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临床试验/NCT03156400
NCT03156400已完成不适用

Assessment of Autonomic Function and Cardiovascular Response to Exercise Testing in Parkinson's Disease Patients

University of Miami2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Vascular Resistance using ergospirometry

研究概览

简要总结

This study will compare examine autonomic and cardiovascular responses to peak exercise testing in Parkinson's disease patients in varying stages of the disease, and healthy, age-matched participants. Participants will be asked to complete a peak exercise test on a motorized treadmill. Heart rate, blood pressure, norepinephrine, and other markers for cardiovascular function will be assessed at rest, during exercise, and post-exercise. The hypothesis to be tested is that Parkinson's disease patients will exhibit a decreased autonomic and cardiovascular response to exercise when compared to patients' healthy age-matched counterparts. The investigators secondary hypothesis is that Parkinson's disease patients in more advanced stages will exhibit a greater decrease in response when compared to these patients' Stage 1 counterparts, or healthy age-matched counterparts.

详细描述

This study will require the PD subjects to attend three testing days, lasting approximately 1 hour. PD subjects will report for two exercise testing sessions, with each session separated by 7 days. The age-matched, healthy subjects will only be required to attend two testing days consisting of one day for paperwork and anthropometric measurements, and one day for exercise testing, each lasting approximately 1 hour. PD subjects will be randomly assigned, in a counterbalanced manner, to either an "on-medication" or "off-medication" group for days two and three of testing. All subjects with PD will complete both exercise testing days.

Day 1: The subject will read and sign the informed and audio-visual consent forms and complete a health questionnaire, PAR-Q, and mini-mental survey. The subject will also complete the ACSM risk stratification screening questionnaire. Anthropometric measures will be taken to include, waist circumference, height, and weight. The subject will then be introduced to various test procedures which will be utilized throughout the experiment. Each subject will be familiarized with the treadmill and harness support system. The harness support system will be emplaced to ensure the safety of the PD patients due to the inherent fall risk associated with a progressive decline in motor control often seen in this population. The subject will walk on the treadmill at gradually increasing speeds until he or she indicates, by a prearranged signal, that a comfortable walking speed has been attained. Then the treadmill grade will be raised 2% every 30 seconds so the subject can feel what it is like to walk during a progressive test. This will last no longer than five minutes. PD subjects will also be given instruction as to which group (on, or off-medication) they have been assigned to, and how to prepare for the follow-on tests.

Off-Medication Testing Day: Subjects will complete a blood draw and a motorized treadmill VO2peak¬ test. Subjects are expected to arrive fasted (no food or drink for the past 12 hours) and having refrained from antiparkinsonian medication(s) for the past 24 hours. The subject will first be seated and given a 5 minute rest period. Following this rest period the phlebotomist will insert a catheter into the median cephalic vein in the antecubital (bend in the arm) region on the subject's arm. One vial (3 cc) of venous blood will be drawn prior to exercise testing and an identical draw will take place immediately following exercise testing. All blood specimens will be tested and analyzed at the University of Miami Miller School of Medicine. Then subject will then be allowed to eat a predetermined meal at the lab before returning to exercise. Following the meal, the subject will be asked to return to a seated resting position for an additional 5 minute period. During this time, gel electrodes will be applied on the subject for the purposes of ECG and heart/blood flow monitoring and measurements. Following this rest period, blood flow will be measured for an additional 5 minutes while the subject remains quietly seated. Next, the subject will be attached to the harness support system for the treadmill exercise test. For the metabolic assessment portion of the test, the subject will be fitted with a mask covering the nose and mouth, in which an airflow sensor will be attached to measure gas content during respirations. The test will start with a 4 minute warm-up at a speed dictated by the subject. By the end of the warm up, the subject will have reached a speed that both they and instructor agree upon which meets the requirements for moderate-intensity exercise. The speed will no longer be adjusted at this point. Percent grade will start at 2.5 percent and will be increased by 2.5 percent every 3 minutes until the subject has met the criterion for a peak exercise test, or has requested to stop. BP and HR will be monitored every minute of testing using an automatic electronic BP assessment machine (BPTRU, Coquitlam, BC), manual sphygmomanometer and stethoscope, and electronic ECG software (Cardiosoft, GE Healthcare), respectively. Successful completion of the test will be determined using the following criteria from the American College of Sports Medicine (ACSM): (1) plateau in VO2, (2) maximal HR within 10 beats per minute of an age predicted maximum, (3) a respiratory exchange ratio of >1.15, (4) respirations > 50 breaths per minute, (5) a rating of perceived exertion (RPE) ≥ 18. In addition to these criteria we will use ACSM indications for termination of an exercise test which include:

