity.
Read the detailed description
Dyspnea is one of the most common long-term symptoms in COVID-19 patients. It has been determined that dyspnea that persists three and six months after hospital discharge is associated with peak oxygen consumption in hospitalized and discharged COVID-19 patients, while peak oxygen consumption decreases in patients with dyspnea.The effects of inspiratory muscle training have been investigated in different lung diseases. In these studies, it was reported that inspiratory muscle training increased respiratory muscle strength and endurance, exercise capacity and quality of life, and decreased fatigue and dyspnea. In addition, it has been found that high-intensity interval aerobic exercise training increases exercise capacity in patients with lung disease and heart failure.In heart failure patients, it was found that high-intensity interval aerobic exercise training increased peak oxygen consumption more than moderate-intensity continuous aerobic exercise training.Patients need exercise training because symptoms such as lung involvement, decreased exercise capacity, dyspnea and fatigue continue after the disease in patients who have had COVID-19.
The aim of this study is to comparison of the effects of inspiratory muscle training and high intensity interval aerobic exercise training in patients with COVID-19.
Primary outcome measurement will be oxygen consumption (cardiopulmonary exercise test).
Secondary outcome will be muscle oxygenation (Moxy device), physical activity level (multi sensor activity device), pulmonary function (spirometer), functional exercise capacity (six-minute walk test), respiratory (mouth pressure device) and peripheral muscle (hand-held dynamometer) strength, inspiratory muscle endurance (incremental threshold loading test), functional status (Post-COVID-19 Functional Status Scale), dyspnea (London Chest Daily Living Activity Scale), fatigue (Fatigue Severity Scale) and quality of life (Saint George Respiratory Questionnaire).
- Conditions
- COVID-19, Aerobic Exercise, Inspiratory Muscle Training, Physical Activity, Oxygen Consumption
- Being tested
- Inspiratory Muscle Training Group, High Intensity Interval Training Group, Control Group
- 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.
Inspiratory Muscle Training GroupOther
Patients in the training group will receive inspiratory muscle training with the PowerBreathe® (inspiratory muscle training device) at 50% of the maximal inspiratory pressure.
Patients in the training group inspiratory muscle training will be given 2 sets of 15 minutes a day for a total of 30 minutes/per day or a single session for 30 minutes/week, 7 days/week for a total of 8 weeks.
Patients in the training group will be given respiratory muscle strength training with a home program 6 days a week under the supervision of a physiotherapist 1 day a week.
High Intensity Interval Training GroupOther
High-intensity interval aerobic exercise training will be given to training group on treadmill 3 days in a week and 15-45 minutes in a day for 8 weeks with the assistance of a physiotherapist.
The training workload of the active phase of high-intensity interval aerobic exercise training will be applied at 80-100% of peak oxygen consumption or 85-95% of peak heart rate or according to Borg scale dyspnea/fatigue 15-18 points.
The training workload of the active recovery phase of high-intensity interval aerobic exercise training will be applied at 50-60% of peak oxygen consumption or 60-75% of peak heart rate or according to Borg scale dyspnea/fatigue 11-13 points.
Control GroupOther
Breathing exercises will be given to the control group 120 times in a day and 7 days in a week for 8 weeks as a home program. The control group will be followed-up by telephone once a week.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training Group | Experimental | Patients in the training group will be performed inspiratory muscle training with the PowerBreathe® (inspiratory muscle training device) device at 50% of the maximal inspiratory pressure. Receives: Other: Inspiratory Muscle Training Group |
| High Intensity Interval Training Group | Experimental | Training group will receive high-intensity interval aerobic exercise training on treadmill accompanied by physiotherapist for 8 weeks. Receives: Other: High Intensity Interval Training Group |
| Control Group | Sham comparator | Breathing exercises will be given to control group as a home program for 8 weeks. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen consumption
Maximal exercise capacity will be assessed with symptom limited cardiopulmonary exercise test on a treadmill at a progressively increasing speed and grade. Oxygen consumption will be measured during the test.
Measured: First Day
Secondary outcomes (9)
Muscle Oxygenation
Muscle oxygenation will be measured with 'Moxy' muscle oxygenation device during cardiopulmonary exercise test and six-minute walk test. Measurements will be done over quadriceps femoris, locally. Local muscle oxygen saturation and total hemoglobin amount will be assessed during the both tests.
Measured: First and second day
Physical activity level
Physical activity level will be evaluated with multi sensor activity device. Patients will be asked to wear the device for five consecutive days on weekdays.
Measured: Second day
Functional exercise capacity
Six-minute walk test will be used to evaluate functional exercise capacity. The test will be done according to American Thoracic Society and European Respiratory Society criteria.
Measured: Second day
Respiratory muscle strength
Respiratory muscle strength will be assessed with mouth pressure device. Maximal inspiratory and expiratory pressure will be measured during the test.
Measured: Second day
Peripheral muscle strength
Quadriceps femoris and shoulder abduction muscle strength will be measured by using hand-held dynamometer.
Measured: Second day
Inspiratory muscle endurance
Inspiratory muscle endurance will be measured incremental threshold loading test, in which patients started an initial load of 30% of maximal inspiratory pressure and test load will be increased with among 10% of maximal inspiratory pressure every 2 minutes.
Measured: Second day
Functional status
Functional status of patients after COVID-19 will be evaluated with Post COVID-19 Functional Status Scale (PCFS), which was developed specifically for COVID patients. Limitation and improvement in the functional status of patients after COVID could be assessed with this scale. Functional status were graded from 0 (no functional limitations) to 4 (severe functional limitations) in the scale.
Measured: First day
Dyspnea
London Chest Activity of Daily Living scale (LCADL): LCADL evaluates the limitation to perform activities of daily living by dyspnea and looks at four domains: selfcare, domestic, physical and leisure. It is composed of 15 items, which are scored by the patient as follows: 0 (I do not perform this activity because I never had to do it or it is irrelevant), 1 (I do not feel any breathless when performing this activity), 2 (I feel moderate breathless when performing this activity), 3 (I feel a lot of breathless in doing this activity), 4 (I cannot perform this activity due to breathless and I have no one who can do the activity for me) or 5 (I cannot perform this activity anymore and I need someone to do it for me or help me because of breathless).
Measured: First day
Respiratory Associated Quality of Life (respiratory)
St. George Respiratory Questionnaire (Turkish version) (respiratory) - St. George Respiratory Questionnaire (SGRQ) is a self-reported questionnaire. SGRQ evaluates patients' respiratory disease associated quality of life. This questionnaire includes 2 part (part one is about symptoms (one subsection) and part two is about activity (seven subsection)) and 50 items. Some items scored as Likert scale and others scored as dichotomous (true/false).
Measured: First Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start5 Jun 2022
- Primary completion5 Jun 2024 (estimated)
- Study completion5 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Başak KAVALCI KOL, Pt. MSc., Principal investigator, Gazi UniversityEce BAYTOK, Pt. MSc., Principal investigator, Gazi UniversityNilgün YILMAZ DEMİRCİ, Assoc. Prof., Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381779
- Sponsor's protocol ID
- Gazi University4
- Status last verified
- Jul 2023
- First submitted
- 17 May 2022
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Debeaumont D, Boujibar F, Ferrand-Devouge E, Artaud-Macari E, Tamion F, Gravier FE, Smondack P, Cuvelier A, Muir JF, Alexandre K, Bonnevie T. Cardiopulmonary Exercise Testing to Assess Persistent Symptoms at 6 Months in People With COVID-19 Who Survived Hospitalization: A Pilot Study. Phys Ther. 2021 Jun 1;101(6):pzab099. doi: 10.1093/ptj/pzab099.
PubMed 33735374Abodonya AM, Abdelbasset WK, Awad EA, Elalfy IE, Salem HA, Elsayed SH. Inspiratory muscle training for recovered COVID-19 patients after weaning from mechanical ventilation: A pilot control clinical study. Medicine (Baltimore). 2021 Apr 2;100(13):e25339. doi: 10.1097/MD.0000000000025339.
PubMed 33787632Anastasio F, Barbuto S, Scarnecchia E, Cosma P, Fugagnoli A, Rossi G, Parravicini M, Parravicini P. Medium-term impact of COVID-19 on pulmonary function, functional capacity and quality of life. Eur Respir J. 2021 Sep 16;58(3):2004015. doi: 10.1183/13993003.04015-2020. Print 2021 Sep.
PubMed 33574080Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
PubMed 32644129Sawyer A, Cavalheri V, Hill K. Effects of high intensity interval training on exercise capacity in people with chronic pulmonary conditions: a narrative review. BMC Sports Sci Med Rehabil. 2020 Mar 30;12:22. doi: 10.1186/s13102-020-00167-y. eCollection 2020.
PubMed 32257221Donelli da Silveira A, Beust de Lima J, da Silva Piardi D, Dos Santos Macedo D, Zanini M, Nery R, Laukkanen JA, Stein R. High-intensity interval training is effective and superior to moderate continuous training in patients with heart failure with preserved ejection fraction: A randomized clinical trial. Eur J Prev Cardiol. 2020 Nov;27(16):1733-1743. doi: 10.1177/2047487319901206. Epub 2020 Jan 21.
