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NCT Number: NCT05231395

Effects of Inspiratory Muscle 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.

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Key information

Conditions

COVID-19 Behavior Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Motor Activity Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ankara, 06560, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control Group

Other

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

Primary outcomes

  1. Oxygen Consumption

    Time frame: First Day

    Cardiopulmonary Exercises Test

Secondary outcomes

  1. Respiratory Muscle Strength

    Time frame: Second day

    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.

  2. Respiratory Muscle Endurance

    Time frame: Second day

    Incremental threshold loading test

  3. Peripheral Muscle Strength

    Time frame: Second day

    Hand held dynamometer

  4. Functional exercise capacity

    Time frame: Second day

    6 minute walking test

  5. Fatigue Severity

    Time frame: First day

    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).

  6. Respiratory Associated Quality of Life (respiratory)

    Time frame: First day

    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).

  7. Dyspnea

    Time frame: First Time

    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).

  8. Muscle oxygenation

    Time frame: First and second day

    Moxy® monitor

  9. Physical Activity Level

    Time frame: Second Day

    Multi sensor activity monitor

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2022
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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