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Exercise Training for Parkinson's Disease

N/A

Recruiting

Led By Amy Amara, MD, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Montreal Cognitive Assessment (MoCA) score ≥ 18 and <26 (performed at screening visit)

On stable medications for at least 4 weeks prior to study entry without expecting to change medications for the duration of the study

Must not have

Signs indicative of atypical Parkinsonism (cerebellar signs, supranuclear gaze palsy, apraxia, prominent autonomic failure, or other cortical signs)

Secondary Parkinsonism (neuroleptic treatment at time of onset of Parkinsonism or at time of study entry, history of multiple strokes with stepwise progression of Parkinsonism, or history of multiple head injuries)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to twelve week and change from twelve weeks to 24 weeks.

Summary

This trial looks at whether exercise can help improve cognition in people with Parkinson's, and whether slow wave sleep is a marker of how well someone will respond to exercise rehabilitation.

Who is the study for?

This trial is for people aged 45 or older with Parkinson's Disease (PD) who can walk without help and have mild to moderate symptoms. They should be on stable PD meds, not expecting changes during the study, and score between 18-26 on a cognitive test. Those with serious heart conditions, other types of Parkinsonism, deep brain stimulation implants, untreated sleep disorders or those already doing regular exercise cannot join.

What is being tested?

The study tests how different exercise programs—Endurance Training (ET), Delayed Exercise Training (DE), Progressive Resistance Training (PRT)—affect thinking skills in PD patients and if Slow Wave Sleep can indicate improvement from these exercises.

What are the potential side effects?

While specific side effects are not listed for this type of physical activity intervention, general risks may include muscle soreness, fatigue, joint pain or injury. The safety will be monitored closely given the participants' condition.

Eligibility Criteria

Inclusion Criteria

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

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My cognitive test score is between 18 and 25.

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My medications have been the same for the last 4 weeks and won't change during the study.

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My Parkinson's disease is at a moderate stage.

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I have Parkinson's disease diagnosed with slow movements and possibly tremor, stiffness, or balance issues.

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I am 45 years old or older.

Exclusion Criteria

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

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I show signs of unusual Parkinson-like symptoms.

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My Parkinson's symptoms were caused by medication, strokes, or head injuries.

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I need help to walk.

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I do not have serious heart or lung conditions.

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I have sleep apnea that has not been treated.

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I have been diagnosed with narcolepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to twelve weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to twelve weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to twelve 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 Cognition in Stroop inhibition

Secondary study objectives

Change in slow wave sleep (SWS)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Exercise GroupActive Control2 Interventions

PD participants randomized to progressive resistance training PRT) will have 12 weeks of supervised PRT 3 times per week. After the 1st 12 weeks, responders to PRT (increase in slow wave sleep) will continue PRT for an additional 12 weeks, non-responders to PRT will transition to endurance training (ET).

Group II: Delayed Exercise GroupPlacebo Group2 Interventions

PD participants randomized to the delayed exercise control group will not exercise for the 1st 12 weeks of the study. After the 1st 12 weeks, participants in the delayed exercise group will transition to PRT for the 2nd 12 weeks.

0 / 11Eligibility criteria met