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

NCT03064711 — Not applicable, Completed, 24 participants, Hadassah Medical Organization

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Comparison of Activity and Fatigue of the Respiratory Muscles and Pulmonary Characteristics Between Post-Polio Patients and Healthy Controls: A Pilot Study

Registry	NCT03064711
Status	Completed
Phase	Not applicable
Study type	Interventional; parallel, masking: none, basic science
Enrollment	24 (Actual)
Sponsor	Hadassah Medical Organization (Other)
Conditions	Post-polio Syndrome
Interventions	Electronyugraphy (Diagnostic test)
Dates	start 2013-01-01, primary completion 2016-01-01, completion 2016-01-01, first posted 2017-02-27, last updated 2017-02-27
Locations	1 site in Israel

-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.

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+Arms and interventions

Electronyugraphy (Diagnostic test): Surface electromyography (sEMG) recorded diaphragmatic muscle activity during rest and while performing maximal voluntary ventilation

+Outcome measures

Primary outcomes

Median frequency of electromyography [Two hours]: measure related to fatigue measured during maximal voluntary ventilation

Secondary outcomes

Pulmonary function [Two hours]: Measured using a body plethysmograph
maximal inspiratory/expiratory pressures [Two hours]: Measured using ahand-held portable, digital manometer

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Hadassah Medical Center	Jerusalem	Israel