Activity and Fatigue of the Respiratory Muscles and Pulmonary Characteristics in Post-Polio Patients

Not Applicable

Completed

• Conditions: Post-polio Syndrome

• Registration Number: NCT03064711
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

Background: Early diagnosis of respiratory impairment in Post-Polio (PPS) patients may delay respiratory decline and future need of invasive respiratory aids.

Objectives: To compare pulmonary function measures, maximal respiratory pressure and activity levels and fatigue of respiratory muscles between patients with PPS and healthy controls.

Design: Cross-sectional study. Setting: Hadassah physical medicine and rehabilitation department, Jerusalem. Patients: Patients with PPS (N=12; 6 males; age 62.1±11.6 years) able to walk for 6 minutes without human assistance; age-matched healthy subjects (N=12; 4 males; age 62.2±6.5 years).

Intervention: None. Measurements: A body plethysmograph was used to quantify forced expiratory volume in the first second of a forced expiratory maneuver, vital capacity, slow vital capacity, Residual Volume (RV), Total Lung Capacity (TLC), and Thoracic Gas Volume (TGV). Also, RV to TLC ratio is calculated. A manometer was used to measure Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP). A spirometer was used to measure Maximal Voluntary Ventilation (MVV). Surface electromyography (sEMG) recorded diaphragmatic muscle activity during rest and while performing MVV.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-02
• Study First Submitted: 2017-02-22
• Study First Submitted QC: 2017-02-22
• Last Update Submitted: 2017-02-22
• Study First Posted: 2017-02-27
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Diagnosed with post-polio syndrome
• Able to walk for 6 minutes, with or without walking aids and orthotics but without human assistance

Exclusion Criteria

• Any neurological or orthopedic condition, unrelated to post-polio syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Median frequency of electromyography	Two hours	measure related to fatigue measured during maximal voluntary ventilation

Secondary Outcome Measures

Name	Time	Method
Pulmonary function	Two hours	Measured using a body plethysmograph
maximal inspiratory/expiratory pressures	Two hours	Measured using ahand-held portable, digital manometer

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel