RecruitingNot ApplicableNCT04796506

Slow Wave Sleep As a Biomarker of Rehabilitation-induced Cognitive Improvement in PD

Slow Wave Sleep As a Biomarker of Rehabilitation-induced Cognitive Improvement in Parkinson's Disease R01 HD100670

Sponsor

University of Colorado, Denver

Enrollment

120 participants

Start Date

Jul 1, 2021

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

Summary

The purpose of this study is to investigate the effects of exercise rehabilitation on cognition and to evaluate slow wave sleep (SWS) as a biomarker and mediator of response to rehabilitation-induced improvement in cognitive performance among persons with Parkinson's disease (PwP), with the ultimate goal of maximizing rehabilitation efficacy at the individual level (i.e. precision rehabilitation).

Eligibility

Min Age: 45 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether slow wave sleep (deep, restorative sleep) can serve as a marker to predict cognitive improvement from rehabilitation in people with Parkinson's disease (PD). Researchers believe that people who have more slow wave sleep may respond better to cognitive rehabilitation programs. **You may be eligible if...** - You are 45 or older - You have a clinical diagnosis of Parkinson's disease (idiopathic PD) - Your PD is at Hoehn and Yahr stage 2 or 3 (moderate disability) - Your medications have been stable for at least 4 weeks - You have mild cognitive impairment (scoring 18–25 on the Montreal Cognitive Assessment) **You may NOT be eligible if...** - Your PD is in the very early or very advanced stages - Your cognition is either completely normal or severely impaired - Your medications have changed recently - You are under 45 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERProgressive Resistance Training (PRT)

PD subjects may be randomized (1:1) to PRT with supervised sessions 3 times per week for 12 weeks. Exercise training will consist of a combination of resistance training (RT) and bodyweight functional mobility exercises with limited rest intervals. The full volume exercise prescription will consist of: 1) five movements to improve strength and muscle mass each performed for 3 sets of 8-12 repetitions; 2) trunk exercises to improve postural stability; and 3) 3-4 bodyweight exercises to improve power and balance. Change in slow wave sleep (SWS) from baseline to 12-weeks will be used to determine the assignment in the second 12-week period. Subjects with an increase in SWS by \>24 minutes will continue in PRT for the 2nd 12 weeks of the trial, while participants with \<24 minutes increase in SWS will transition to endurance training (ET).

OTHERDelayed Exercise Training (DE)

PD subjects randomized to the exercise control group (1:1) will not exercise during the first 12 weeks of the study. During that time, they will be asked not to change their physical activity levels or dietary habits. All participants in the delayed-exercise group will begin PRT at completion of the 1st 12-week period.

OTHEREndurance Training (ET)

Non-responders to PRT will transition too ET during 2nd 12 weeks of the study. This intervention is supervised endurance training, 3 times per week for 12 weeks. Each session lasts approximately 75 min., comprised of warm-up, stimulus phase for 50-60 min., and cool-down. Sessions are split between cycle ergometer and treadmill exercise. Participant heart rate is monitored to maintain target exercise intensity of 60-80% (±5%) of heart rate reserve (HRR).