Post-polio SyndromeNCT03064711
Activity and Fatigue of the Respiratory Muscles and Pulmonary Characteristics in Post-Polio Patients
A study testing Electronyugraphy in people with Post-polio Syndrome, run by Hadassah Medical Organization at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-polio Syndrome
- What is being tested?
- Electronyugraphy
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with post-polio syndrome
- Able to walk for 6 minutes, with or without walking aids and orthotics but without human assistance
Who cannot join
- Any neurological or orthopedic condition, unrelated to post-polio syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Activity and Fatigue of the Respiratory Muscles and Pulmonary Characteristics Between Post-Polio Patients and Healthy Controls: A Pilot Study
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.
Read more
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.
- Conditions
- Post-polio Syndrome
- Being tested
- Electronyugraphy
- Medical subject headings
- Postpoliomyelitis Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectronyugraphyDiagnostic test
Surface electromyography (sEMG) recorded diaphragmatic muscle activity during rest and while performing maximal voluntary ventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
Median frequency of electromyography
measure related to fatigue measured during maximal voluntary ventilation
Measured: Two hours
Secondary outcomes (2)
Pulmonary function
Measured using a body plethysmograph
Measured: Two hours
maximal inspiratory/expiratory pressures
Measured using ahand-held portable, digital manometer
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study startJan 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-polio SyndromeStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabella Shvartz, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064711
- Sponsor's protocol ID
- Tali- HMO-CTIL
- Status last verified
- Feb 2017
- First submitted
- 22 Feb 2017
- Last updated
- 27 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Activity and Fatigue of the Respiratory Muscles and Pulmonary Characteristics Between Post-Polio Patients and Healthy Controls: A Pilot Study
- ClinicalTrials.gov ID
- NCT03064711
- Acronym / sponsor ID
- Tali- HMO-CTIL
- Conditions
- Post-polio Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with post-polio syndrome
- Able to walk for 6 minutes, with or without walking aids and orthotics but without human assistance
Key exclusion criteria (1 listed)
- Any neurological or orthopedic condition, unrelated to post-polio syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectronyugraphySurface electromyography (sEMG) recorded diaphragmatic muscle activity during rest and while performing maximal voluntary ventilation | Diagnostic test | – |
Primary outcome
Median frequency of electromyography
Time frame: Two hours
measure related to fatigue measured during maximal voluntary ventilation
2 secondary outcomes
Pulmonary function
Time frame: Two hours
maximal inspiratory/expiratory pressures
Time frame: Two hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronyugraphy in people with Post-polio Syndrome, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median frequency of electromyography (time frame: Two hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.