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
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|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|
- 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.
- 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
- 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)
- 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
- 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.
- 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.
- 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
- The Montreal Cognitive Assessment (MoCA) [ Time Frame: At the first test day ]Participants have to complete different task using the MoCA.
- 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).
- 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.
- 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)
- 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
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
|Contact: Frederik B Jensenemail@example.com|
|Sport Science, Department of Public Health, Aarhus University||Recruiting|
|Aarhus, Denmark, 8000|
|Contact: Ulrik Dalgas +4540123039 firstname.lastname@example.org|