- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04796506
Slow Wave Sleep as a Biomarker of Rehabilitation-induced Cognitive Improvement in PD
February 7, 2023 updated by: University of Colorado, Denver
Slow Wave Sleep as a Biomarker of Rehabilitation-induced Cognitive Improvement in Parkinson's Disease R01 HD100670
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).
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amy W Amara, MD, PhD
- Phone Number: 303.724.2194
- Email: amy.amara@cuanschutz.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado, Anschutz Medical Campus
-
Contact:
- Amy W Amara, MD, PhD
- Phone Number: 303.724.2194
- Email: amy.amara@cuanschutz.edu
-
Contact:
- Heather Tansksley, MOT, OTR/L
- Phone Number: 303-724-2642
- Email: HEATHER.TANKSLEY@cuanschutz.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 100 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
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).
Other Names:
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).
Other Names:
|
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.
|
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).
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cognition in Stroop inhibition
Time Frame: Baseline to twelve weeks
|
Change in executive function on the Stroop inhibition
|
Baseline to twelve weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in slow wave sleep (SWS)
Time Frame: Change from baseline to twelve week and change from twelve weeks to 24 weeks.
|
Change in slow wave sleep as measured by polysomnography
|
Change from baseline to twelve week and change from twelve weeks to 24 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Amy Amara, MD, PhD, University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 8, 2021
Primary Completion (ANTICIPATED)
March 31, 2026
Study Completion (ANTICIPATED)
March 31, 2026
Study Registration Dates
First Submitted
November 30, 2020
First Submitted That Met QC Criteria
March 11, 2021
First Posted (ACTUAL)
March 15, 2021
Study Record Updates
Last Update Posted (ESTIMATE)
February 9, 2023
Last Update Submitted That Met QC Criteria
February 7, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-1685
- R01HD100670 (NIH)
- IRB-300005901 (OTHER: UAB IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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