PubMed 31964186Karadalli MN, Bosnak-Guclu M, Camcioglu B, Kokturk N, Turktas H. Effects of Inspiratory Muscle Training in Subjects With Sarcoidosis: A Randomized Controlled Clinical Trial. Respir Care. 2016 Apr;61(4):483-94. doi: 10.4187/respcare.04312. Epub 2015 Dec 29.
PubMed 26715771
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Effects of Inspiratory Muscle Training and High Intensity Interval Aerobic Exercise Training in Patients With Post COVID-19
- ClinicalTrials.gov ID
- NCT05381779
- Acronym / sponsor ID
- Gazi University4
- Conditions
- COVID-19, Aerobic Exercise, Inspiratory Muscle Training, Physical Activity, Oxygen Consumption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 5 Jun 2024 (estimated)
- Study completion
- 5 Aug 2024 (estimated)
- First posted
- 19 May 2022 (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.
Coronavirus-2019 (COVID-19) is a new virus that emerged in December 2019 and spread quickly all over the world. Problems such as hypoxia, dyspnea, increased fatigue, decreased exercise capacity and respiratory muscle strength occur in COVID-19 patients.In addition, abnormalities in skeletal muscles due to systemic inflammation, mechanical ventilation, sedation and prolonged bed rest in hospital and intensive care patients cause decreased exercise capacity.
Detailed description
Dyspnea is one of the most common long-term symptoms in COVID-19 patients. It has been determined that dyspnea that persists three and six months after hospital discharge is associated with peak oxygen consumption in hospitalized and discharged COVID-19 patients, while peak oxygen consumption decreases in patients with dyspnea.The effects of inspiratory muscle training have been investigated in different lung diseases. In these studies, it was reported that inspiratory muscle training increased respiratory muscle strength and endurance, exercise capacity and quality of life, and decreased fatigue and dyspnea. In addition, it has been found that high-intensity interval aerobic exercise training increases exercise capacity in patients with lung disease and heart failure.In heart failure patients, it was found that high-intensity interval aerobic exercise training increased peak oxygen consumption more than moderate-intensity continuous aerobic exercise training.Patients need exercise training because symptoms such as lung involvement, decreased exercise capacity, dyspnea and fatigue continue after the disease in patients who have had COVID-19.
The aim of this study is to comparison of the effects of inspiratory muscle training and high intensity interval aerobic exercise training in patients with COVID-19.
Primary outcome measurement will be oxygen consumption (cardiopulmonary exercise test).
Secondary outcome will be muscle oxygenation (Moxy device), physical activity level (multi sensor activity device), pulmonary function (spirometer), functional exercise capacity (six-minute walk test), respiratory (mouth pressure device) and peripheral muscle (hand-held dynamometer) strength, inspiratory muscle endurance (incremental threshold loading test), functional status (Post-COVID-19 Functional Status Scale), dyspnea (London Chest Daily Living Activity Scale), fatigue (Fatigue Severity Scale) and quality of life (Saint George Respiratory Questionnaire).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training Group | Experimental | Other: Inspiratory Muscle Training GroupPatients in the training group will be performed inspiratory muscle training with the PowerBreathe® (inspiratory muscle training device) device at 50% of the maximal inspiratory pressure. |
| High Intensity Interval Training Group | Experimental | Other: High Intensity Interval Training GroupTraining group will receive high-intensity interval aerobic exercise training on treadmill accompanied by physiotherapist for 8 weeks. |
| Control Group | Sham comparator | Other: Control GroupBreathing exercises will be given to control group as a home program for 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between the ages of 18-75
- Diagnosed with COVID-19
- COVID-19 Polymerase Chain Reaction (PCR) test result negative
- Volunteer to participate in the study
Key exclusion criteria (9 listed)
- Body mass index >35 kg/m2
- Acute pulmonary exacerbation, acute upper or lower respiratory tract infection
- Aortic stenosis, complex arrhythmia, aortic aneurysm
- Serious neurological, neuromuscular, orthopedic, other systemic diseases or other diseases affecting physical functions
- Cognitive impairment that causes difficulty in understanding and following exercise test instructions
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 |
|---|---|---|
| Inspiratory Muscle Training GroupPatients in the training group will receive inspiratory muscle training with the PowerBreathe® (inspiratory muscle training device) at 50% of the maximal inspiratory pressure. Patients in the training group inspiratory muscle training will be given 2 sets of 15 minutes a day for a total of 30 minutes/per day or a single session for 30 minutes/week, 7 days/week for a total of 8 weeks. Patients in the training group will be given respiratory muscle strength training with a home program 6 days a week under the supervision of a physiotherapist 1 day a week. | Other | Inspiratory Muscle Training Group |
| High Intensity Interval Training GroupHigh-intensity interval aerobic exercise training will be given to training group on treadmill 3 days in a week and 15-45 minutes in a day for 8 weeks with the assistance of a physiotherapist. The training workload of the active phase of high-intensity interval aerobic exercise training will be applied at 80-100% of peak oxygen consumption or 85-95% of peak heart rate or according to Borg scale dyspnea/fatigue 15-18 points. The training workload of the active recovery phase of high-intensity interval aerobic exercise training will be applied at 50-60% of peak oxygen consumption or 60-75% of peak heart rate or according to Borg scale dyspnea/fatigue 11-13 points. | Other | High Intensity Interval Training Group |
| Control GroupBreathing exercises will be given to the control group 120 times in a day and 7 days in a week for 8 weeks as a home program. The control group will be followed-up by telephone once a week. | Other | Control Group |
Primary outcome
Oxygen consumption
Time frame: First Day
Maximal exercise capacity will be assessed with symptom limited cardiopulmonary exercise test on a treadmill at a progressively increasing speed and grade. Oxygen consumption will be measured during the test.
