Parkinson DiseaseNCT03156400
Parkinson's Autonomic Responses to Treadmill Walking
A study testing Exercise Stress Test in people with Parkinson Disease and Autonomic Dysfunction, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Autonomic Dysfunction
- What is being tested?
- Exercise Stress Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2017to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Or,
- The potential participant is a healthy individual with no unresolved cardiovascular, neuromuscular, and/or musculoskeletal disease.
Who cannot join
- 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.
Show all 10Show fewer
- Is unable to provide informed consent.
- has a Mini-mental score less than 18.
- Is pregnant.
- Is currently a prisoner.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory of Clinical Research
Coral Gables, Florida, 33127
About this study
Official title: Assessment of Autonomic Function and Cardiovascular Response to Exercise Testing in Parkinson's Disease Patients
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.
Read the detailed description
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
- Suspicion of a myocardial infarction or acute myocardial infarction (heart attack)
- Onset of moderate-to-severe angina (chest pain)
- Signs of poor perfusion (circulation or blood flow), including pallor (pale appearance to the skin), cyanosis (bluish discoloration), or cold and clammy skin
- Severe or unusual shortness of breath
- 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
- Technical inability to monitor the ECG
- Patient's request (to stop) Relative Indications
- Any chest pain that is increasing 2. Physical or verbal manifestations of shortness of breath or severe fatigue 3. Wheezing 4. Leg cramps or intermittent claudication (grade 3 on a 4-point scale) 5. Hypertensive response (SBP >260 mm Hg; DBP>115 mm Hg) 6. Pronounced ECG changes from baseline (>2 mm of horizontal or down sloping ST- segment depression, or >2 mm of ST-segment elevation (except in aVR) 7. Exercise-induced bundle branch block that cannot be distinguished from ventricular tachycardia 8. Less serious arrhythmias (abnormal heart rhythms) such as supraventricular tachycardia On-Medication Testing Day: Procedures for the on-medication day will be identical to those used for the off-medication day testing. Each day, following the completion of exercise testing, subjects will be required to remain under lab personnel supervision until HR returns to within 10 beats of resting, and systolic BP returns to within 20 mmHg of resting. HR recovery will be measured continuously following exercise to determine how quickly it returns to baseline. This is a useful measure in determining autonomic function and the progression of PD symptoms.
- Conditions
- Parkinson Disease, Autonomic Dysfunction
- Being tested
- Exercise Stress Test
- Medical subject headings
- Parkinson Disease, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Stress TestOther
Gradual increase in treadmill grade while collecting respiratory gases.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise Stress Test |
| 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. Receives: Other: Exercise Stress Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Response
Blood Pressure responses during increases in workload using automated blood pressure cuff
Measured: 12 minute
Cardiac Output using ergospirometry
Cardiac responses during increases in workload using PhysioFlow automated respiratory gas ergospirometer
Measured: 12 minute
Vascular Resistance using ergospirometry
Changes in resistive force during increases in workload using PhysioFlow automated respiratory gas ergospirometer
Measured: 12 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start15 Feb 2017
- Primary completion26 Mar 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Signorile, University of Miami
- Investigators
- Joseph Signorile, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156400
- Sponsor's protocol ID
- 20160709
- Status last verified
- Jul 2018
- First submitted
- 3 Mar 2017
- Last updated
- 6 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared upon request from specific researchers
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Autonomic Function and Cardiovascular Response to Exercise Testing in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT03156400
- Acronym / sponsor ID
- 20160709
- Conditions
- Parkinson Disease, Autonomic Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Suspicion of a myocardial infarction or acute myocardial infarction (heart attack)
- Onset of moderate-to-severe angina (chest pain)
- Signs of poor perfusion (circulation or blood flow), including pallor (pale appearance to the skin), cyanosis (bluish discoloration), or cold and clammy skin
- Severe or unusual shortness of breath
- 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
- Technical inability to monitor the ECG
- Patient's request (to stop) Relative Indications
- Any chest pain that is increasing 2. Physical or verbal manifestations of shortness of breath or severe fatigue 3. Wheezing 4. Leg cramps or intermittent claudication (grade 3 on a 4-point scale) 5. Hypertensive response (SBP >260 mm Hg; DBP>115 mm Hg) 6. Pronounced ECG changes from baseline (>2 mm of horizontal or down sloping ST- segment depression, or >2 mm of ST-segment elevation (except in aVR) 7. Exercise-induced bundle branch block that cannot be distinguished from ventricular tachycardia 8. Less serious arrhythmias (abnormal heart rhythms) such as supraventricular tachycardia On-Medication Testing Day: Procedures for the on-medication day will be identical to those used for the off-medication day testing. Each day, following the completion of exercise testing, subjects will be required to remain under lab personnel supervision until HR returns to within 10 beats of resting, and systolic BP returns to within 20 mmHg of resting. HR recovery will be measured continuously following exercise to determine how quickly it returns to baseline. This is a useful measure in determining autonomic function and the progression of PD symptoms.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease | Active comparator | Other: Exercise Stress TestMen 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. |
| Healthy Control | Active comparator | Other: Exercise Stress TestMen 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Or,
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Stress TestGradual increase in treadmill grade while collecting respiratory gases. | Other | Healthy Control, Parkinson's disease |
Primary outcome
Blood Pressure Response
Time frame: 12 minute
Blood Pressure responses during increases in workload using automated blood pressure cuff
Cardiac Output using ergospirometry
Time frame: 12 minute
Cardiac responses during increases in workload using PhysioFlow automated respiratory gas ergospirometer
Vascular Resistance using ergospirometry
Time frame: 12 minutes
Changes in resistive force during increases in workload using PhysioFlow automated respiratory gas ergospirometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Individual participant dataSharing planned: No. IPD will be shared upon request from specific researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Signorile, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Stress Test in people with Parkinson Disease and Autonomic Dysfunction, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Response (time frame: 12 minute). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.