Comparison the Effects of Inspiratory Muscle Training and High Intensity Interval Aerobic Exercise Training in Patients With Post COVID-19
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Gazi University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Oxygen consumption
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Inspiratory Muscle Training Group
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.
Intervention: Inspiratory Muscle Training Group (Other)
High Intensity Interval Training Group
Training group will receive high-intensity interval aerobic exercise training on treadmill accompanied by physiotherapist for 8 weeks.
Intervention: High Intensity Interval Training Group (Other)
Control Group
Breathing exercises will be given to control group as a home program for 8 weeks.
Intervention: Control Group (Other)
Outcomes
Primary Outcomes
Oxygen consumption
Time Frame: First Day
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.
Secondary Outcomes
- Muscle Oxygenation(First and second day)
- Inspiratory muscle endurance(Second day)
- Physical activity level(Second day)
- Functional exercise capacity(Second day)
- Respiratory muscle strength(Second day)
- Peripheral muscle strength(Second day)
- Functional status(First day)
- Dyspnea(First day)
- Respiratory Associated Quality of Life (respiratory)(First Day)
Investigators
Meral Boşnak Güçlü
Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic
Gazi University