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

NCT04796506 | Recruiting DMC

• 3 other identifiers: 22-1685IRB-300005901R01HD100670
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Change in Cognition in Stroop inhibition

  Change in executive function on the Stroop inhibition

  Baseline to twelve weeks

Secondary Outcomes (1)

• Change in slow wave sleep (SWS)

  Change from baseline to twelve week and change from twelve weeks to 24 weeks.

Study Arms (2)

Exercise Group

ACTIVE COMPARATOR

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).

Other: Progressive Resistance Training (PRT); Other: Endurance Training (ET)

Delayed Exercise Group

PLACEBO COMPARATOR

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.

Other: Progressive Resistance Training (PRT); Other: Delayed Exercise Training (DE)

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).

Also known as: PRT

Delayed Exercise Group; Exercise Group

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.

Delayed Exercise Group

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).

Also known as: ET

Exercise Group

Eligibility Criteria

• Age: 45 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Endurance Training

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Amy Amara, MD, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy W Amara, MD, PhD

CONTACT

303.724.2194; amy.amara@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Interpretation of polysomnography and cognitive performance will be blinded to intervention assignment.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PD subjects will be randomized (1:1) to the progressive resistance training (PRT) rehabilitation group or the delayed exercise (DE) control group (wait 12 weeks and begin resistance training). Change in slow wave sleep (SWS) from baseline to 12-weeks will be used to determine the arm assignment in the second 12-week period of the trial for the original PRT group. Specifically, participants with an increase in SWS (responders) will continue in PRT for the 2nd 12 weeks of the trial, while non-responders (participants without increase in SWS) will transition to endurance training (ET) to assess if PRT followed by ET can enhance response in these non-responders.

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: March 15, 2021
• Study Start: July 1, 2021
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)