Moderate Versus High Volume Light-Moderate Intensity Exercise for People With Moderate Parkinson's Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 13 years, 52 weeks, 3 weeks
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "At the Atlanta VA, for 13 years, Dr."
- "Overall exercise dose will be 112.5 hours over 52 weeks."
- "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."
- "PA will be measured with accelerometry and a questionnaire."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares two light-to-moderate exercise plans for people with mid-stage Parkinson’s disease: more exercise during one week each month, followed by three weeks off, or exercise every week without breaks. Researchers will measure walking speed, physical activity, blood chemicals, and blood vessel stiffness.
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. The investigators 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. The investigators will look at how fast participants 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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 40 or older, though one part of the listing says older than 40.
- Parkinson’s confirmed by a movement disorder specialist, with symptoms worse on one side and at least three signs: stiffness, slow movement, shaking, or balance problems.
- Parkinson’s at stage 2, 2.5, or 3 on the Hoehn and Yahr scale, which measures disease severity.
- Parkinson’s medicines clearly improve symptoms.
- Score above 17 on the MoCA, a test of memory and thinking.
- Able to walk at least 10 feet, with or without a walking aid.
- Vision better than 20/70 in the better eye, using glasses or other vision aids if needed.
- Fluent in English and willing to have the study group chosen by chance.
Who can't join
- Untreated major depression or a major mental illness.
- Past stroke or brain injury caused by trauma.
- Hearing test results averaging above 40 decibels at the listed sound levels.
- History of serious alcohol or drug use, alcohol abuse, more than 14 drinks per week, or use of antipsychotic medicines.
- Plans to leave the area for more than one month during the study.
- Taking medium-to-high doses of beta-blockers, medicines that slow the heart, with a resting heart rate below 60 beats per minute.
- Severe heart disease, including advanced heart failure, major narrowing of the aortic heart valve, past cardiac arrest, an implanted heart shock device, or uncontrolled chest pain.
- Another serious illness that would prevent exercise, such as kidney failure needing dialysis, a treatment that filters the blood.
Simplified for readability. The official criteria below are what the study team uses.
Official 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. The investigators will not recruit individuals with a history of significant alcohol or drug use, nor habitual users of antipsychotics. The investigators will observe patients while OFF their antiparkinsonian medications to avoid dyskinesia, and medication fluctuations that may impact neurophysiology and motor examination. The investigators 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. The investigators 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)
Study sites (1)
GA
- Atlanta VA Medical and Rehab Center, Decatur, GA · Decatur, GA 30033-4004Lisa Calas · Study contact · (404) 321-6111 ext. 206795 · lisa.calas@va.govErica W Watkins, BA · Study contact · (404) 321-6111 ext. 5830 · erica.watkins@va.govMadeleine E. Hackney, PhD · Principal investigatorMore trials in Decatur