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

NCT06547606 | Not Yet Recruiting DMC

• 1 other identifier: CRP-BHPI/IRB/07/2024/900
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Spinal Cord Injury (SCI), Respiratory Complication

Keywords

SCI, Respiratory complication, Lung Function, RIMT, Conventional Physiotherapy

Outcome Measures

Primary Outcomes (4)

• 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).

  at baseline and after 4 week

• 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.

  at baseline and after 4 week

• 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.

  at baseline and after 4 week

• 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.

  at baseline and after 4 week

Study Arms (2)

Resistive Inspiratory Muscle Training

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

Participants in this group will receive conservative respiratory physiotherapy, which includes standard techniques aimed at maintaining respiratory function and managing symptoms.

Other: Usual Care

Interventions

Usual Care OTHER

Participants in the control group will recieve usual care.

Resistive Inspiratory Muscle Training; Usual Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People with Traumatic Cervical Cord Injury
• Impaired respiratory function

You may not qualify if:

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

Sponsors & Collaborators

• University of Dhaka: lead

Related Publications (6)

• Gee CM, Williams AM, Sheel AW, Eves ND, West CR. Respiratory muscle training in athletes with cervical spinal cord injury: effects on cardiopulmonary function and exercise capacity. J Physiol. 2019 Jul;597(14):3673-3685. doi: 10.1113/JP277943. Epub 2019 Jun 11.

  PMID: 31115056 BACKGROUND

• McDonald T, Stiller K. Inspiratory muscle training is feasible and safe for patients with acute spinal cord injury. J Spinal Cord Med. 2019 Mar;42(2):220-227. doi: 10.1080/10790268.2018.1432307. Epub 2018 Feb 5.

  PMID: 29400990 BACKGROUND

• de Araujo Morais L, Cipriano G Jr, Martins WR, Chiappa GR, Formiga MF, Cipriano GFB. Inspiratory muscle training on quality of life in individuals with spinal cord injury: A systematic review and meta-analysis. Spinal Cord. 2023 Jul;61(7):359-367. doi: 10.1038/s41393-023-00906-1. Epub 2023 Jul 1.

  PMID: 37393409 BACKGROUND

• Palermo AE, Butler JE, Boswell-Ruys CL. Comparison of two inspiratory muscle training protocols in people with spinal cord injury: a secondary analysis. Spinal Cord Ser Cases. 2023 Aug 12;9(1):42. doi: 10.1038/s41394-023-00594-2.

  PMID: 37573384 RESULT

• Postma K, Haisma JA, Hopman MT, Bergen MP, Stam HJ, Bussmann JB. Resistive inspiratory muscle training in people with spinal cord injury during inpatient rehabilitation: a randomized controlled trial. Phys Ther. 2014 Dec;94(12):1709-19. doi: 10.2522/ptj.20140079. Epub 2014 Jul 31.

  PMID: 25082923 RESULT

• Palermo AE, Cahalin LP, Nash MS. A case for inspiratory muscle training in SCI: potential role as a preventative tool in infectious respiratory diseases like COVID-19. Spinal Cord Ser Cases. 2020 Sep 17;6(1):87. doi: 10.1038/s41394-020-00337-7.

  PMID: 32943611 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Prof. Dr. Mohammad Anwar Hossain, PhD

  Professor & Head of Department of Physiotherapy

  STUDY CHAIR

Central Study Contacts

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

CONTACT

+8801972304757; dcl.mrs7@gmail.com

Prof. Dr. Mohammad Anwar Hossain, PhD

CONTACT

+8801753559949; anwar_physiobd@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a double-blinded randomized controlled trial (RCT), where both participants and assessors were blinded. Participants were randomly allocated to either the experimental group, receiving resistive inspiratory muscle training, or the control group, receiving usual care, allocated using a lottery method.

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: August 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share