Effect of Functional Inspiratory Muscle Training in Patients with Multiple Sclerosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSelcuk University
About this trial
This study aims to investigate the effects of functional inspiratory muscle training, basic inspiratory muscle training and physical activity in addition to respiratory exercises on respiratory muscle strength, respiratory function, cognition, walking, balance, functional exercise capacity, physical activity, quality of life and core muscles in volunteer Multiple Sclerosis (MS) patients. This study is planned as a prospective, randomized and experimental study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with Relapsing Remitting Type Multiple Sclerosis (RRMS),
EDSS (Expanded Disability Status Scale in MS: EDSS) score ranging from 1-5,
Able to communicate (speak, understand, read and understand Turkish),
Individuals who have not had an attack in the last three months,
Disqualifiers
Those with neurological diseases other than MS,
Those who have functional exercise restrictions,
Those with chronic cardiac or pulmonary diseases such as chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease and heart failure that may affect respiratory muscle strength and respiratory functions,
Individuals who have had pneumonia due to viral or bacterial infection in the last six months or COVID-19 positive individuals proven by PCR-RT,
Trial design
Design model
Parallel
Treatments tested in this trial
Functional Inspiratory Muscle Training
Other interventionThe functional inspiratory muscle training group will perform basic inspiratory muscle training in the first four weeks of the study and the following exercises with the Powerbreath device in muscle training in the following four weeks: 1. Diaphragmatic breathing exercises 2. Warm-up exercises 3. Trunk strength and lumbopelvic stability exercises 4. Dynamic trunk exercises 5. Postural control exercises 6. Cool-down exercises
Basic Inspiratory Muscle Training
Other interventionThe basic inspiratory muscle training group will do muscle training with the POWERbreathe device for eight weeks.
Treatment groups
63 Participants
are divided into 3 treatment groupsGroup A: Functional Inspiratory Muscle Training GroupExperimental treatment 1 intervention
Group B: Basic Inspiratory Muscle Training GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Inspiratory Respiratory Muscle Strength
Participants' respiratory muscle strength will be measured with a portable device (Micro Medical Micro RPM, UK) that can measure intraoral pressure electronically, which is a non-invasive method, and the results will be recorded as maximal inspiratory pressure (MIP). The participant's nose will be closed with a valve while they are maximally expiratory in a sitting position, and a maximal inspiration will be requested for 1 - 3 seconds to complete the MIP measurement and the measurements will be recorded. The highest of the three best results, with no more than 10% difference between them, among at least five measurements will be recorded as the final data.
Time frame
8 weeks2
Expiratory Respiratory Muscle Strength
Participants' respiratory muscle strength will be measured with a portable device (Micro Medical Micro RPM, UK) that can electronically measure intraoral pressure, which is a non-invasive method, and the results will be recorded as maximal expiratory pressure (MEP). MEP measurement will be completed by closing the nose of the participant who is maximally inspiratory in a sitting position with a valve and asking the participant to exhale maximally for 1-3 seconds, and the measurements will be recorded. The highest of the three best results, with no more than 10% difference between them, among at least five measurements will be recorded as the final data.
Time frame
8 weeks3
Respiratory Function (FEV₁)
Respiratory functions will be assessed with a portable spirometer with the patient in a sitting position according to the criteria set by the American Thoracic Society and the European Respiratory Society. Spirometry measures multiple parameters during a single test. Participants will be asked to take a single forced breath during normal breathing and then exhale a single forced breath, measuring the forced expiratory volume (FEV₁) in the first second of the lung function test.
Time frame
8 weeks4
Respiratory Function (FVC)
Participants will be asked to take a single forced breath during normal breathing and then exhale a single forced breath, measuring the forced vital capacity (FVC) of the lung function test.
Time frame
8 weeksSponsors and contacts
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Source ClinicalTrials.gov
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