Absolute Indications

  1. Suspicion of a myocardial infarction or acute myocardial infarction (heart attack)
  2. Onset of moderate-to-severe angina (chest pain)
  3. Signs of poor perfusion (circulation or blood flow), including pallor (pale appearance to the skin), cyanosis (bluish discoloration), or cold and clammy skin
  4. Severe or unusual shortness of breath
  5. Central Nervous System (CNS) symptoms e.g., ataxia (failure of muscular coordination), vertigo (an illusion of dizzying movement), visual or gait (pattern of walking or running) problems, confusion
  6. Technical inability to monitor the ECG
  7. Patient's request (to stop) Relative Indications

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women can be included in the study if these potential participants are between 50 and 85 years of age and meet the following criteria:
  • Have received clearance from a primary physician to perform a peak exercise test.
  • Will be able to walk on a motorized treadmill with supporting harness system.
  • Are Individuals with PD having recently had a diagnosis of Stage 1, or 2, or 3 on the Hoehn and Yahr scale and can present the research team with evidence from the potential participant's physician stating the diagnosis.
  • The potential participant is a healthy individual with no unresolved cardiovascular, neuromuscular, and/or musculoskeletal disease.

排除标准

  • Men and women will be excluded from participation if the individual:
  • Has been advised by a physician not to exercise.
  • Is currently participating, or within the past 3 months has participated, in an exercise training program.
  • Is currently on any cardiac or blood pressure medication.
  • Has any additional neurological disorder.
  • Is considered to be at high risk for cardiovascular disease as determined by the - American College of Sports Medicine (ACSM) risk stratification screening questionnaire or their primary physician.
  • Is unable to provide informed consent.
  • has a Mini-mental score less than
  • Is pregnant.
  • Is currently a prisoner.

研究组 & 干预措施

Parkinson's disease

Active Comparator

Men and women can be included in the study if they are between 50 and 85 years of age and meet the following criteria:

Have received clearance from a primary physician to perform a exercise stress test.

Will be able to walk on a motorized treadmill with supporting harness system. Individual with PD who has recently had a diagnosis of Stage 1 or 2 on the Hoehn and Yahr scale.

干预措施: Exercise Stress Test (Other)

Healthy Control

Active Comparator

Men and women can be included in the study if they are between 50 and 85 years of age and meet the following criteria:

Have received clearance from a primary physician to perform a exercise stress test.

Will be able to walk on a motorized treadmill with supporting harness system. Healthy individual with no unresolved cardiovascular, neuromuscular, and/or musculoskeletal disease.

干预措施: Exercise Stress Test (Other)

结局指标

主要结局

Vascular Resistance using ergospirometry

时间窗: 12 minutes

Changes in resistive force during increases in workload using PhysioFlow automated respiratory gas ergospirometer

Blood Pressure Response

时间窗: 12 minute

Blood Pressure responses during increases in workload using automated blood pressure cuff

Cardiac Output using ergospirometry

时间窗: 12 minute

Cardiac responses during increases in workload using PhysioFlow automated respiratory gas ergospirometer

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph Signorile

Professor

University of Miami

研究点 (2)

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