Comparison the Effects of Inspiratory Muscle Training and Aerobic Exercise Training in Patients With Post COVID-19

NCT05381779 | Unknown

• 1 other identifier: Gazi University4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 inflammation, mechanical ventilation, sedation and prolonged bed rest in hospital and intensive care patients cause decreased exercise capacity.

Conditions

COVID-19; Aerobic Exercise; Inspiratory Muscle Training; Physical Activity; Oxygen Consumption

Outcome Measures

Primary Outcomes (1)

• 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.

  First Day

Secondary Outcomes (9)

• Muscle Oxygenation

  First and second day

• Physical activity level

  Second day

• Functional exercise capacity

  Second day

• Respiratory muscle strength

  Second day

• Peripheral muscle strength

  Second day

Study Arms (3)

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.

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.

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.

Other: Control Group

Interventions

Inspiratory Muscle Training Group OTHER

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.

Inspiratory Muscle Training Group

High Intensity Interval Training Group OTHER

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.

High Intensity Interval Training Group

Control Group OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• 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.

  PMID: 33735374 RESULT

• 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.

  PMID: 33787632 RESULT

• 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.

  PMID: 33574080 RESULT

• 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.

  PMID: 32644129 RESULT

• 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.

  PMID: 32257221 RESULT

• 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.

  PMID: 31964186 RESULT

• 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.

  PMID: 26715771 RESULT

MeSH Terms

Conditions

COVID-19; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Başak KAVALCI KOL, Pt. MSc.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Ece BAYTOK, Pt. MSc.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Nilgün YILMAZ DEMİRCİ, Assoc. Prof.

  Gazi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meral BOŞNAK GÜÇLÜ, Prof.Dr.

CONTACT

+903122162647; meralbosnak@gazi.edu.tr

Başak KAVALCI KOL, Pt. MSc.

CONTACT

kavalcibasak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Investigator, Outcomes Assessor)Triple-blind study; the patients will not be informed about their groups (training group or the control group) and they will be evaluated and trained at different places and times. Evaluations and interventions will be performed different physiotherapist. In addition, before statistical analysis patients' groups will be coded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 19, 2022
• Study Start: June 5, 2022
• Primary Completion: June 5, 2024
• Study Completion: August 5, 2024
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)