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

Inclusion Criteria6

clinical diagnosis of idiopathic PD, based on the presence of bradykinesia as well as at least one of the following: rest tremor, rigidity, and/or postural instability (per United Kingdom PD Brain Bank Criteria)
Hoehn and Yahr stage 2-3 (performed at screening visit)
age ≥ 45 and
on stable medications for at least 4 weeks prior to study entry without expecting to change medications for the duration of the study.
Montreal Cognitive Assessment (MoCA) score ≥ 18 and \<26 (performed at screening visit)
No contraindications to an exercise program.

Exclusion Criteria11

fails exercise readiness evaluation at screening visit
regular participation in an exercise program
cardiovascular or pulmonary disease, including uncontrolled hypertension, congestive heart failure, unstable coronary artery disease, serious arrhythmia, stroke within the past year, or chronic obstructive pulmonary disease (COPD)
shift workers
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)
inability to walk without assistance
deep brain stimulation (DBS)
known narcolepsy
untreated sleep apnea
any condition that, in the opinion of the investigator, will preclude the participant from successfully or safely completing study procedures.

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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).