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

Primary Purpose

Parkinson Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Progressive Resistance Training (PRT)

Delayed Exercise Training (DE)

Endurance Training (ET)

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

45 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion:

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:

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.

Sites / Locations

University of Colorado, Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Exercise Group

Delayed Exercise Group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Change in Cognition in Stroop inhibition

Change in executive function on the Stroop inhibition

Secondary Outcome Measures

Change in slow wave sleep (SWS)

Change in slow wave sleep as measured by polysomnography

Full Information

NCT ID

NCT04796506

First Posted

November 30, 2020

Last Updated

February 7, 2023

Sponsor

University of Colorado, Denver

Collaborators

National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

1. Study Identification

Unique Protocol Identification Number

NCT04796506

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 8, 2021 (Actual)

Primary Completion Date

March 31, 2026 (Anticipated)

Study Completion Date

March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

Collaborators

National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

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.

Masking

Outcomes Assessor

Masking Description

Interpretation of polysomnography and cognitive performance will be blinded to intervention assignment.

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exercise Group

Arm Type

Active Comparator

Arm Description

Arm Title

Delayed Exercise Group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Progressive Resistance Training (PRT)

Other Intervention Name(s)

PRT

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Delayed Exercise Training (DE)

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Endurance Training (ET)

Other Intervention Name(s)

Intervention Description

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).

Primary Outcome Measure Information:

Title

Change in Cognition in Stroop inhibition

Description

Change in executive function on the Stroop inhibition

Time Frame

Baseline to twelve weeks

Secondary Outcome Measure Information:

Title

Change in slow wave sleep (SWS)

Description

Change in slow wave sleep as measured by polysomnography

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion: 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: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amy W Amara, MD, PhD

Phone

303.724.2194

amy.amara@cuanschutz.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amy Amara, MD, PhD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado, Anschutz Medical Campus

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heather Tansksley, MOT, OTR/L

Phone

303-724-2642

HEATHER.TANKSLEY@cuanschutz.edu

First Name & Middle Initial & Last Name & Degree

Amy W Amara, MD, PhD

Phone

303.724.2194

amy.amara@cuanschutz.edu

12. IPD Sharing Statement

Plan to Share IPD

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

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