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

Effects of an optimized respiratory care protocol in patients with amyotrophic lateral sclerosis: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3z23ts
Enrollment
Unknown
Registered
2019-12-17
Start date
2021-03-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic lateral sclerosis, pulmonary capacity, cough

Interventions

A conventional Respiratory Care Group (CC): Guidance and training for caregivers regarding prevention of bronchoaspiration, bed positions, stimulation of mobilization, elimination of secretions with c
upper airway aspiration
elimination of assisted cough secretions using manual or mechanical insufflation
guidance to caregivers regarding prevention of bronchoaspiration, bed positions, stimulation of mobilization, secretion elimination and assisted cough. Each group will have 22 participants, totaling
G12.2
E02.760.169.063.500

Sponsors

Universidade Federal do Rio Grande do Norte
Lead Sponsor
Universidade Federal do Rio Grande do Norte
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Brazil

Contacts

Public ContactKaren Pondofe

Universidade Federal do Rio Grande do Norte

karenpondofe@yahoo.com.br+55(84)999030064

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 15, 2026