Breath Stacking Technique Associated With Expiratory Muscle Training in Amyotrophic Lateral Sclerosis Patients

NCT ID: NCT04226144

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2022-12-01

Brief Summary

it will be conducted a randomized parallel controlled trial with patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) to compare two techniques to lung recruitment and cough augmentation, to assess their effects on pulmonary function, global functionally, swallowing and ability to speech in these population.

Detailed Description

age over 18 years preserved cognition, evidenced by a score greater than or equal to 24 points in the Mini-Mental Status Exam; no barium allergies; without tracheostomy or invasive mechanical ventilation; no diaphragmatic pacemaker and without associated respiratory disease.Participants are excluded if they have pregnancy; previous kidney disease or other concomitant diseases; respiratory diseases and hospitalization in intensive care units (ICUs) during the study.

Conditions

Amyotrophic Lateral Sclerosis; Neuromuscular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Breath Stacking Group

The lungs are inflated as fully as possible by stacking successive breaths without expiration until the patients' maximal inspiratory capacity (MIC). The participant will be instructed to sustain the air in the lung, closing the glottis. Once the lungs are maximally inflated, the compressed air volume is released under expiratory muscle force, thus generating a cough with lung and chest wall recoil. They will perform 5-8 cycles of breath stacking per session, stacking 3-5 breaths per cycle.

Group Type: ACTIVE_COMPARATOR

Breath Stacking Group

Intervention Type: DEVICE

Lung recruitment technique using manual bag resuscitation with oronasal mask interface

Breath stacking and EMT

This group will perform the breath stacking technique in addiction with EMT. It will change the one-way valve in this group to VUP (Lumiar, Sao Paulo, Brazil) one-way valve, which allows the patients blow out the air with a counter resistance during all expiratory phase. The initial expiratory pressure will be 8 cmH2O, and could be changed at each visit according to participants' tolerance (either report easy or difficult to exhale assessed by research coordinators. The participants are encouraged to blow out the most slowly that they can do it.

Group Type: EXPERIMENTAL

Breath stacking and EMT

Intervention Type: DEVICE

Lung recruitment technique with one way valve with counter resistance during all expiratory phase

Interventions

Breath Stacking Group

Lung recruitment technique using manual bag resuscitation with oronasal mask interface

Intervention Type: DEVICE

Breath stacking and EMT

Lung recruitment technique with one way valve with counter resistance during all expiratory phase

Intervention Type: DEVICE

Other Intervention Names

lung recruitment technique; VUP

Eligibility Criteria

Inclusion Criteria

• diagnosis of neuromuscular disease confirmed by neurologists at the referral center for neuromuscular diseases at Brasília prior to screening for recruitment
• age over 18 years
• preserved cognition, evidenced by a score greater than or equal to 24 points in the Mini-Mental Status Exam;
• no barium allergies
• without tracheostomy or invasive mechanical ventilation
• no diaphragmatic pacemaker
• without associated respiratory disease

Exclusion Criteria

• pregnancy
• previous kidney disease or other concomitant diseases .respiratory diseases and hospitalization in intensive care units (ICUs) during the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Escola Superior de Ciencias da Saude

OTHER

Sponsor Role: lead

Responsible Party

Vinicius Zacarias Maldaner da silva

PT, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vinicius Maldaner

Role: PRINCIPAL_INVESTIGATOR

Hospital de Apoio de Brasilia

Locations

Hospital de Apoio de Brasilia

Brasília, Federal District, Brazil

Countries

Brazil

References

Dorca A, Alcantara LA, Diniz DS, Sarmet M, Menezes Mateus SR, Franco Oliveira LV, Franco H, Maldaner V. Comparison between breath stacking technique associated with expiratory muscle training and breath stacking technique in amyotrophic lateral sclerosis patients: Protocol for randomized single blind trial. Contemp Clin Trials Commun. 2020 Sep 2;19:100647. doi: 10.1016/j.conctc.2020.100647. eCollection 2020 Sep.

Reference Type: DERIVED

PMID: 33005816 (View on PubMed)

Other Identifiers

EMTBTALS

Identifier Type: -

Identifier Source: org_study_id