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Respiratory Muscle Training in Adults With Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Respiratory muscle training
Control group
Sponsored by
University of Castilla-La Mancha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal Cord Injuries, Breathing exercises, Respiratory muscle training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: People diagnosed with spinal cord injury. Over 18 years of age. Time of evolution less than 6 months and at least 4 weeks after the date of injury. Level of lesion between C5 and D5 and degree of involvement A or B. In case of involvement A with partial preservation zone this should not include abdominal musculature according to the international standardised classification of the American Spinal Injury Association. Exclusion Criteria: People with chest trauma. Mechanically ventilated. Pregnant women. Any medical or psychiatric condition that could affect the ability to complete the study. Carrying a tracheostomy tube that does not tolerate occlusion. People who can not sit upright.

Sites / Locations

  • Sara Reina GutiérrezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Respiratory muscle training

Control group

Arm Description

Respiratory muscle training with the Orygen-Dual Valve (Forumed S.L. ESP) and an initial load of 30% of their maximum inspiratory and expiratory pressures.

Simulated training with the Orygen-Dual Valve (Forumed S.L. ESP), without load.

Outcomes

Primary Outcome Measures

Change in maximal expiratory pressure
The measurement of maximum static respiratory pressures will consist of performing maximum forced inspiration and expiration manoeuvres against an occluded airway in order to measure the pressure generated in the mouth, using a manometer or a pressure transducer, since, with the glottis open, the pressure in the mouth must be equal to the alveolar pressure.
Change in maximal inspiratory pressure
The measurement of maximum static respiratory pressures will consist of performing maximum forced inspiration and expiration manoeuvres against an occluded airway in order to measure the pressure generated in the mouth, using a manometer or a pressure transducer, since, with the glottis open, the pressure in the mouth must be equal to the alveolar pressure.

Secondary Outcome Measures

Change in forced vital capacity (FVC)
Using a spirometer, with the mouthpiece tightly sealed around the lips, the participant is asked, from the residual volume, to perform a rapid but unforced maximal inspiratory manoeuvre. With an apnoea of less than one second at total lung capacity, the participant is asked to exhale maximally, rapidly and forcibly, until the lungs are completely empty. At this point, the participant is strongly encouraged to start the manoeuvre abruptly and to prolong the exhalation long enough to reach RV.
Change in coughing capacity
Measurement of cough capacity will be performed by determining peak cough flow using a peak expiratory flow meter (Mini Wright flow meter; Clement Clarke International Ltd., Essex, UK).
Change in elbow flexion strength
In all subjects, the maximum load they can move in one repetition (1RM) in both limbs will be assessed for elbow flexion with Microfet4 dynamometer; Hoggan Health Industries, West Jordan, Utah.
Change in shoulder flexion strength
In all subjects, the maximum load they can move in one repetition (1RM) in both limbs will be assessed for shoulder flexion with Microfet4 dynamometer; Hoggan Health Industries, West Jordan, Utah.
Change in number of people with respiratory complications
Respiratory complications will be assessed by consulting the medical history.
Change in health-related quality of life assessed by Short-Form 36 questionnaire.
Health-related quality of life will be measured with the Short-Form 36 questionnaire, with values ranging from 0 to 100 (higher scores mean better health-related quality of life).
Change in forced expiratory volume in the first second (FEV1)
Using a spirometer, with the mouthpiece tightly sealed around the lips, the participant is asked, from the residual volume, to perform a rapid but unforced maximal inspiratory manoeuvre. With an apnoea of less than one second at total lung capacity, the participant is asked to exhale maximally, rapidly and forcibly, until the lungs are completely empty. At this point, the participant is strongly encouraged to start the manoeuvre abruptly and to prolong the exhalation long enough to reach RV.
Change in cardiorespiratory fitness
Cardiorespiratory fitness will be measured using the 6-minute wheelchair propulsion test (adapted from Bass A et al. 2020). This is a validated test to measure cardiorespiratory fitness through a submaximal exercise test where the patient performs a 25-metre figure-eight run for 6 minutes and the distance covered in that time is recorded.

