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

August 7, 2024 updated by: Dolan Chapa Lucky, University of Dhaka

The Effect of Resistive Inspiratory Muscle Training on Optimizing Lung Function in Individuals With 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

  1. Incentive Spirometry: Assesses lung function.
  2. Peak Flow Meter: Measures Peak Expiratory Flow (PEF), assessing expiratory flow rate during forced expiration.
  3. SF-12 Health Survey: Assesses health-related quality of life (HRQoL) across various physical and mental health aspects.
  4. Modified Borg Scale: Subjective assessment of perceived exertion and dyspnoea.
  5. 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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dolan Chapa Lucky, B.Sc(Hons) in Physiotherapy
  • Phone Number: +8801972304757
  • Email: dcl.mrs7@gmail.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resistive Inspiratory Muscle Training
Participants in this group will perform resistive inspiratory muscle training, designed to strengthen respiratory muscles and improve lung function. Training involves inhaling through a device that provides resistance, performed five days a week for four weeks.
Other: Usual Care
Participants in the control group will recieve usual care.
Active Comparator: Usual Care
Participants in this group will receive conservative respiratory physiotherapy, which includes standard techniques aimed at maintaining respiratory function and managing symptoms.
Other: Usual Care
Participants in the control group will recieve usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
at baseline and after 4 week
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.
at baseline and after 4 week
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.
at baseline and after 4 week
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.
at baseline and after 4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dhaka

Investigators

  • Study Chair: Prof. Dr. Mohammad Anwar Hossain, PhD, Professor & Head of Department of Physiotherapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRP-BHPI/IRB/07/2024/900

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participants' demographic details, such as their names and contact information, will be kept confidential by the primary investigator until the publication of the study results. After publication, this information will be discarded.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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