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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05127031
• Other study ID #: RHP21
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Denmark	Sport Science, Department of Public Health, Aarhus University	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Respiratory exchange ratio (RER) (secondary validity criterion)	The ratio between VCO2 (L/min) and VO2 (L/min)	Up to 40 days
Primary	Blood lactate (secondary validity criterion)	Blood lactate level taken from a fingertip one minute after the VO2max has ended.	Up to 40 days
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The Montreal Cognitive Assessment (MoCA)	Participants have to complete different task using the MoCA.	At the first test day
Secondary	Weight (kg)	We would collect information about weight using bioimpedance sensor (TANITA SC220).	Four times (one at each visit) during af 40 days period
Secondary	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
Secondary	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
Secondary	Medication	We want to know what type of medication that they use to ensure that participants fulfill the inclusion criterion	At first visit only