Full Information

First Posted
May 11, 2023
Last Updated
June 12, 2023
Sponsor
University of Castilla-La Mancha
Collaborators
Hospital Nacional de Parapléjicos de Toledo
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1. Study Identification

Unique Protocol Identification Number
NCT05904600
Brief Title
Respiratory Muscle Training in Adults With Spinal Cord Injury
Official Title
Respiratory Muscle Training to Improve Functional Capacity and Prevent Respiratory Complications in Adults With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Castilla-La Mancha
Collaborators
Hospital Nacional de Parapléjicos de Toledo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the effectiveness of a programme based on inspiratory and expiratory muscle training to improve respiratory muscle strength, functional capacity and avoid pulmonary complications in adults with cervical or high dorsal spinal cord injury (C5-D5) in acute phase.
Detailed Description
The design of the study is a randomised, triple-blind clinical trial with a control group. The size of the sample will be 56 participants with cervical spinal cord injury and 56 with dorsal spinal cord injury. They will be randomized in two groups: experimental or control. The experimental group will perform combined inspiratory and expiratory muscle training as part of their rehabilitation programme during 6 weeks. The control group will continue their usual treatment. Measurements will be taken at baseline, and post-intervention. The statistical analysis will be an intention-to-treat analysis, and the data processing and analysis will be carried out with the Statistical Package for the Social Sciences (SPSS) version 24.0 for Windows (Armonk, NY: IBM Corp.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal Cord Injuries, Breathing exercises, Respiratory muscle training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Masking of the researchers: randomisation of the sample will be performed using STATA software by a member of the research team who will not be involved in patient recruitment or data collection. The interventions will be carried out by researchers different from those who will perform the evaluation of the outcomes. Masking of the participants: the control group will have a training of the respiratory muscles simulated with the same device as the intervention group. They will use the device without load and with an opaque adhesive tape surrounding the device to mask the valve position.
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Respiratory muscle training
Arm Type
Experimental
Arm Description
Respiratory muscle training with the Orygen-Dual Valve (Forumed S.L. ESP) and an initial load of 30% of their maximum inspiratory and expiratory pressures.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Simulated training with the Orygen-Dual Valve (Forumed S.L. ESP), without load.
Intervention Type
Device
Intervention Name(s)
Respiratory muscle training
Intervention Description
The training of the intervention group will have an initial workload of 30% of maximal inspiratory and expiratory pressures, which will be increased weekly by 10% according to tolerance, if not tolerated by 5%. In addition, patients will be instructed to maintain a normal respiratory rate (12-16 breaths per minute). Moreover, they will continue their usual treatment.
Intervention Type
Device
Intervention Name(s)
Control group
Intervention Description
In the control group, the respiratory muscle training will be simulated by using the device without load throughout the study period using an opaque adhesive tape surrounding the device to mask the valve position.
Primary Outcome Measure Information:
Title
Change in maximal expiratory pressure
Description
The measurement of maximum static respiratory pressures will consist of performing maximum forced inspiration and expiration manoeuvres against an occluded airway in order to measure the pressure generated in the mouth, using a manometer or a pressure transducer, since, with the glottis open, the pressure in the mouth must be equal to the alveolar pressure.
Time Frame
Change after 6 weeks of intervention compared to baseline
Title
Change in maximal inspiratory pressure
Description
The measurement of maximum static respiratory pressures will consist of performing maximum forced inspiration and expiration manoeuvres against an occluded airway in order to measure the pressure generated in the mouth, using a manometer or a pressure transducer, since, with the glottis open, the pressure in the mouth must be equal to the alveolar pressure.
Time Frame
Change after 6 weeks of intervention compared to baseline
Secondary Outcome Measure Information:
Title
Change in forced vital capacity (FVC)
Description
