Comparison the Effects of Inspiratory Muscle Training and Aerobic Exercise Training in Patients With Post COVID-19
NCT ID: NCT05381779
Last Updated: 2023-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-06-05
2024-08-05
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Evaluations and interventions will be performed different physiotherapist. In addition, before statistical analysis patients' groups will be coded.
Study Groups
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Inspiratory Muscle Training Group
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.
Inspiratory Muscle Training Group
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 Group
Training group will receive high-intensity interval aerobic exercise training on treadmill accompanied by physiotherapist for 8 weeks.
High Intensity Interval Training Group
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 Group
Breathing exercises will be given to control group as a home program for 8 weeks.
Control Group
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.
Interventions
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Inspiratory Muscle Training Group
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 Group
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 Group
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with COVID-19
* COVID-19 Polymerase Chain Reaction (PCR) test result negative
* Volunteer to participate in the study
Exclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Gazi University
OTHER
Responsible Party
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Meral Boşnak Güçlü
Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic
Principal Investigators
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Başak KAVALCI KOL, Pt. MSc.
Role: PRINCIPAL_INVESTIGATOR
Gazi University
Ece BAYTOK, Pt. MSc.
Role: PRINCIPAL_INVESTIGATOR
Gazi University
Nilgün YILMAZ DEMİRCİ, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Gazi University
Locations
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Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Abodonya 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.
Anastasio 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.
Carfi 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.
Sawyer 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.
Donelli 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.
Karadalli 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.
Other Identifiers
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Gazi University4
Identifier Type: -
Identifier Source: org_study_id
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