search
Back to results

Moderate Versus High Volume Light-Moderate Intensity Exercise for People With Moderate Parkinson's Disease (HI-LITE)

Primary Purpose

Parkinson Disease, Movement Disorders, Neurodegeneration

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HV-PDAE: High Volume Partnered Dance Aerobic Exercise
MV-PDAE: Moderate Volume Partnered Dance Aerobic Exercise
MV-WALK: Moderate Volume Walking
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring dance, walk, Neurodegenerative, aging, exercise, high volume, frequency, intensity, duration, biomarkers, Parkinson's disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants recruited for this study will be age 40 and older with diagnosis of "definite" PD based upon established criteria (Hughes, Daniel et al. 1992) and determined by a board-certified neurologist with specialty training in movement disorders. Individuals must have presented with asymmetric symptoms that included at least 3 of the cardinal signs of PD (rigidity, bradykinesia, tremor, postural instability), and must show clear symptomatic benefit (e.g., alleviated rigidity, bradykinesia, and tremor) from antiparkinsonian medications, e.g., levodopa (Kempster, Williams et al. 2007). They should be in H&Y stages 2, 2.5 and 3, and receive a Montreal Cognitive Assessment (MoCA) score >17 (Litvan, Goldman et al. 2012). Age 40 is the upper limit for young onset PD. We will not recruit individuals with a history of significant alcohol or drug use, nor habitual users of antipsychotics. We will observe patients while OFF their antiparkinsonian medications to avoid dyskinesia, and medication fluctuations that may impact neurophysiology and motor examination. We have successfully observed patients while OFF in several previous trials. The following inclusion criteria apply: MoCA score >17 Able to walk with or without an assistive device at least 10 feet Best corrected/aided acuity better than 20/70 in the better eye Willingness to be randomized to a treatment group H&Y stages 2, 2.5 and 3 Show clear symptomatic benefit (e.g., alleviated rigidity, bradykinesia, and tremor) from antiparkinsonian medications Fluent in English to be able to comprehend and participate; older than 40 years; Diagnosis of definite Parkinson's disease by board certified Movement Disorders Neurologist, using standardized UK Brain Bank criteria Exclusion Criteria: Participants recruited for this study will be age 40 and older with diagnosis of "definite" PD based upon established criteria (Hughes, Daniel et al. 1992) and determined by a board-certified neurologist with specialty training in movement disorders. Individuals must have presented with asymmetric symptoms that included at least 3 of the cardinal signs of PD (rigidity, bradykinesia, tremor, postural instability), and must show clear symptomatic benefit (e.g., alleviated rigidity, bradykinesia, and tremor) from antiparkinsonian medications, e.g., levodopa (Kempster, Williams et al. 2007). They should be in H&Y stages 2, 2.5 and 3, and receive a Montreal Cognitive Assessment (MoCA) score >17 (Litvan, Goldman et al. 2012). Age 40 is the upper limit for young onset PD. We will not recruit individuals with a history of significant alcohol or drug use, nor habitual users of antipsychotics. The following exclusion criteria apply: Untreated Major Depression and major psychiatric illness History of stroke, or traumatic brain injury Pure-tone threshold average sensitivity at 0.5, 1.0,and 2.0 kHz exceeds 40 dB Alcohol abuse and/or use of antipsychotics Planning to leave the area for >1 month during the study time period. Taking moderate to high doses of beta-blockers with a resting heart rate below 60 beats/min given that exercise intensity is measured through target heart rate. Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention, e.g. renal failure on hemodialysis, excessive alcohol use (>14 drinks per wk)

Sites / Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

HV-PDAE: High Volume Partnered Dance Aerobic Exercise

MV-PDAE: Moderate Volume Partnered Dance Aerobic Exercise

MV-WALK: Moderate Volume Walking

Arm Description

HV-PDAE classes will meet 5 times a week for 90 minute sessions for 3 weeks at onset of trial and then every 4 weeks for a year. All participants will receive 112.5h of training. PDAE was adapted for older adults with balance impairments; modifications were made to the frame and steps of Argentine tango. People with PD partner an individual without PD, e.g., staff, caregiver, friend, or university student. The instructor, staff lead and assistants monitor participants for safety. Class sizes will consist of 6 or fewer pairs of participants with PD and partners. Participants with PD will dance with new partners (individuals without PD) every 15-20 minutes. Participants will learn new steps in each class. The class format includes practicing steps, warm-up, partnering and rhythmic exercises, learning new steps, combining old and new steps, cool down. PDAE classes follow a syllabus with new steps, rhythms and embellishments included in each class.

MV-PDAE: MV classes will meet biweekly for 52 weeks for 65-minute sessions. All participants will receive 112.5h of training. . PDAE was adapted for older adults with balance impairments; modifications were made to the frame and steps of Argentine tango. People with PD partner an individual without PD, e.g., staff, caregiver, friend, or university student. The instructor, staff lead and assistants monitor participants for safety. Class sizes will consist of 6 or fewer pairs of participants with PD and partners. Participants with PD will dance with new partners (individuals without PD) every 15-20 minutes. Participants will learn new steps in each class. The class format includes practicing steps, warm-up, partnering and rhythmic exercises, learning new steps, combining old and new steps, cool down. PDAE classes follow a syllabus with new steps, rhythms and embellishments included in each class.

MV-WALK (65-minute sessions): WALK will control for the walking that participants in PDAE do and will also take place in groups to control social effects of intervention. Walking for exercise expends 3 METS, like PDAE. (Knaggs et al., 2011) 65 minute sessions will consist of 15 minutes of warmup exercises, 45 minutes of walking with breaks ad libitum, and a 5-minute cool down. Setting will be a designated, safe, non-cluttered area for walking- indoors or outdoors. This protocol is in line with recommendations for gait training to improve gait parameters, i.e., 2-3 days per week, for 30-60 minutes and with evidence that light-moderate intensity walking programs can lead to gains in gait parameters.

Outcomes

Primary Outcome Measures

Gait cadence
Gait Cadence is the number of human steps taken per minute.
physical activity measured by the physical activity scale for the elderly (PASE)
This questionnaire is very comprehensive and assesses an older adults' activity level within the previous week by totaling their involvement in a variety of physical activities.
vascular function: Pulse wave velocity and Aortic index
Pulse wave velocity and augmentation aortic index are valid and reliable measures of vascular function. Pulse-wave velocity (PWV) is a measurement of arterial stiffness and is an independent predictor of cardiovascular risk. It can be assessed simply and noninvasively by measuring the carotid and femoral pulse pressures and the time delay between the two or by other methods relying on pulse-wave analysis.

Secondary Outcome Measures

inflammatory cytokine expression: Brain derived neurotrophic factor and c-reactive protein
BDNF: This neurotrophic factor plays an important role in neuronal survival and growth, serves as a neurotransmitter modulator, and participates in neuronal plasticity, which is essential for learning and memory. Other studies have shown it increased in expression after structured long term exercise in populations with neurodegenerative disease. CRP: C reactive protein is a protein made by the liver. The level of CRP increases with inflammation in the body. Some studies have shown decreased levels of CRP in patients who underwent exercise.
VO2 max- maximum oxygen consumption
Vo2 max is the maximal amount of oxygen that someone can use during intense or maximal exercise. It is a good indicator of cardiovascular fitness and aerobic endurane.
inflammatory cytokine expression: and c reactive protein
These are both blood biomarkers derived from serum. Inflammatory cytokine expression: An inflammatory cytokine is a type of cytokine (a signaling molecule) that is secreted from immune cells and certain other cell types that promotes inflammation. Inflammatory cytokines are predominantly produced by T helper cells (Th) and macrophages and involved in the upregulation of inflammatory reactions. CRP: C reactive protein is a protein made by the liver. The level of CRP increases with inflammation in the body. Some studies have shown decreased levels of CRP in patients who underwent exercise.
Six minute walk test and gait speed
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
gait speed (m/s)
Preferred and fast as possible gait speed will be measured with motion capture (APDM opals) over a 20 foot path.