Using a spirometer, with the mouthpiece tightly sealed around the lips, the participant is asked, from the residual volume, to perform a rapid but unforced maximal inspiratory manoeuvre. With an apnoea of less than one second at total lung capacity, the participant is asked to exhale maximally, rapidly and forcibly, until the lungs are completely empty. At this point, the participant is strongly encouraged to start the manoeuvre abruptly and to prolong the exhalation long enough to reach RV.
Time Frame
Change after 6 weeks of intervention compared to baseline
Title
Change in coughing capacity
Description
Measurement of cough capacity will be performed by determining peak cough flow using a peak expiratory flow meter (Mini Wright flow meter; Clement Clarke International Ltd., Essex, UK).
Time Frame
Change after 6 weeks of intervention compared to baseline
Title
Change in elbow flexion strength
Description
In all subjects, the maximum load they can move in one repetition (1RM) in both limbs will be assessed for elbow flexion with Microfet4 dynamometer; Hoggan Health Industries, West Jordan, Utah.
Time Frame
Change after 6 weeks of intervention compared to baseline
Title
Change in shoulder flexion strength
Description
In all subjects, the maximum load they can move in one repetition (1RM) in both limbs will be assessed for shoulder flexion with Microfet4 dynamometer; Hoggan Health Industries, West Jordan, Utah.
Time Frame
Change after 6 weeks of intervention compared to baseline
Title
Change in number of people with respiratory complications
Description
Respiratory complications will be assessed by consulting the medical history.
Time Frame
Change after 6 weeks of intervention compared to baseline
Title
Change in health-related quality of life assessed by Short-Form 36 questionnaire.
Description
Health-related quality of life will be measured with the Short-Form 36 questionnaire, with values ranging from 0 to 100 (higher scores mean better health-related quality of life).
Time Frame
Change after 6 weeks of intervention compared to baseline
Title
Change in forced expiratory volume in the first second (FEV1)
Description
Using a spirometer, with the mouthpiece tightly sealed around the lips, the participant is asked, from the residual volume, to perform a rapid but unforced maximal inspiratory manoeuvre. With an apnoea of less than one second at total lung capacity, the participant is asked to exhale maximally, rapidly and forcibly, until the lungs are completely empty. At this point, the participant is strongly encouraged to start the manoeuvre abruptly and to prolong the exhalation long enough to reach RV.
Time Frame
Change after 6 weeks of intervention compared to baseline
Title
Change in cardiorespiratory fitness
Description
Cardiorespiratory fitness will be measured using the 6-minute wheelchair propulsion test (adapted from Bass A et al. 2020). This is a validated test to measure cardiorespiratory fitness through a submaximal exercise test where the patient performs a 25-metre figure-eight run for 6 minutes and the distance covered in that time is recorded.
Time Frame
Change after 6 weeks of intervention compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: People diagnosed with spinal cord injury. Over 18 years of age. Time of evolution less than 6 months and at least 4 weeks after the date of injury. Level of lesion between C5 and D5 and degree of involvement A or B. In case of involvement A with partial preservation zone this should not include abdominal musculature according to the international standardised classification of the American Spinal Injury Association. Exclusion Criteria: People with chest trauma. Mechanically ventilated. Pregnant women. Any medical or psychiatric condition that could affect the ability to complete the study. Carrying a tracheostomy tube that does not tolerate occlusion. People who can not sit upright.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Reina-Gutiérrez
Phone
969179100
Ext
4691
Email
sara.reina@uclm.es
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Torres-Costoso
Phone
925268800
Ext
5825
Email
anaisabel.torres@uclm.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Torres-Costoso
Organizational Affiliation
University of Castilla-La Mancha
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sara Reina Gutiérrez
City
Toledo
ZIP/Postal Code
45071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Reina-Gutiérrez
Phone
969179100
Ext
4691
Email
sara.reina@uclm.es
First Name & Middle Initial & Last Name & Degree
Ana Torres-Costoso
Phone
925268800
Ext
5825
Email
anaisabel.torres@uclm.es

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only the research team, and the health authorities, who have a duty of confidentiality, will have access to all data collected by the study. Information that cannot be identified may be passed on to third parties.

Learn more about this trial

Respiratory Muscle Training in Adults With Spinal Cord Injury

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