Effect of Resistive Inspiratory Muscle Training Optimizing Lung Function in Spinal Cord Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Dhaka
About this trial
The goal of this clinical trial is to evaluate the effectiveness of resistive inspiratory muscle training (RIMT) in optimizing lung function in individuals with spinal cord injury (SCI). It will also learn about the safety and impact of RIMT on health-related quality of life in this population. The main questions it aims to answer are:
Does RIMT improve respiratory function in individuals with SCI? What impact does RIMT have on the health-related quality of life of participants? What are the perceived exertion or dyspnoea levels in participants undergoing RIMT? Researchers will compare RIMT to conventional respiratory physiotherapy to see if RIMT works to enhance lung function and improve overall respiratory outcomes in individuals with SCI.
Participants will:
Perform resistive inspiratory muscle training along with conventional respiratory physiotherapy 5 days a week for 4 weeks.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
People with Traumatic Cervical Cord Injury
Impaired respiratory function
Disqualifiers
Participants who have Progressive diseases, Head injury, A psychiatric condition , Medical instability, Ventilator dependency, and Presence of tracheostomy
Trial design
Design model
Parallel
Treatments tested in this trial
Usual Care
Other interventionParticipants in the control group will recieve usual care.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Resistive Inspiratory Muscle TrainingExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Lung function
The spirometer is a medical device used to measure lung function by assessing the volume of air inhaled and exhaled. During a spirometry test, the patient breathes into a mouthpiece connected to the spirometer, which records the amount and rate of air breathed in and out. Key measurements include forced vital capacity (FVC) and forced expiratory volume in one second (FEV1).
Time frame
at baseline and after 4 week2
Expiratory flow rate during forced expiration
The peak flow meter is a device used to measure how well air moves out of the lungs. It helps assess the peak expiratory flow rate (PEFR), which is the fastest rate at which a person can blow air out of their lungs after taking a deep breath.
Time frame
at baseline and after 4 week3
Health-Related Quality of Life (HRQoL)
The SF-12 is a validated and reliable health survey that measures health-related quality of life. It comprises 12 questions covering eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Responses are used to calculate summary scores for physical and mental health.
Time frame
at baseline and after 4 week4
Perceived exertion and dyspnoea
The Modified Borg Scale is a validated tool for measuring perceived exertion during physical activity, ranging from 0 (no exertion) to 10 (maximal exertion). It allows individuals to rate their effort intensity, serving as a subjective measure of physical strain.
Time frame
at baseline and after 4 weekLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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