Full Information

First Posted
October 10, 2023
Last Updated
October 12, 2023
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT06088355
Brief Title
Moderate Versus High Volume Light-Moderate Intensity Exercise for People With Moderate Parkinson's Disease
Acronym
HI-LITE
Official Title
Moderate Versus High Volume Light-Moderate Intensity Exercise for People With Moderate Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2024 (Anticipated)
Primary Completion Date
June 1, 2027 (Anticipated)
Study Completion Date
September 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Veterans with mid to later stage Parkinson's disease (PD) may not be able to work out as hard as they need to, to prevent brain cell loss. Maybe they could work out longer and more frequently to make up for this during their good times and good weeks and then rest during the bad weeks. We will compare how effective working out a lot one week per month with a break of three weeks is to continuously exercising weekly with no breaks in people with mid stage PD. We will look at how fast they walk per minute, whether they become more physically active, the biochemicals in their blood, and at how stiff their blood vessels are before and after the exercise.
Detailed Description
For the first time, this project will define the impact of high volume (HV) exercise compared to moderate volume (MV) exercise for Veterans with moderate PD (Stages 2-3). Volume of aerobic exercise (AE) has not been previously well studied in PD, in moderate PD, nor in Veterans. Exercise is now prescribed as a first line therapy in PD. Exact combinations of frequency, duration (the product of which is volume) and intensity of AE need to be determined for optimal delivery of exercise for PD. In contrast to studies of high intensity exercise, which is being investigated in a major stage 3 clinical trial, SPARX3, few studies have examined the impact of volume, in particular HV in PD. As such, AE volume is primed for evaluation, for its effects on gait measures, and overall physical activity (PA). Like (SPARX3), evaluation of volume must include clinically-relevant behavioral measures, e.g., gait parameters, and disease severity; biomarkers of neurodegeneration, representing inflammatory, and neurotrophic mechanisms. Given the strong impact of PD on autonomic and sympathetic processes in PD (Sabino-Carvalho et al., 2020) cardiovascular and vascular processes should also be evaluated- particularly in moderate PD who have OFF-time and greater motor dysfunction. Our published work shows HV light-moderate intensity Partnered dance AE (PDAE) (5 days/week, for 2-3 weeks) - improved gait, motor function and neuromuscular control in people with moderate PD. These functional changes were comparable to changes seen in programs of longer duration and lower weekly volume. PDAE has been tailored for Veterans with PD since 2011 and is adaptable for MV or HV. This project explores effects of exercise dosing that make good use of patients' high functioning times and will lead to enhance gait parameters and more PA. The primary outcome measure is preferred gait cadence, a clinically relevant variable for gait training studies, and which our data show is strongly associated with PA. At the Atlanta VA, for 13 years, Dr. Hackney (PI) and her team have developed a research infrastructure to investigate rehab treatments for Veterans with PD -most of whom have moderate stage PD. The expertise, resources and infrastructure the team has accumulated are crucial for the proposed work. This RCT assigns n=102 (34 per group) older Veterans with PD to 52 weeks of PDAE at HV or moderate volume (MV) or to a MV control (MVWALK). Overall exercise dose will be 112.5 hours over 52 weeks. MV-PDAE and MV-WALK classes will meet twice-weekly for 65-minutes. HV PDAE classes will meet 5 times a week for 90 minutes for three weeks at trial onset followed by one HV week every 4 weeks for a year. Gait cadence will be measured with inertial sensors. PA will be measured with accelerometry and a questionnaire. Outcomes will be assessed at baseline (before intervention), and at 52 weeks (intervention end). We assume 20% attrition and will recruit 21 additional participants, totaling 123 Veteran participants (41 per group). Aim 1 will compare the impact of AE volume on gait cadence and PA. Aim 2 will compare the impact of AE volume on blood biomarkers: IL-7, BDNF and CRP. Aim 3 will compare the impact of exercise volume on vascular function and aerobic capacity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Movement Disorders, Neurodegeneration
