Effects of a protocol of respiratory care in patients with Amyotrophic Lateral Sclerosis

Not Applicable

• Conditions: Amyotrophic lateral sclerosis, pulmonary capacity, cough; G00-G99

• Registration Number: RBR-3z23ts
• Lead Sponsor: niversidade Federal do Rio Grande do Norte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-17
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria for the study were patients with ALS, between 18 and 70 years old, with good cognitive level to understand the evaluative tests; patients not restricted to bed; the presence of a responsible caregiver who accepts the training and follows the program; have a telephone to contact the service team.

Exclusion Criteria

Will be excluded from the study volunteers who are unable to perform the requested maneuvers correctly or who give up performing them during the execution for evaluation. Patients with cardiac, respiratory, musculoskeletal comorbidities, intellectual comprehension difficulty or dementia evaluated, with any other comorbidity that prevents them from performing the tests or who have difficulty performing the tests; and, smoking patients. Patients residing in regions that do not have rear medical staff in the city or in a nearby urban center; patients residing in regions of high hazard or difficult for physiotherapists to access.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak cough flow in liters/minute by optoelectronic plethysmograph analysis.;Physical function through the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised - ALSFRS-R.;Number of exacerbations (acute) of the patients through urgent and emergency medical assistance.

Secondary Outcome Measures

Name	Time	Method
Chest wall kinematics during Cough Assist assisted coughing by optoelectronic plethysmography (BTS Bioengineering, Italy).;The absolute and predicted Forced Vital Capacity (FVC), forced expiratory volume in the 1st second (FEV1) and FEV1/FVC by spirometry.;Respiratory muscle strength through maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), sniff nasal inspiratory pressure (SNIP) and nasal expiratory pressure using the manovacuometer.;Demographic (age and gender), anthropometric assessments (height and weight) and body mass index