9 secondary outcomes
Muscle Oxygenation
Time frame: First and second day
Physical activity level
Time frame: Second day
Functional exercise capacity
Time frame: Second day
Respiratory muscle strength
Time frame: Second day
Peripheral muscle strength
Time frame: Second day
Inspiratory muscle endurance
Time frame: Second day
Functional status
Time frame: First day
Dyspnea
Time frame: First day
Respiratory Associated Quality of Life (respiratory)
Time frame: First Day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Results publication: PubMed 33735374Debeaumont D, Boujibar F, Ferrand-Devouge E, Artaud-Macari E, Tamion F, Gravier FE, Smondack P, Cuvelier A, Muir JF, Alexandre K, Bonnevie T. Cardiopulmonary Exercise Testing to Assess Persistent Symptoms at 6 Months in People With COVID-19 Who Survived Hospitalization: A Pilot Study. Phys Ther. 2021 Jun 1;101(6):pzab099. doi: 10.1093/ptj/pzab099.
- Results publication: PubMed 33787632Abodonya AM, Abdelbasset WK, Awad EA, Elalfy IE, Salem HA, Elsayed SH. Inspiratory muscle training for recovered COVID-19 patients after weaning from mechanical ventilation: A pilot control clinical study. Medicine (Baltimore). 2021 Apr 2;100(13):e25339. doi: 10.1097/MD.0000000000025339.
- Results publication: PubMed 33574080Anastasio F, Barbuto S, Scarnecchia E, Cosma P, Fugagnoli A, Rossi G, Parravicini M, Parravicini P. Medium-term impact of COVID-19 on pulmonary function, functional capacity and quality of life. Eur Respir J. 2021 Sep 16;58(3):2004015. doi: 10.1183/13993003.04015-2020. Print 2021 Sep.
- Results publication: PubMed 32644129Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
- Results publication: PubMed 32257221Sawyer A, Cavalheri V, Hill K. Effects of high intensity interval training on exercise capacity in people with chronic pulmonary conditions: a narrative review. BMC Sports Sci Med Rehabil. 2020 Mar 30;12:22. doi: 10.1186/s13102-020-00167-y. eCollection 2020.
- Results publication: PubMed 31964186Donelli da Silveira A, Beust de Lima J, da Silva Piardi D, Dos Santos Macedo D, Zanini M, Nery R, Laukkanen JA, Stein R. High-intensity interval training is effective and superior to moderate continuous training in patients with heart failure with preserved ejection fraction: A randomized clinical trial. Eur J Prev Cardiol. 2020 Nov;27(16):1733-1743. doi: 10.1177/2047487319901206. Epub 2020 Jan 21.
- Results publication: PubMed 26715771Karadalli MN, Bosnak-Guclu M, Camcioglu B, Kokturk N, Turktas H. Effects of Inspiratory Muscle Training in Subjects With Sarcoidosis: A Randomized Controlled Clinical Trial. Respir Care. 2016 Apr;61(4):483-94. doi: 10.4187/respcare.04312. Epub 2015 Dec 29.
- 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.
Başak KAVALCI KOL, Pt. MSc. contact
Başak KAVALCI KOL, Pt. MSc. principal investigator
Gazi University
Ece BAYTOK, Pt. MSc. principal investigator
Gazi University
Nilgün YILMAZ DEMİRCİ, Assoc. Prof. principal investigator
Gazi 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 Inspiratory Muscle Training Group and High Intensity Interval Training Group in people with COVID-19 and Aerobic Exercise, run by Gazi 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 4 inclusion and 9 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 25 Jul 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. Some participants in this study may receive a placebo. 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?
Contact Meral BOŞNAK GÜÇLÜ, Prof.Dr. (+903122162647, meralbosnak@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen consumption (time frame: First Day). 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 NCT05381779, which also lists 7 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 25 Jul 2023.