Aerobic walking for Parkinson Disease

Phase-Based Estimates
1
Effectiveness
2
Safety
Iowa City VA Health Care System, Iowa City, IA, Iowa City, IA
Parkinson Disease+1 More
Aerobic walking - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Parkinson Disease

Study Summary

This study is evaluating whether aerobic exercise may help improve symptoms of Parkinson's disease.

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Eligible Conditions

  • Parkinson Disease
  • Parkinson's Disease (PD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Aerobic walking will improve 6 primary outcomes, 19 secondary outcomes, and 1 other outcome in patients with Parkinson Disease. Measurement will happen over the course of Change from Baseline motor experiences of daily living score at 1 year.

Year 1
Dexterity (time on 9-hole peg board) test of NIH Toolbox motor battery
Year 1
Beck Anxiety Inventory (BAI) score
Year 1
COGSTAT score
Year 1
Radial Diffusivity (rD) on Diffusion imaging tractography
Year 1
Endurance (distance on 6-minute walk) test
Year 1
Fatigue Severity Scale (FSS)
Year 1
Geriatric Depression Scale (GDS) score
Year 1
Locomotion (time on 25-f walk test for gait speed) test
Year 1
Locomotion (time on 4-m walk test for gait speed) test of NIH Toolbox motor battery
Year 1
MDS-UPDRS Non-motor Experiences of Daily Living subscale (Part I) score
Year 1
Mini-Mental Status Examination (MMSE)
Year 1
Montreal Cognitive Assessment (MOCA)
Year 1
OFF period MDS-UPDRS Motor Subscale score
Year 1
ON Period MDS-UPDRS motor examination subscale score
Year 1
Summary index of the Parkinson's Disease Questionnaire-39 (PDQ-39)
Year 1
Parkinson's Disease Sleep Scale version 2 (PDSS-2)
Year 1
Percent Increase Score (PIS) on Eriksen's flanker task
Year 1
VO2max on cycle ergometry
Year 1
Finger Tapping test
Year 1
EEG
Year 1
Motor experiences of daily living score
Year 1
regional DTI (diffusion tensor imaging)
Year 1
Early Treatment Diabetic Retinopathy Study (ETDRS)
Pelli-Robson Contrast Sensitivity
Schwab and England Activities of Daily Living Scale
Year 1
total number of driving safety errors on road test

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Aerobic

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Aerobic Walking is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Aerobic
Behavioral
Participants randomized to aerobic exercise
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline score at 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from baseline score at 1 year for reporting.

Closest Location

Iowa City VA Health Care System, Iowa City, IA - Iowa City, IA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Men or women aged 40 and older with the diagnosis of idiopathic PD per UK Brain Bank criteria
Hoehn-Yahr Stage I-III, on stable dopaminergic treatment regimen for equal or greater than 4 weeks prior to baseline.
Aerobic Fitness: VO2max below "very good" fitness levels for their age and gender at baseline cyle ergometry.
To include subjects who have room to improve their aerobic fitness, the investigators will enroll only those subjects whose VO2max is below "very good" fitness level (about 90% of the population) using age and gender based VO2max norms based review of 62 studies where VO2max was measured directly in healthy adult subjects in the USA, Canada and 7 European countries (Reference: Shvartz, E and Reibold, RC. Aerobic fitness norms for males and females aged 6 to 75 years: a review.
Aviat Space Environ Med. 1990; 61:3-11).
Cognitive function: No dementia per Movement Disorder Society Level I criteria (Reference: Dubois, B, Burn, D, Goetz, C, et al. Diagnostic procedures for Parkinson's disease dementia: recommendations from the movement disorder society task force. Mov Disord. 2007; 22:2314-2324).
Current active drivers with a valid driver's license
Veteran or non-veteran

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get parkinson disease a year in the United States?

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About 1 percent of the population of the United States is affected by Parkinson disease at some point in their life. Patients are at an increased risk for developing dementia with the onset of the disease. As many as 85 percent of patients require some form of care 1 month after diagnosis. If current trends continue, by the year 2100 more than one in every five people in the United States will have Parkinson's disease.

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Can parkinson disease be cured?

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Neurological symptoms of Parkinson's disease are usually not cured in the course of the disease, although improvements can occur in some respects. The only cure for the disease seems to be removal of the disease itself.

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What is parkinson disease?

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Parkinson disease is a neurological disorder characterized by movement problems, such as tremors and muscle rigidity which occur in a cluster. Roughly 1 in 250 people in the USA will develop Parkinson disease during their life.\n

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What are common treatments for parkinson disease?

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Drugs for Parkinson's disease are often not the first choices of treatment. For the majority to treat pain, a non opioid alternative, such as palliative care should be sought.

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What causes parkinson disease?

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Probably there are many causes for PD, many shared among patients; but some factors may differ according to gender or familial history of PD. It appears, however, that the risk factor "older age at onset of PD" is strongly correlated with the severity (fast progression).

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What are the signs of parkinson disease?

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As PD progresses, both symptoms and signs worsen. As the disease progresses, symptoms usually become more severe and more of daily living is affected. The severity of symptoms increases for as long as the disease is present. Although most people with PD remain in their homes after diagnosis, the prevalence of nursing home stays among people with PD is rising and likely to continue to increase. Over one-fifth of people with PD require nursing home care. The signs of advanced PD are progressive and irreversible and include weakness of muscles and limbs, stiff joints, trouble walking, slow speech, and difficulty swallowing.

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What are the latest developments in aerobic walking for therapeutic use?

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A study of more than 2,000 adults with stroke found exercise of any type was associated with a significant improvement in walking performance in the 6-MWT. In children with CP, walking velocity increased to >1,000 meters/min.

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What are the common side effects of aerobic walking?

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Frequent and long-term aerobic walking has a profound effects on the cardiovascular health risks, in particular cardiovascular rehabilitation programs in the primary care should include, besides the physical and lifestyle advice, the prevention of cardiovascular diseases as we do for walking exercise.

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What is the latest research for parkinson disease?

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There is no current research that provides the most up-to-date information about the management and treatment of PD. Patients and clinicians need to be aware of available treatments and evidence in order to make informed decisions. We also need more studies that address PD’s natural history, pathophysiology, and quality of life in this disease.

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Does parkinson disease run in families?

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Parkinsonism appears to run in families. It is not rare for a first-degree relative to have developed the disease. A major part of the variance in disease severity can be attributed to genetic factors.

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Have there been other clinical trials involving aerobic walking?

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Most studies on the topic are limited by small sample size, lack of baseline measures, and short follow-up. The large proportion of nonscientists (and possibly even nonmedical health professionals) in the study samples suggests a need for improved methods related to health professions participation in clinical trials and for more general education of the public as to how to participate in clinical trials.

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Is aerobic walking typically used in combination with any other treatments?

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The use of walking with other treatment modalities is not prevalent. While walking is an integral part of treatment for Parkinson's disease, it is not widely used as a form of treatment in PD in combination with other treatments.

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