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

Conditions

• Parkinson Disease

Eligibility Criteria

Sex

ALL

Age

45 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Progressive Resistance Training (PRT) — OTHER
  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).
• Delayed Exercise Training (DE) — OTHER
  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.
• Endurance Training (ET) — OTHER
  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).

Study Details

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).

Key Dates

Start date

Jul 1, 2021

Status verified

Jun 2024

Primary completion

Mar 31, 2026

Completion

Mar 31, 2026

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: Exercise Group
  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).
• Placebo Comparator: Delayed Exercise Group
  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 Measure

Change in Cognition in Stroop inhibition [ Time Frame: Baseline to twelve weeks ]

Central Contacts

• Amy W Amara, MD, PhD
  303.724.2194
  [email protected]

Locations (1)

Find similar trials in Aurora, CO

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