Keywords
dance, walk, Neurodegenerative, aging, exercise, high volume, frequency, intensity, duration, biomarkers, Parkinson's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This RCT assigns n=102 (34 per group) older Veterans with PD to 52 weeks of PDAE at HV or moderate volume (MV) or to MV control (MV-WALK). Overall exercise dose will be 112.5 hours over 52 weeks. MV-PDAE and MV-WALK classes will meet twice-weekly for 65-minutes. HV PDAE classes will meet 5 times a week for 90 minutes for three weeks at trial onset followed by one HV week every 4 weeks for a year.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Participants will not be aware if their treatment is experimental or control. With behavioral interventions, it is however, challenging to mask what the actual treatment is.
Allocation
Randomized
Enrollment
123 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HV-PDAE: High Volume Partnered Dance Aerobic Exercise
Arm Type
Experimental
Arm Description
HV-PDAE classes will meet 5 times a week for 90 minute sessions for 3 weeks at onset of trial and then every 4 weeks for a year. All participants will receive 112.5h of training. PDAE was adapted for older adults with balance impairments; modifications were made to the frame and steps of Argentine tango. People with PD partner an individual without PD, e.g., staff, caregiver, friend, or university student. The instructor, staff lead and assistants monitor participants for safety. Class sizes will consist of 6 or fewer pairs of participants with PD and partners. Participants with PD will dance with new partners (individuals without PD) every 15-20 minutes. Participants will learn new steps in each class. The class format includes practicing steps, warm-up, partnering and rhythmic exercises, learning new steps, combining old and new steps, cool down. PDAE classes follow a syllabus with new steps, rhythms and embellishments included in each class.
Arm Title
MV-PDAE: Moderate Volume Partnered Dance Aerobic Exercise
Arm Type
Active Comparator
Arm Description
MV-PDAE: MV classes will meet biweekly for 52 weeks for 65-minute sessions. All participants will receive 112.5h of training. . PDAE was adapted for older adults with balance impairments; modifications were made to the frame and steps of Argentine tango. People with PD partner an individual without PD, e.g., staff, caregiver, friend, or university student. The instructor, staff lead and assistants monitor participants for safety. Class sizes will consist of 6 or fewer pairs of participants with PD and partners. Participants with PD will dance with new partners (individuals without PD) every 15-20 minutes. Participants will learn new steps in each class. The class format includes practicing steps, warm-up, partnering and rhythmic exercises, learning new steps, combining old and new steps, cool down. PDAE classes follow a syllabus with new steps, rhythms and embellishments included in each class.
Arm Title
MV-WALK: Moderate Volume Walking
Arm Type
Active Comparator
Arm Description
MV-WALK (65-minute sessions): WALK will control for the walking that participants in PDAE do and will also take place in groups to control social effects of intervention. Walking for exercise expends 3 METS, like PDAE. (Knaggs et al., 2011) 65 minute sessions will consist of 15 minutes of warmup exercises, 45 minutes of walking with breaks ad libitum, and a 5-minute cool down. Setting will be a designated, safe, non-cluttered area for walking- indoors or outdoors. This protocol is in line with recommendations for gait training to improve gait parameters, i.e., 2-3 days per week, for 30-60 minutes and with evidence that light-moderate intensity walking programs can lead to gains in gait parameters.
Intervention Type
Behavioral
Intervention Name(s)
HV-PDAE: High Volume Partnered Dance Aerobic Exercise
Intervention Description
HV-PDAE classes will meet 5 times a week for 90 minute sessions for 3 weeks at onset of trial and then every 4 weeks for a year. All participants will receive 112.5h of training. PDAE was adapted for older adults with balance impairments; modifications were made to the frame and steps of Argentine tango. People with PD partner an individual without PD, e.g., staff, caregiver, friend, or university student. The instructor, staff lead and assistants monitor participants for safety. Class sizes will consist of 6 or fewer pairs of participants with PD and partners. Participants with PD will dance with new partners (individuals without PD) every 15-20 minutes. Participants will learn new steps in each class. The class format includes practicing steps, warm-up, partnering and rhythmic exercises, learning new steps, combining old and new steps, cool down. PDAE classes follow a syllabus with new steps, rhythms and embellishments included in each class.
