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NCT Number: NCT05127031

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sport Science, Department of Public Health, Aarhus University

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. Respiratory exchange ratio (RER) (secondary validity criterion)

    Time frame: Up to 40 days

    The ratio between VCO2 (L/min) and VO2 (L/min)

  4. 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.

  5. 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

  6. 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.

Secondary outcomes

  1. Chair rise - maximal power output (W) change

    Time frame: Up to 40 days

    The maximal power output measured during af chair rise (Linear Encoder). Using the change between two tests to evaluate the reliability

  2. Parkinson's Disease Questionnaire (PDQ-39)

    Time frame: At the first test day

    A questionnaire to evaluate the quality of life with scores ranging from 0-100 (higher scores indicating worse quality of life)

  3. Beck Depression Inventory-II (BDI-II)

    Time frame: At the first test day

    To evaluate depression. Scores ranges from 0-63 with higher scores indicating more severe depressive symptoms

  4. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating scale (MDS-UPDRS) III

    Time frame: At the first test day

    A motor examination done by an educated assessor. Scores ranges from 0-132 with higher scores indicating more severe motor disability.

  5. 6-minute walk test (6MWT)

    Time frame: At the first test day

    To measure the distance, the participant is able to walk over 6 minutes using a 30 meter track.

  6. Timed up and go (TUG)

    Time frame: At the first test day

    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

  7. The Montreal Cognitive Assessment (MoCA)

    Time frame: At the first test day

    Participants have to complete different task using the MoCA.

  8. Weight (kg)

    Time frame: Four times (one at each visit) during af 40 days period

    We would collect information about weight using bioimpedance sensor (TANITA SC220).

  9. Blood pressure (systolic/diastolic) (mmHg)

    Time frame: Four times (one at each visit) during af 40 days period

    Using a blood pressure monitor to ensure that participants do not have a blood pressure above 160/110 mmHg at test day.

  10. Date of diagnosis (month and year)

    Time frame: At first visit only

    Collecting information from when participants were diagnosed with Parkinson disease to detect disease duration (years)

  11. Medication

    Time frame: At first visit only

    We want to know what type of medication that they use to ensure that participants fulfill the inclusion criterion

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2021
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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