Clinical trial NCT05127031: Validity and Reliability of VO2-max Measurements in Persons With Parkinson's Disease
Official title: Validity and Reliability of VO2-max Measurements in Persons With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
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).

Brief 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.). 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.


Eligibility criteria: 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

Primary outcomes:
measure: VO2max (O2ml/min/kg) change
timeFrame: Up to 40 days
measure: VO2 plateau (Primary validity criterion)
timeFrame: Up to 40 days
measure: Respiratory exchange ratio (RER) (secondary validity criterion)
timeFrame: Up to 40 days
measure: Blood lactate (secondary validity criterion)
timeFrame: Up to 40 days
measure: Maximal heart rate (beats/min) (secondary validity criterion)
timeFrame: Up to 40 days
measure: Rating perceived exertion (RPE) (secondary validity criterion)
timeFrame: Up to 40 days
Secondary outcomes:
measure: Chair rise - maximal power output (W) change
timeFrame: Up to 40 days
measure: Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: At the first test day
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: At the first test day
measure: Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating scale (MDS-UPDRS) III
timeFrame: At the first test day
measure: 6-minute walk test (6MWT)
timeFrame: At the first test day
measure: Timed up and go (TUG)
timeFrame: At the first test day
measure: The Montreal Cognitive Assessment (MoCA)
timeFrame: At the first test day
measure: Weight (kg)
timeFrame: Four times (one at each visit) during af 40 days period
measure: Blood pressure (systolic/diastolic) (mmHg)
timeFrame: Four times (one at each visit) during af 40 days period
measure: Date of diagnosis (month and year)
timeFrame: At first visit only
measure: Medication
timeFrame: At first visit only
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Sport Science, Department of Public Health, Aarhus University
Study officials:
References: