Clinical trial NCT05381779: Comparison the Effects of Inspiratory Muscle Training and Aerobic Exercise Training in Patients With Post COVID-19
Official title: Comparison the Effects of Inspiratory Muscle Training and High Intensity Interval Aerobic Exercise Training in Patients With Post COVID-19
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19
Aerobic Exercise
Inspiratory Muscle Training
Physical Activity
Oxygen Consumption
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Oxygen consumption
timeFrame: First Day
Secondary outcomes:
measure: Muscle Oxygenation
timeFrame: First and second day
measure: Physical activity level
timeFrame: Second day
measure: Functional exercise capacity
timeFrame: Second day
measure: Respiratory muscle strength
timeFrame: Second day
measure: Peripheral muscle strength
timeFrame: Second day
measure: Inspiratory muscle endurance
timeFrame: Second day
measure: Functional status
timeFrame: First day
measure: Dyspnea
timeFrame: First day
measure: Respiratory Associated Quality of Life (respiratory)
timeFrame: First Day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic
Study officials:
affiliation: Gazi University
name: Başak KAVALCI KOL, Pt. MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Ece BAYTOK, Pt. MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Nilgün YILMAZ DEMİRCİ, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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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.