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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to twelve week and change from twelve weeks to 24 weeks.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to twelve weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to twelve weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Cognition in Stroop inhibition
Secondary outcome measures
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.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,594 Previous Clinical Trials
2,282,975 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,977 Previous Clinical Trials
2,680,677 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,749 Previous Clinical Trials
2,163,940 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My medications have been the same for the last 4 weeks and won't change during the study.My cognitive test score is between 18 and 25.I show signs of unusual Parkinson-like symptoms.My Parkinson's disease is at a moderate stage.You have had deep brain stimulation (DBS) treatment.My Parkinson's symptoms were caused by medication, strokes, or head injuries.I need help to walk.I have Parkinson's disease diagnosed with slow movements and possibly tremor, stiffness, or balance issues.People who work night shifts or irregular hours.I do not have serious heart or lung conditions.You participate in an exercise program on a regular basis.I am 45 years old or older.I have sleep apnea that has not been treated.I have been diagnosed with narcolepsy.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise Group
- Group 2: Delayed Exercise Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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