Activity and Fatigue of the Respiratory Muscles and Pulmonary Characteristics in Post-Polio Patients
Primary Purpose
Post-polio Syndrome
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Electronyugraphy
Sponsored by
About this trial
This is an interventional basic science trial for Post-polio Syndrome
Eligibility Criteria
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
Sites / Locations
- Hadassah Medical Center
Outcomes
Primary Outcome Measures
Median frequency of electromyography
measure related to fatigue measured during maximal voluntary ventilation
Secondary Outcome Measures
Pulmonary function
Measured using a body plethysmograph
maximal inspiratory/expiratory pressures
Measured using ahand-held portable, digital manometer
Full Information
NCT ID
NCT03064711
First Posted
February 22, 2017
Last Updated
February 22, 2017
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT03064711
Brief Title
Activity and Fatigue of the Respiratory Muscles and Pulmonary Characteristics in Post-Polio Patients
Official Title
Comparison of Activity and Fatigue of the Respiratory Muscles and Pulmonary Characteristics Between Post-Polio Patients and Healthy Controls: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-polio Syndrome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Electronyugraphy
Intervention Description
Surface electromyography (sEMG) recorded diaphragmatic muscle activity during rest and while performing maximal voluntary ventilation
Primary Outcome Measure Information:
Title
Median frequency of electromyography
Description
measure related to fatigue measured during maximal voluntary ventilation
Time Frame
Two hours
Secondary Outcome Measure Information:
Title
Pulmonary function
Description
Measured using a body plethysmograph
Time Frame
Two hours
Title
maximal inspiratory/expiratory pressures
Description
Measured using ahand-held portable, digital manometer
Time Frame
Two hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91240
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Activity and Fatigue of the Respiratory Muscles and Pulmonary Characteristics in Post-Polio Patients
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