Effects of Inspiratory Muscle Training in Patients With Post COVID-19

COVID-19 Clinical Trial

Official title:

Effects of Inspiratory Muscle Training on Oxygen Consumption Muscle Oxygenation and Physical Activity Level in Patients With Post-COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05231395
• Other study ID #: Gazi University-
• Status: Completed
• Phase: N/A
• Start date: February 25, 2022
• Est. completion date: May 20, 2024

Study information

• Verified date: May 2024
• Source: Gazi University
• Contact: n/a
• 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. Inspiratory muscle training may be an effective treatment modality in the treatment of dyspnea in patients with dyspnea after COVID-19. The effects of inspiratory muscle training have been investigated in different lung diseases. In these studies, inspiratory muscle training increased respiratory muscle strength and endurance, exercise capacity, and quality of life, and decreased fatigue and dyspnea.

The aim of this study is to investigate the effects of inspiratory muscle training on oxygen consumption, muscle oxygenation, physical activity level, respiratory muscle strength and endurance, peripheral muscle strength, functional exercise capacity, dyspnea, fatigue and quality of life 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: Completed
• Enrollment: 40
• Est. completion date: May 20, 2024
• Est. primary completion date: May 15, 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

• COVID-19
• 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.
• Control Group
Control group will be given breathing exercises 120 times/day, 7days/week, for 8 weeks as home program. 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 (4)

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. — 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: 10.1183/13993003.04015-2020. Print 2021 Sep. — 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 Hospitalization: A Pilot Study. Phys Ther. 2021 Jun 1;101(6):pzab099. doi: 10.1093/ptj/pzab099. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen Consumption	Cardiopulmonary Exercises Test	First Day
Secondary	Respiratory Muscle Strength	Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength were measured using a portable mouth pressure measuring device according to American Thoracic Society and European Respiratory Society criteria.	Second day
Secondary	Respiratory Muscle Endurance	Incremental threshold loading test	Second day
Secondary	Peripheral Muscle Strength	Hand held dynamometer	Second day
Secondary	Functional exercise capacity	6 minute walking test	Second day
Secondary	Fatigue Severity	Fatigue Severity Scale (Turkish version) - Fatigue Severity Scale (FSS) is a self-reported questionnaire. FSS evaluates patient's fatigue severity. This questionnaire includes 9 items and score range for each item from 1 to 7 point (7-point Likert scale). Fatigue Severity Scale score is calculates by deriving an arithmetic mean. Cut-scores of over 4 are indicative of significant fatigue (higher scores show more severe fatigue).	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
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 Time
Secondary	Muscle oxygenation	Moxy® monitor	First and second day
Secondary	Physical Activity Level	Multi sensor activity monitor	Second Day