Inspiratory Muscle Training in Multiple Sclerosis

NCT03887546 | Unknown

• 1 other identifier: 24121989
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: To evaluate the effectiveness of a low-intensity protocol of inspiratory muscle training (IMT) to improve respiratory strength, spirometric parameters and dyspnea in patients with multiple sclerosis (MS). Design: Clinical trial. Randomized. Participants: 67 patients with MS, distributed in two groups, intervention and control. Intervention: Intervention group train using IMT for 12 weeks, 5 days/week, 15 minutes/day (20% maximum inspiratory pressure (MIP) during the first two weeks and 30% MIP after the second week). Control group follow a respiratory exercise program involving nasal breathing and maximum exhalation during 12 weeks, 5 days/week, 15 minutes/day. Evaluations: Determination of the MIP and the maximum expiratory pressure (MEP); spirometry - maximum voluntary ventilation (MVV), peak expiratory flow (PEF), tidal volume (TV); dyspnea using the Borg scale and clinical evaluations.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Rehabilitation; Respiration; Breathing exercise; Fatigue

Outcome Measures

Primary Outcomes (2)

• Maximal inspiratory pressure (MIP)

  The evaluation is performed using a pressure transducer, Elka 15, which obtainer each measurement in millibar and converted it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O), following the rules of the ATS / ERS. The procedure was repeated until 3 values were obtained with a difference of less than 5%, and the highest value was used for the analysis. The MIP of the intervention group was assessed every 2 weeks to set the IMT workload.

  5 minutes

• Maximal expiratory pressure (MEP)

  The evaluation is performed using a pressure transducer, Elka 15. It is evaluated at the beginning and at the end of the interventional phase. Measure: cm H20

  5 minutes

Secondary Outcomes (8)

• Dyspnea

  1 minute

• Maximum voluntary ventilation (MVV)

  1 minute

• Forced expiratory volume in the first second (FEV1)

  1 minute

• Peak expiratory flow (PEF)

  1 minute

• Mean expiratory flow (FEF25-75)

  1 minute

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention is administrated with Inspiratory Muscle Trainer. 20% maximum inspiratory pressure (MIP) during the first two weeks and 30% MIP after the second week. 12 weeks, 5 days/week, 15 minutes/day.

Device: Inspiratory muscle trainer

Control group

ACTIVE COMPARATOR

Respiratory exercise program involving nasal breathing and maximum exhalation during 12 weeks, 5 days/week, 15 minutes/day

Procedure: Respiratory exercise

Interventions

Inspiratory muscle trainer DEVICE

The device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O).

Intervention group

Respiratory exercise PROCEDURE

Respiratory exercise program involving nasal breathing and maximum exhalation during 12 weeks, 5 days/week, 15 minutes/day.

Control group

Eligibility Criteria

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

You may qualify if:

• Diagnosed with MS
• Over 18 years old
• Disability lower than 9 in the EDSS
• Be able to understand the objectives of the study

You may not qualify if:

• Participants with a current or past neurological pathology other than MS
• Relapse of MS or any respiratory pathology during the 4 weeks prior to the start of the study
• Any other complication that may impede the performance of the evaluation tests or breathing techniques

Sponsors & Collaborators

• University of Salamanca: lead

MeSH Terms

Conditions

Multiple Sclerosis; Respiratory Aspiration; Fatigue

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• ANA MARIA MARTIN-NOGUERAS, DR

  University of Salamanca

  STUDY CHAIR

Central Study Contacts

CARLOS MARTIN SANCHEZ, DOCTOR

CONTACT

+34646774655; carlos_ms@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The principal investigator doesn´t know the group of the patients until the study ends.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Patients are assigned randomly to the two working groups, each patient only receives one of the two protocols.

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: March 25, 2019
• Study Start: April 23, 2019
• Primary Completion: July 24, 2019
• Study Completion: September 15, 2019
• Last Updated: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share