MedPath

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

Not Applicable
Recruiting
Conditions
Parkinson Disease
Interventions
Other: Progressive Resistance Training (PRT)
Other: Delayed Exercise Training (DE)
Other: Endurance Training (ET)
Registration Number
NCT04796506
Lead Sponsor
University of Colorado, Denver
Brief 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).

Detailed Description

Sleep impairment adversely affects cognitive function and increases risk for dementia. Slow wave sleep (SWS) or delta sleep (non-rapid eye movement (REM) stage 3; N3) is especially important for cognition due to its association with synaptic plasticity, synaptic potentiation, synaptic renormalization, and cortical reorganization, especially in prefrontal cortex. Clinically, SWS contributes to memory consolidation and language performance. The investigators have previously shown that the amount of SWS in persons with Parkinson's disease (PwP) is related to cognitive performance, especially in the domain of executive function. The investigators have also shown that exercise increases SWS in some PwP and that participants who have an exercise-induced increase in SWS also have improvement in executive function. This study will evaluate changes in cognitive function and SWS due to progressive resistance training rehabilitation (PRT). Participants who do not have an increase in SWS with PRT (non-responders) over 12 weeks will be transitioned to an endurance training (ET) intervention, while those who do have an increase in SWS (responders) will continue in PRT for an additional 12 weeks.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
120
Inclusion Criteria

Not provided

Read More
Exclusion Criteria

Not provided

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Delayed Exercise GroupDelayed Exercise Training (DE)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.
Exercise GroupProgressive Resistance Training (PRT)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).
Exercise GroupEndurance Training (ET)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).
Delayed Exercise GroupProgressive Resistance Training (PRT)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.
Primary Outcome Measures
NameTimeMethod
Change in Cognition in Stroop inhibitionBaseline to twelve weeks

Change in executive function on the Stroop inhibition

Secondary Outcome Measures
NameTimeMethod
Change in slow wave sleep (SWS)Change from baseline to twelve week and change from twelve weeks to 24 weeks.

Change in slow wave sleep as measured by polysomnography

Trial Locations

Locations (1)

University of Colorado, Anschutz Medical Campus

🇺🇸

Aurora, Colorado, United States

© Copyright 2025. All Rights Reserved by MedPath