Parkinson DiseaseNCT05127031
Validity and Reliability of VO2-max Measurements in Persons With Parkinson's Disease
An observational study of Parkinson Disease, run by University of Aarhus at 1 site in Denmark.
Trial summary
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.). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson Disease
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2021to 1 Jun 2022
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Dementia
- Alcohol abuse
- Pacemaker
- Serious cardiovascular, respiratory, orthopedic or other comorbidities excluding maximal exercise participation.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Sport Science, Department of Public Health, Aarhus University
Aarhus, 8000
About this study
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.
- Conditions
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max (O2ml/min/kg) change
The maximal oxygen consumption during and graded exercise test. Used to asses the day to day variation between two test.
Measured: Up to 40 days
VO2 plateau (Primary validity criterion)
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.
Measured: Up to 40 days
Respiratory exchange ratio (RER) (secondary validity criterion)
The ratio between VCO2 (L/min) and VO2 (L/min)
Measured: Up to 40 days
Blood lactate (secondary validity criterion)
Blood lactate level taken from a fingertip one minute after the VO2max has ended.
Measured: Up to 40 days
Maximal heart rate (beats/min) (secondary validity criterion)
We would detect the maximal heart rate at the end of the test
Measured: Up to 40 days
Rating perceived exertion (RPE) (secondary validity criterion)
Using the Borg scala, we would determine the RPE at the end of the test.
Measured: Up to 40 days
Secondary outcomes (11)
Chair rise - maximal power output (W) change
The maximal power output measured during af chair rise (Linear Encoder). Using the change between two tests to evaluate the reliability
Measured: Up to 40 days
Parkinson's Disease Questionnaire (PDQ-39)
A questionnaire to evaluate the quality of life with scores ranging from 0-100 (higher scores indicating worse quality of life)
Measured: At the first test day
Beck Depression Inventory-II (BDI-II)
To evaluate depression. Scores ranges from 0-63 with higher scores indicating more severe depressive symptoms
Measured: At the first test day
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating scale (MDS-UPDRS) III
A motor examination done by an educated assessor. Scores ranges from 0-132 with higher scores indicating more severe motor disability.
Measured: At the first test day
6-minute walk test (6MWT)
To measure the distance, the participant is able to walk over 6 minutes using a 30 meter track.
Measured: At the first test day
Timed up and go (TUG)
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
Measured: At the first test day
The Montreal Cognitive Assessment (MoCA)
Participants have to complete different task using the MoCA.
Measured: At the first test day
Weight (kg)
We would collect information about weight using bioimpedance sensor (TANITA SC220).
Measured: Four times (one at each visit) during af 40 days period
Blood pressure (systolic/diastolic) (mmHg)
Using a blood pressure monitor to ensure that participants do not have a blood pressure above 160/110 mmHg at test day.
Measured: Four times (one at each visit) during af 40 days period
Date of diagnosis (month and year)
Collecting information from when participants were diagnosed with Parkinson disease to detect disease duration (years)
Measured: At first visit only
Medication
We want to know what type of medication that they use to ensure that participants fulfill the inclusion criterion
Measured: At first visit only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Oct 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127031
- Sponsor's protocol ID
- RHP21
- Status last verified
- Oct 2021
- First submitted
- 27 Oct 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of VO2-max Measurements in Persons With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05127031
- Acronym / sponsor ID
- RHP21
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 19 Nov 2021 (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.
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 design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- Age ≥ 40 year
- Written informed consent
- Diagnosed with idiopathic Parkinson's disease
- Hoehn \& Yahr ≤ 3
- Taking dopaminergic medication
Key exclusion criteria (5 listed)
- Dementia
- Alcohol abuse
- Pacemaker
- Serious cardiovascular, respiratory, orthopedic or other comorbidities excluding maximal exercise participation.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VO2max (O2ml/min/kg) change
Time frame: Up to 40 days
The maximal oxygen consumption during and graded exercise test. Used to asses the day to day variation between two test.
VO2 plateau (Primary validity criterion)
Time frame: Up to 40 days
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.
Respiratory exchange ratio (RER) (secondary validity criterion)
Time frame: Up to 40 days
The ratio between VCO2 (L/min) and VO2 (L/min)
Blood lactate (secondary validity criterion)
Time frame: Up to 40 days
Blood lactate level taken from a fingertip one minute after the VO2max has ended.
Maximal heart rate (beats/min) (secondary validity criterion)
Time frame: Up to 40 days
We would detect the maximal heart rate at the end of the test
Rating perceived exertion (RPE) (secondary validity criterion)
Time frame: Up to 40 days
Using the Borg scala, we would determine the RPE at the end of the test.
11 secondary outcomes
Chair rise - maximal power output (W) change
Time frame: Up to 40 days
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: At the first test day
Beck Depression Inventory-II (BDI-II)
Time frame: At the first test day
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating scale (MDS-UPDRS) III
Time frame: At the first test day
6-minute walk test (6MWT)
Time frame: At the first test day
Timed up and go (TUG)
Time frame: At the first test day
The Montreal Cognitive Assessment (MoCA)
Time frame: At the first test day
Weight (kg)
Time frame: Four times (one at each visit) during af 40 days period
Blood pressure (systolic/diastolic) (mmHg)
Time frame: Four times (one at each visit) during af 40 days period
Date of diagnosis (month and year)
Time frame: At first visit only
Medication
Time frame: At first visit only
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 21 Feb 2023.
- Individual participant dataSharing planned: No
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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?
An observational study of Parkinson Disease, run by University of Aarhus at 1 site in Denmark.
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 6 inclusion and 5 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 21 Feb 2023. 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 Denmark. 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?
VO2max (O2ml/min/kg) change (time frame: Up to 40 days). The study lists 6 primary outcomes in all. 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 21 Feb 2023.