Intervention Type
Behavioral
Intervention Name(s)
MV-PDAE: Moderate Volume Partnered Dance Aerobic Exercise
Intervention Description
MV-PDAE: MV classes will meet biweekly for 52 weeks for 65-minute sessions. All participants will receive 112.5h of training. . PDAE was adapted for older adults with balance impairments; modifications were made to the frame and steps of Argentine tango. People with PD partner an individual without PD, e.g., staff, caregiver, friend, or university student. The instructor, staff lead and assistants monitor participants for safety. Class sizes will consist of 6 or fewer pairs of participants with PD and partners. Participants with PD will dance with new partners (individuals without PD) every 15-20 minutes. Participants will learn new steps in each class. The class format includes practicing steps, warm-up, partnering and rhythmic exercises, learning new steps, combining old and new steps, cool down. PDAE classes follow a syllabus with new steps, rhythms and embellishments included in each class.
Intervention Type
Behavioral
Intervention Name(s)
MV-WALK: Moderate Volume Walking
Intervention Description
MV-WALK (65-minute sessions): WALK will control for the walking that participants in PDAE do and will also take place in groups to control social effects of intervention. Walking for
Primary Outcome Measure Information:
Title
Gait cadence
Description
Gait Cadence is the number of human steps taken per minute.
Time Frame
52 weeks
Title
physical activity measured by the physical activity scale for the elderly (PASE)
Description
This questionnaire is very comprehensive and assesses an older adults' activity level within the previous week by totaling their involvement in a variety of physical activities.
Time Frame
52 weeks
Title
vascular function: Pulse wave velocity and Aortic index
Description
Pulse wave velocity and augmentation aortic index are valid and reliable measures of vascular function. Pulse-wave velocity (PWV) is a measurement of arterial stiffness and is an independent predictor of cardiovascular risk. It can be assessed simply and noninvasively by measuring the carotid and femoral pulse pressures and the time delay between the two or by other methods relying on pulse-wave analysis.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
inflammatory cytokine expression: Brain derived neurotrophic factor and c-reactive protein
Description
BDNF: This neurotrophic factor plays an important role in neuronal survival and growth, serves as a neurotransmitter modulator, and participates in neuronal plasticity, which is essential for learning and memory. Other studies have shown it increased in expression after structured long term exercise in populations with neurodegenerative disease. CRP: C reactive protein is a protein made by the liver. The level of CRP increases with inflammation in the body. Some studies have shown decreased levels of CRP in patients who underwent exercise.
Time Frame
52 weeks
Title
VO2 max- maximum oxygen consumption
Description
Vo2 max is the maximal amount of oxygen that someone can use during intense or maximal exercise. It is a good indicator of cardiovascular fitness and aerobic endurane.
Time Frame
52 weeks
Title
inflammatory cytokine expression: and c reactive protein
Description
These are both blood biomarkers derived from serum. Inflammatory cytokine expression: An inflammatory cytokine is a type of cytokine (a signaling molecule) that is secreted from immune cells and certain other cell types that promotes inflammation. Inflammatory cytokines are predominantly produced by T helper cells (Th) and macrophages and involved in the upregulation of inflammatory reactions. CRP: C reactive protein is a protein made by the liver. The level of CRP increases with inflammation in the body. Some studies have shown decreased levels of CRP in patients who underwent exercise.
Time Frame
52 weeks
Title
Six minute walk test and gait speed
Description
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Time Frame
52 weeks
Title
gait speed (m/s)
