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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05381779
• Other study ID #: Gazi University4
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2022
• Est. completion date: August 5, 2024

Study information

• Verified date: July 2023
• Source: Gazi University
• Contact: Meral BOSNAK GÜÇLÜ, Prof.Dr.
• Phone: +903122162647
• Email: meralbosnak[@]gazi.edu.tr
• Is FDA regulated: No
• Study type: Interventional

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 5, 2024
• Est. primary completion date: June 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Aerobic Exercise
• COVID-19
• Inspiratory Muscle Training
• Oxygen Consumption
• Physical Activity
• Respiratory Aspiration

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View Citation

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: 10.1183/139930 — View Citation

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. — View Citation

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 H — View Citation

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 preserv — View Citation

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 — View Citation

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 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	First and second day
Secondary	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.	Second day
Secondary	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.	Second day
Secondary	Respiratory muscle strength	Respiratory muscle strength will be assessed with mouth pressure device. Maximal inspiratory and expiratory pressure will be measured during the test.	Second day
Secondary	Peripheral muscle strength	Quadriceps femoris and shoulder abduction muscle strength will be measured by using hand-held dynamometer.	Second day
Secondary	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.	Second day
Secondary	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.	First day
Secondary	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).	First day
Secondary	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).	First Day