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

Post-polio Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064711
• Other study ID #: Tali- HMO-CTIL
• Status: Completed
• Phase: N/A
• First received: February 22, 2017
• Last updated: February 22, 2017
• Start date: January 2013
• Est. completion date: January 2016

Study information

• Verified date: February 2017
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Poliomyelitis
• Post-polio Syndrome
• Postpoliomyelitis Syndrome

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median frequency of electromyography	measure related to fatigue measured during maximal voluntary ventilation	Two hours
Secondary	Pulmonary function	Measured using a body plethysmograph	Two hours
Secondary	maximal inspiratory/expiratory pressures	Measured using ahand-held portable, digital manometer	Two hours