Effectiveness of Functional Respiratory Muscle Training in Post-COVID-19 Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHacettepe University
About this trial
This study aims to investigate the effects of core stabilization exercises and functional inspiratory muscle training (IMT) on various physiological and psychological parameters in individuals with post-COVID-19 syndrome. Participants diagnosed with post-COVID-19 syndrome will be randomly assigned to two groups using stratified computer-assisted randomization. One group will undergo an 8-week core stabilization training, while the other will receive combined core stabilization and IMT training. Exercise training will be conducted three times a week, with each session lasting 50 minutes.
Comprehensive pre- and post-intervention assessments will be conducted, including exercise capacity, respiratory and peripheral muscle strength, trunk endurance, balance, anxiety, depression, and fatigue levels. The primary outcome measures are respiratory muscle strength and trunk endurance.
Participants must be aged 18-65 years, have at least a primary education level, speak Turkish, and be classified as level 2-3 on the Post-COVID-19 Functional Status Scale (PCFS). Eligible participants will be referred by the Internal Medicine Department at Hacettepe University.
The study will utilize various assessment tools, including maximal inspiratory/expiratory pressure (MIP/MEP) tests, Functional Movement Screen (FMS), plank and Sorenson endurance tests, the Timed Up and Go Test for balance, handgrip and knee extension strength tests, body composition analysis, and the SF-36 quality of life questionnaire.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with Post-COVID-19 Syndrome.
Literate and able to understand study procedures.
Aged between 18 and 65 years.
Willing to voluntarily participate in the study.
Disqualifiers
History of recent myocardial infarction or pulmonary embolism.
Presence of uncontrolled chronic diseases.
Any orthopedic or neurological disorders that limit mobility.
Neurological impairments (e.g., cerebrovascular disease) or psychiatric disorders that impair cooperation or compliance with exercise testing.
Trial design
Design model
Parallel
Treatments tested in this trial
Core Stabilization
Other intervention12-week supervised core stabilization training, 3 sessions per week, 45 minutes per session.
Functional Inspiratory Muscle Training (IMT)
Other interventionIMT using a portable inspiratory muscle training device at 60% MIP, progressively increased over 12 weeks.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Core Stabilization GroupActive comparator 1 intervention
Group B: Functional IMT GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Respiratory muscle strength
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) with mouth-pressure device
Time frame
Baseline and after 12 weeks of intervention.2
Plank Endurance Test
Plank Test: Plank time is a common test to evaluate core stability. The patient is given a plank position and the maximum endurance time they can hold this position is measured.
Time frame
Baseline and after 12 weeks of intervention.3
Sorenson Endurance Test
Sorenson Test (Extensor Endurance Test): In this test, the person lies horizontally on the end of a table and is asked to keep their body in a fixed position outside the table. The endurance time in this position is evaluated to measure core stability.
Time frame
Baseline and after 12 weeks of intervention.4
Side Bridge Endurance Test
Side Bridge Test: It is an endurance test based on time in the side plank position. The difference between the times on the right and left sides can provide information about core stabilization.
Time frame
Baseline and after 12 weeks of intervention.Secondary outcomes
1
Health Status
The Short-Form-36 is a quality of life questionnaire consisting of 11 sections and 36 questions in total. The minimum and maximum scores range between 0 and 100. Higher score indicate a more favorable health status.
Time frame
Baseline and after 12 weeks of intervention.2
Fatigue Perception
Fatigue Severity Scale consists of 9 questions that indicate severity of fatigue in daily life. The total score 4 and more indicate the presence of severe fatigue and ranges between 0-7.
Time frame
Baseline and after 12 weeks of intervention.3
Dynamic respiratory muscle strength
In the dynamic method, respiratory muscle strength index (S index) and peak inspiratory flow rate (PIF) will be assessed using the portable POWERbreathe K5 device (PowerBreathe K5, HaB International Ltd, Warwickshire, England).
Time frame
Baseline and after 12 weeks of intervention.4
Exercise motivation
Patients' exercise motivation levels and attitudes will be assessed with the Exercise Motivation Attitude Questionnaire. The Exercise Motivation Attitude Scale consists of 20 items and three subscales. The total score that can be obtained from the scale ranges from 20 to 140 (minimum 20, maximum 140). The score varies depending on the number of items in the subscales. Higher scores indicate better exercise motivation
Time frame
Baseline and after 12 weeks of intervention.Sponsors and contacts
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Source ClinicalTrials.gov