Activity and Fatigue of the Respiratory Muscles and Pulmonary Characteristics in Post-Polio Patients
Comparison of Activity and Fatigue of the Respiratory Muscles and Pulmonary Characteristics Between Post-Polio Patients and Healthy Controls: A Pilot Study
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 22, 2017
CompletedFirst Posted
Study publicly available on registry
February 27, 2017
CompletedFebruary 27, 2017
February 1, 2017
3 years
February 22, 2017
February 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Median frequency of electromyography
measure related to fatigue measured during maximal voluntary ventilation
Two hours
Secondary Outcomes (2)
Pulmonary function
Two hours
maximal inspiratory/expiratory pressures
Two hours
Interventions
Surface electromyography (sEMG) recorded diaphragmatic muscle activity during rest and while performing maximal voluntary ventilation
Eligibility Criteria
You may qualify if:
- Diagnosed with post-polio syndrome
- Able to walk for 6 minutes, with or without walking aids and orthotics but without human assistance
You may not qualify if:
- Any neurological or orthopedic condition, unrelated to post-polio syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Center
Jerusalem, 91240, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 22, 2017
First Posted
February 27, 2017
Study Start
January 1, 2013
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
February 27, 2017
Record last verified: 2017-02