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

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ClinicalTrials.gov Identifier: NCT05127031
Recruitment Status : Recruiting
First Posted : November 19, 2021
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease
Parkinson Disease

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Validity and Reliability of VO2-max Measurements in Persons With Parkinson's Disease
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
A blood lactate test would be completed immediately after the VO2-max test.


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05127031


Contacts
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Contact: Frederik B Jensen +4521268252 201607541@post.au.dk

Locations
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Denmark
Sport Science, Department of Public Health, Aarhus University Recruiting
Aarhus, Denmark, 8000
Contact: Ulrik Dalgas    +4540123039    dalgas@ph.au.dk   
Sponsors and Collaborators
University of Aarhus
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT05127031    
Other Study ID Numbers: RHP21
First Posted: November 19, 2021    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases