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NCT Number: NCT06547606

Effect of Resistive Inspiratory Muscle Training Optimizing Lung Function in Spinal Cord Injury

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.

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Key information

About this study

Globally, over 15 million people are living with spinal cord injury (SCI), according to the World Health Organization (WHO) in 2024. SCI disrupts the normal functioning of the spinal cord, leading to significant physical and neurological impairments. One of the major challenges in SCI management is respiratory complications, which contribute significantly to morbidity and mortality. Resistive inspiratory muscle training (RIMT) has emerged as a promising intervention to enhance respiratory muscle strength and function, potentially reducing respiratory complications in SCI.

The primary objective of this clinical trial is to evaluate the effectiveness of RIMT in optimizing lung function in individuals with SCI. The study also aims to assess the safety of RIMT and its impact on the health-related quality of life of participants.

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.

The study population will consist of individuals with cervical spinal cord injury (SCI) who have impaired respiratory function and are admitted for inpatient rehabilitation. The inclusion criteria include individuals aged 18 to 65 years with cervical cord injury and impaired respiratory function. Exclusion criteria include progressive diseases, head injury, psychiatric conditions, medical instability, ventilator dependency, and the presence of a tracheostomy.

The clinical trial will be conducted at the Spinal Cord Injury Unit of the Centre for the Rehabilitation of the Paralyzed (CRP) in Savar, Dhaka. The CRP provides comprehensive rehabilitation services to patients from all over Bangladesh, ensuring that the study population reflects a broad demographic and economic spectrum.

This study is designed as a randomized controlled trial (RCT) with participants randomly allocated to either the intervention group or the control group. The intervention group will receive resistive inspiratory muscle training (RIMT) in addition to conventional respiratory physiotherapy, while the control group will receive only conventional respiratory physiotherapy.

Data collection will involve a range of tools to assess primary and secondary outcomes:

  • Incentive Spirometry: Assesses lung function.
  • Peak Flow Meter: Measures Peak Expiratory Flow (PEF), assessing expiratory flow rate during forced expiration.
  • SF-12 Health Survey: Assesses health-related quality of life (HRQoL) across various physical and mental health aspects.
  • Modified Borg Scale: Subjective assessment of perceived exertion and dyspnoea.
  • Structured Questionnaire: To gather socio-demographic indicators and additional relevant data.

Data will be analyzed using SPSS version 22. Descriptive statistics will include pie charts, bar charts, and linear line diagrams. Parametric tests such as paired t-tests and unrelated t-tests will be employed to analyze the data. Variables such as mean, mean difference, standard deviations, standard error, degree of freedom, and significance level will be calculated to demonstrate significant differences within and between the experimental and control groups.

By conducting this trial, the study aims to provide robust evidence on the potential benefits of RIMT in improving respiratory function and overall quality of life in individuals with SCI.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People with Traumatic Cervical Cord Injury
  • Impaired respiratory function

Exclusion criteria

  • Participants who have Progressive diseases, Head injury, A psychiatric condition , Medical instability, Ventilator dependency, and Presence of tracheostomy

Treatment and study plan

Usual Care

Other

Participants in the control group will recieve usual care.

Primary outcomes

  1. Lung function

    Time frame: at baseline and after 4 week

    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).

  2. Expiratory flow rate during forced expiration

    Time frame: at baseline and after 4 week

    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.

  3. Health-Related Quality of Life (HRQoL)

    Time frame: at baseline and after 4 week

    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.

  4. Perceived exertion and dyspnoea

    Time frame: at baseline and after 4 week

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dolan Chapa Lucky, B.Sc(Hons) in Physiotherapy

CONTACT

[email protected]

+8801972304757

Prof. Dr. Mohammad Anwar Hossain, PhD

CONTACT

[email protected]

+8801753559949

Sponsors and collaborators

Lead sponsor

University of Dhaka

Other

Registry information

Official study title

The Effect of Resistive Inspiratory Muscle Training on Optimizing Lung Function in Individuals With Spinal Cord Injury

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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