Validity and Reliability of VO2-max Measurements in Persons With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- VO2max (O2ml/min/kg) change
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Alcohol abuse
- •Pacemaker
- •Serious cardiovascular, respiratory, orthopedic or other comorbidities excluding maximal exercise participation.
- •Pregnancy
结局指标
主要结局
VO2max (O2ml/min/kg) change
时间窗: 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)
时间窗: 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.
Maximal heart rate (beats/min) (secondary validity criterion)
时间窗: Up to 40 days
We would detect the maximal heart rate at the end of the test
Respiratory exchange ratio (RER) (secondary validity criterion)
时间窗: Up to 40 days
The ratio between VCO2 (L/min) and VO2 (L/min)
Blood lactate (secondary validity criterion)
时间窗: Up to 40 days
Blood lactate level taken from a fingertip one minute after the VO2max has ended.
Rating perceived exertion (RPE) (secondary validity criterion)
时间窗: Up to 40 days
Using the Borg scala, we would determine the RPE at the end of the test.
次要结局
- Parkinson's Disease Questionnaire (PDQ-39)(At the first test day)
- Beck Depression Inventory-II (BDI-II)(At the first test day)
- 6-minute walk test (6MWT)(At the first test day)
- Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating scale (MDS-UPDRS) III(At the first test day)
- The Montreal Cognitive Assessment (MoCA)(At the first test day)
- Weight (kg)(Four times (one at each visit) during af 40 days period)
- Chair rise - maximal power output (W) change(Up to 40 days)
- Blood pressure (systolic/diastolic) (mmHg)(Four times (one at each visit) during af 40 days period)
- Timed up and go (TUG)(At the first test day)
- Medication(At first visit only)
- Date of diagnosis (month and year)(At first visit only)