Validity and Reliability of VO2-max Measurements in Persons With Parkinson's Disease

Study Overview
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Brief Summary
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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.

Official Title
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Validity and Reliability of VO2-max Measurements in Persons With Parkinson's Disease

Conditions
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Parkinson Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 40 days | 
| Respiratory exchange ratio (RER) (secondary validity criterion) | The ratio between VCO2 (L/min) and VO2 (L/min) | Up to 40 days | 
| Blood lactate (secondary validity criterion) | Blood lactate level taken from a fingertip one minute after the VO2max has ended. | 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 | 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. | Up to 40 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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 | 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. | 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. | 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 | At the first test day | 
| The Montreal Cognitive Assessment (MoCA) | Participants have to complete different task using the MoCA. | At the first test day | 
| Weight (kg) | We would collect information about weight using bioimpedance sensor (TANITA SC220). | 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. | 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) | At first visit only | 
| Medication | We want to know what type of medication that they use to ensure that participants fulfill the inclusion criterion | At first visit only |