Respiratory Muscle Training in Adults With Spinal Cord Injury

NCT05904600 | Unknown DMC

• 1 other identifier: FFEHNP
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injuries; Breathing exercises; Respiratory muscle training

Outcome Measures

Primary Outcomes (2)

• 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 after 6 weeks of intervention compared to baseline

• 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.

  Change after 6 weeks of intervention compared to baseline

Secondary Outcomes (8)

• Change in forced vital capacity (FVC)

  Change after 6 weeks of intervention compared to baseline

• Change in coughing capacity

  Change after 6 weeks of intervention compared to baseline

• Change in elbow flexion strength

  Change after 6 weeks of intervention compared to baseline

• Change in shoulder flexion strength

  Change after 6 weeks of intervention compared to baseline

• Change in number of people with respiratory complications

  Change after 6 weeks of intervention compared to baseline

Study Arms (2)

Respiratory muscle training

EXPERIMENTAL

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.

Device: Respiratory muscle training

Control group

SHAM COMPARATOR

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

Device: Control group

Interventions

Respiratory muscle training DEVICE

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.

Respiratory muscle training

Control group DEVICE

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Hospital Nacional de Parapléjicos de Toledo: collaborator

Study Sites (1)

Sara Reina Gutiérrez

Toledo, 45071, Spain

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Breathing Exercises; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ana Torres-Costoso

  University of Castilla-La Mancha

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Reina-Gutiérrez

CONTACT

969179100; sara.reina@uclm.es

Ana Torres-Costoso

CONTACT

925268800; anaisabel.torres@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 15, 2023
• Study Start: August 30, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: June 15, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)