RehabGBs: Rehabilitation in People With Guillain-Barré Syndrome

NCT05461898 | Recruiting

• 1 other identifier: RehabGBs
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Guillain-Barré syndrome (GBS) is a neurological disease characterized by an inflammation of peripheral nerves, which might be responsible for long-term disability. Respiratory muscle weakness is a complication of GBS and might be responsible for respiratory symptoms, inadequate secretion clearance or hypoventilation, with negative impact on daily life. Inspiratory muscle training has been applied in respiratory and neurological diseases and benefits have been observed in symptoms (e.g., dyspnoea), pulmonary function, exercise capacity and quality of life. Nevertheless, results of this intervention in people with GBS are yet unknown. Moreover, rehabilitation is a key player in the recovery of these highly complex patients, however, the interpretation of the magnitude of its effects has been limited by the absence of minimal clinically important differences for most outcome measures. To overcome these drawbacks, methodologically robust trials are needed to build evidence-based rehabilitation to improve clinical care on GBS. The primary aim of this project (RehabGBs) is to develop an inspiratory muscle training protocol - InspireGBs and assess its effects on respiratory muscle strength, peak cough flow, pulmonary function, dyspnoea, fatigue, functional status and quality of life in people with GBS, through a randomised controlled trial. Secondary aims are to: i) establish minimal clinically important differences of Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Medical Research Council - Manual Muscle Testing, Vital capacity, Maximal Inspiratory Pressure, Peak Cough Flow, Functional Independence Measure and Quality of Life for inpatient rehabilitation programmes of people with GBS ii) Evaluate the prevalence of nocturnal hypoventilation in GBS.

Conditions

Guillain-Barré Syndrome

Keywords

Rehabilitation; Inspiratory Muscle Training

Outcome Measures

Primary Outcomes (1)

• Change in maximal inspiratory pressure

  Respiratory muscle strength will be assessed with maximal respiratory pressure tests

  6 weeks

Secondary Outcomes (6)

• Change in maximal expiratory pressure

  6 weeks

• Change in Peak cough flow

  6 weeks

• Change in Nocturnal transcutaneous carbon dioxide and peripheral oxygen saturation

  6 weeks

• Change in Medical Research Council - Manual Muscle Testing

  6 weeks

• Change in Functional Assessment of Chronic Illness Therapy-Fatigue Subscale

  6 weeks

Study Arms (2)

Inpatient Rehabilitation + Inspiratory Muscle Training

EXPERIMENTAL

* The inpatient rehabilitation program included individualized, functional goal-oriented treatment, with approximately 5 hours of intervention a day, 5 days/week for a total of 6 weeks, with integrated rehabilitation care. * The inspiratory muscle training included a 6 weeks intervention with electronic-controlled valve device

Other: Inpatient Rehabilitation; Other: Inspiratory muscle training

Inpatient Rehabilitation

ACTIVE COMPARATOR

\- The inpatient rehabilitation program included individualized, functional goal-oriented treatment, with approximately 5 hours of intervention a day, 5 days/week for a total of 6 weeks, with integrated rehabilitation care.

Other: Inpatient Rehabilitation

Interventions

Inpatient Rehabilitation OTHER

Standard inpatient rehabilitation program with a interdisciplinary team that included a physiotherapist who ensured muscle strength, balance, aerobic and functional training, an occupational therapist who provided training of basic and instrumental activities of daily living and education of energy conservation techniques and a a speech and language therapist for swallowing training.

Inpatient Rehabilitation; Inpatient Rehabilitation + Inspiratory Muscle Training

Inspiratory muscle training OTHER

Inspiratory muscle training protocol during 6 weeks with a electronic-controlled valve device

Inpatient Rehabilitation + Inspiratory Muscle Training

Eligibility Criteria

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

You may qualify if:

• ≥18 years
• diagnosed with Guillain Barré Syndrome
• willing to participate in an inpatient rehabilitation program
• able to provide informed consent

You may not qualify if:

• presence of significant cardiac and musculoskeletal diseases
• tracheostomized patients
• signs of cognitive impairment or current neoplastic or immunological disease which may preclude their participation in the rehabilitation program and participation in any other therapeutic intervention in addition to standard of care.

Sponsors & Collaborators

• Centro de Reabilitacao do Norte: lead
• Aveiro University: collaborator

Study Sites (1)

Centro de Reabilitação do Norte

Vila Nova de Gaia, 4405 - 565, Portugal

RECRUITING

Related Publications (32)

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MeSH Terms

Conditions

Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alda S Marques, PhD

  School of Health Sciences, University of Aveiro (ESSUA)

  STUDY DIRECTOR

Central Study Contacts

Miguel P Almeida, MSc

CONTACT

00351919523101; miguelalmeida.ft@gmail.com

Sofia A Viamonte, MSc

CONTACT

00351220901200

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 18, 2022
• Study Start: January 1, 2023
• Primary Completion: October 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 4, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)