What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease include levodopa, dopamine agonists, MAO B inhibitors, and exercise interventions. Levodopa can cause nausea, somnolence, dizziness, headache, and more serious complications like dyskinesia and motor fluctuations. Dopamine agonists may lead to side effects such as orthostatic hypotension, impulse control disorders, and hallucinations. MAO B inhibitors generally have milder side effects but can include insomnia and gastrointestinal issues. Exercise interventions, like the TURN-IT program, are generally safe and can improve motor symptoms and sleep quality, though they may require careful monitoring to avoid overexertion.

What prior FDA approvals exist?

While the FDA has approved various pharmacologic treatments for Parkinson's Disease, such as levodopa, dopamine agonists (e.g., pramipexole, ropinirole), and MAO-B inhibitors, there is limited specific information on FDA approvals for exercise programs like TURN-IT. However, exercise and physical therapy are widely recognized as beneficial for managing Parkinson's Disease symptoms, improving mobility, and enhancing quality of life. Programs focusing on targeted exercises to address physiological constraints, such as those in TURN-IT, are supported by clinical evidence but do not require FDA approval as they are non-pharmacologic interventions.

What other types of research exist?

Promising alternatives to the TURN-IT program for Parkinson's Disease patients include: 1) Specific exercise training and turning-based treadmill training, which have shown effectiveness in improving turning performance by enhancing sensory organization and ankle plantar flexor strength. 2) Cognitive-cycling dual-task training, which may improve both motor and cognitive functions. 3) Rock Steady Boxing, a non-contact boxing-based fitness program that has been beneficial for overall motor function and quality of life in PD patients.

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Exercise Program for Parkinson's Disease

N/A

Recruiting

Led By Fay Horak, PhD, PT

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of idiopathic PD from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia with 1 or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions

Hoehn & Yahr stages II-IV

Must not have

Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD

MoCA ≤ 21 or inability to follow directions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests TURN-IT, an exercise program for people with Parkinson's Disease who have had falls. The program aims to improve turning ability by addressing stiffness, balance, movement speed, and changing movements.

Who is the study for?

This trial is for people aged 55-85 with Parkinson's Disease who have fallen in the past year. They must respond to levodopa treatment, be at certain stages of the disease, and can't have other major health issues or recent medication changes. Participants need to commit to attending exercise sessions without altering their medications or exercise habits.

What is being tested?

The TURN-IT program focuses on improving turning movements in those with Parkinson's by addressing common physical limitations caused by the disease. The study will compare a group doing this special exercise three times a week for six weeks against a control group that does not receive any intervention.

What are the potential side effects?

Since TURN-IT is an exercise program, potential side effects may include muscle soreness, fatigue, and increased risk of falls during practice. However, these are typical responses to physical activity and should be temporary as participants adapt.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Parkinson's diagnosed by a specialist, with symptoms like slow movement, tremor, stiffness, or balance issues not caused by other conditions.

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My Parkinson's disease is at a moderate to advanced stage.

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I am between 55 and 85 years old.

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I have fallen at least once in the last year.

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My condition improves with levodopa treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have major musculoskeletal, neurological disorders, or epilepsy, except for Parkinson's Disease.

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I may have difficulty understanding or following instructions.

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I cannot stand or walk for 2 minutes without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in variability in number of steps to complete a turn

Secondary study objectives

Change in Falls Efficacy Scale International

Change in lateral trunk range

Change in number of steps to complete a turn

+7 more

Other study objectives

Change in Activities-Specific Balance Confidence Scale

Change in Parkinson's Disease Questionnaire-39

Change in Unified Parkinson's Disease Rating Scale, Part III

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TURN-IT groupExperimental Treatment1 Intervention

Participants in the treatment group will attend supervised, 1-hour classes, 3 times per week for 6 weeks, one-on-one with the same exercise trainer, overseen by a physical therapist investigator.

Group II: No Intervention Control GroupActive Control1 Intervention

Participants in this group will be tested at baseline and 6 weeks later. They will go about their normal daily life during the 6 week period.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Parkinson's Disease (PD) include dopaminergic therapies, such as levodopa and dopamine agonists, which work by replenishing or mimicking dopamine to improve motor function. MAO B inhibitors help to prolong the effect of dopamine by inhibiting its breakdown. Nonpharmacologic treatments, particularly exercise programs like TURN-IT, focus on improving motor symptoms by addressing physiological constraints such as axial rigidity, bradykinesia, and balance issues. These exercise interventions are crucial as they can enhance mobility, reduce fall risk, and improve overall quality of life for PD patients by promoting neuroplasticity and physical conditioning.

Dance for Parkinson's-The effects on whole body co-ordination during turning around.