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临床试验/NCT06547606
NCT06547606尚未招募不适用

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

University of Dhaka0 个研究点目标入组 60 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Expiratory flow rate during forced expiration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants were allocated to either the intervention group or the control group using a concealed lottery method. Assessors were blinded to the treatments received by participants, ensuring impartial evaluation of outcomes.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • People with Traumatic Cervical Cord Injury
  • Impaired respiratory function

排除标准

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

结局指标

主要结局

Expiratory flow rate during forced expiration

时间窗: 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.

Health-Related Quality of Life (HRQoL)

时间窗: 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.

Lung function

时间窗: 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).

Perceived exertion and dyspnoea

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dolan Chapa Lucky

Principal Investigator

University of Dhaka

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