- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05127031
Validity and Reliability of VO2-max Measurements in Persons With Parkinson's Disease
February 20, 2023 updated by: University of Aarhus
Each participant would complete four test days and each test day is separated by 7-10 days.
At each test day the participants would complete a graded maximal exercise test (VO2max-test), a chair rise (Linear encoder) as well as measuring of basic demographic outcomes (weight, fat%,blood pressure etc.).
The first test day would further include a motor (MDS-UPDRS III) and cognitive examination (MoCA), a questionnaire about quality of life (PDQ-39) and one about depression (BDI-II).
Furthermore, the first test day would include two test of walking performance (6 minutes walk test and Time Up and Go).
Two of the test days would be completed while the participants are off their Parkinson disease medication for at least 12 hours, while the other two test days would be completed while on their Parkinson medication.
The order of the tests would be randomized.
It is hypothesized that the VO2max test would be reliable and valid when participants are on medication, while off-medication would affect the reliability and validity.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aarhus, Denmark, 8000
- Sport Science, Department of Public Health, Aarhus University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study population is selected from hospitals in Denmark, including Aarhus University Hospital, Lillebælt Hospital and Odense University Hospital.
Moreover, the population is also selected from private neurological clinics in Esbjerg, Viborg, Aarhus and Skanderborg.
In addition, the study population is recruited via the Danish Parkinson's disease association (including their Facebook website).
Description
Inclusion Criteria:
- Age ≥ 40 year
- Written informed consent
- Diagnosed with idiopathic Parkinson's disease
- Hoehn & Yahr ≤ 3
- Taking dopaminergic medication
- Able to complete a maximal aerobic test on a bicycle
Exclusion Criteria:
- Dementia
- Alcohol abuse
- Pacemaker
- Serious cardiovascular, respiratory, orthopedic or other comorbidities excluding maximal exercise participation.
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VO2max (O2ml/min/kg) change
Time Frame: Up to 40 days
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The maximal oxygen consumption during and graded exercise test.
Used to asses the day to day variation between two test.
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Up to 40 days
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VO2 plateau (Primary validity criterion)
Time Frame: Up to 40 days
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Looking at the difference between the actual measure of VO2 at the end of the VO2-max test and the predicted VO2 calculated using a linear regression.
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Up to 40 days
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Respiratory exchange ratio (RER) (secondary validity criterion)
Time Frame: Up to 40 days
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The ratio between VCO2 (L/min) and VO2 (L/min)
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Up to 40 days
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Blood lactate (secondary validity criterion)
Time Frame: Up to 40 days
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Blood lactate level taken from a fingertip one minute after the VO2max has ended.
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Up to 40 days
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Maximal heart rate (beats/min) (secondary validity criterion)
Time Frame: Up to 40 days
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We would detect the maximal heart rate at the end of the test
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Up to 40 days
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Rating perceived exertion (RPE) (secondary validity criterion)
Time Frame: Up to 40 days
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Using the Borg scala, we would determine the RPE at the end of the test.
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Up to 40 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chair rise - maximal power output (W) change
Time Frame: Up to 40 days
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The maximal power output measured during af chair rise (Linear Encoder).
Using the change between two tests to evaluate the reliability
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Up to 40 days
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Parkinson's Disease Questionnaire (PDQ-39)
Time Frame: At the first test day
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A questionnaire to evaluate the quality of life with scores ranging from 0-100 (higher scores indicating worse quality of life)
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At the first test day
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Beck Depression Inventory-II (BDI-II)
Time Frame: At the first test day
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To evaluate depression.
Scores ranges from 0-63 with higher scores indicating more severe depressive symptoms
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At the first test day
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Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating scale (MDS-UPDRS) III
Time Frame: At the first test day
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A motor examination done by an educated assessor.
Scores ranges from 0-132 with higher scores indicating more severe motor disability.
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At the first test day
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6-minute walk test (6MWT)
Time Frame: At the first test day
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To measure the distance, the participant is able to walk over 6 minutes using a 30 meter track.
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At the first test day
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Timed up and go (TUG)
Time Frame: At the first test day
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Participants have to rise from a chair, walk three meters and go back and sit on the chair again as fast as possible, without running
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At the first test day
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The Montreal Cognitive Assessment (MoCA)
Time Frame: At the first test day
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Participants have to complete different task using the MoCA.
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At the first test day
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Weight (kg)
Time Frame: Four times (one at each visit) during af 40 days period
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We would collect information about weight using bioimpedance sensor (TANITA SC220).
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Four times (one at each visit) during af 40 days period
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Blood pressure (systolic/diastolic) (mmHg)
Time Frame: Four times (one at each visit) during af 40 days period
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Using a blood pressure monitor to ensure that participants do not have a blood pressure above 160/110 mmHg at test day.
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Four times (one at each visit) during af 40 days period
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Date of diagnosis (month and year)
Time Frame: At first visit only
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Collecting information from when participants were diagnosed with Parkinson disease to detect disease duration (years)
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At first visit only
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Medication
Time Frame: At first visit only
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We want to know what type of medication that they use to ensure that participants fulfill the inclusion criterion
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At first visit only
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Actual)
June 1, 2022
Study Completion (Actual)
June 1, 2022
Study Registration Dates
First Submitted
October 27, 2021
First Submitted That Met QC Criteria
November 8, 2021
First Posted (Actual)
November 19, 2021
Study Record Updates
Last Update Posted (Estimate)
February 21, 2023
Last Update Submitted That Met QC Criteria
February 20, 2023
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHP21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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