Description
Preferred and fast as possible gait speed will be measured with motion capture (APDM opals) over a 20 foot path.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants recruited for this study will be age 40 and older with diagnosis of "definite" PD based upon established criteria (Hughes, Daniel et al. 1992) and determined by a board-certified neurologist with specialty training in movement disorders. Individuals must have presented with asymmetric symptoms that included at least 3 of the cardinal signs of PD (rigidity, bradykinesia, tremor, postural instability), and must show clear symptomatic benefit (e.g., alleviated rigidity, bradykinesia, and tremor) from antiparkinsonian medications, e.g., levodopa (Kempster, Williams et al. 2007). They should be in H&Y stages 2, 2.5 and 3, and receive a Montreal Cognitive Assessment (MoCA) score >17 (Litvan, Goldman et al. 2012). Age 40 is the upper limit for young onset PD. We will not recruit individuals with a history of significant alcohol or drug use, nor habitual users of antipsychotics. We will observe patients while OFF their antiparkinsonian medications to avoid dyskinesia, and medication fluctuations that may impact neurophysiology and motor examination. We have successfully observed patients while OFF in several previous trials. The following inclusion criteria apply: MoCA score >17 Able to walk with or without an assistive device at least 10 feet Best corrected/aided acuity better than 20/70 in the better eye Willingness to be randomized to a treatment group H&Y stages 2, 2.5 and 3 Show clear symptomatic benefit (e.g., alleviated rigidity, bradykinesia, and tremor) from antiparkinsonian medications Fluent in English to be able to comprehend and participate; older than 40 years; Diagnosis of definite Parkinson's disease by board certified Movement Disorders Neurologist, using standardized UK Brain Bank criteria Exclusion Criteria: Participants recruited for this study will be age 40 and older with diagnosis of "definite" PD based upon established criteria (Hughes, Daniel et al. 1992) and determined by a board-certified neurologist with specialty training in movement disorders. Individuals must have presented with asymmetric symptoms that included at least 3 of the cardinal signs of PD (rigidity, bradykinesia, tremor, postural instability), and must show clear symptomatic benefit (e.g., alleviated rigidity, bradykinesia, and tremor) from antiparkinsonian medications, e.g., levodopa (Kempster, Williams et al. 2007). They should be in H&Y stages 2, 2.5 and 3, and receive a Montreal Cognitive Assessment (MoCA) score >17 (Litvan, Goldman et al. 2012). Age 40 is the upper limit for young onset PD. We will not recruit individuals with a history of significant alcohol or drug use, nor habitual users of antipsychotics. The following exclusion criteria apply: Untreated Major Depression and major psychiatric illness History of stroke, or traumatic brain injury Pure-tone threshold average sensitivity at 0.5, 1.0,and 2.0 kHz exceeds 40 dB Alcohol abuse and/or use of antipsychotics Planning to leave the area for >1 month during the study time period. Taking moderate to high doses of beta-blockers with a resting heart rate below 60 beats/min given that exercise intensity is measured through target heart rate. Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention, e.g. renal failure on hemodialysis, excessive alcohol use (>14 drinks per wk)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madeleine E Hackney, PhD
Phone
(404) 321-6111
Ext
5006
Email
mehackn@emory.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joe R Nocera, PhD
Phone
(404) 321-6111
Ext
6354
Email
joenocera@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madeleine E. Hackney, PhD
Organizational Affiliation
Atlanta VA Medical and Rehab Center, Decatur, GA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical and Rehab Center, Decatur, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033-4004
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Calas
Phone
404-321-6111
Ext
206795
Email
lisa.calas@va.gov
First Name & Middle Initial & Last Name & Degree
Erica W Watkins, BA
Phone
(404) 321-6111
Ext
5830
Email
erica.watkins@va.gov
First Name & Middle Initial & Last Name & Degree
Madeleine E. Hackney, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Moderate Versus High Volume Light-Moderate Intensity Exercise for People With Moderate Parkinson's Disease

We'll reach out to this number within 24 hrs