Parkinson DiseaseNCT04796506
Slow Wave Sleep as a Biomarker of Rehabilitation-induced Cognitive Improvement in PD
A study testing Progressive Resistance Training (PRT), Delayed Exercise Training (DE) and Endurance Training (ET) in people with Parkinson Disease, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 100 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Progressive Resistance Training (PRT), Delayed Exercise Training (DE) and Endurance Training (ET)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 31 Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: 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).
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Progressive Resistance Training (PRT), Delayed Exercise Training (DE), Endurance Training (ET)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Resistance Training (PRT)Other
Also called PRT
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
Also called ET
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Progressive Resistance Training (PRT); Other: Delayed Exercise Training (DE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognition in Stroop inhibition
Change in executive function on the Stroop inhibition
Measured: Baseline to twelve weeks
Secondary outcomes (1)
Change in slow wave sleep (SWS)
Change in slow wave sleep as measured by polysomnography
Measured: Change from baseline to twelve week and change from twelve weeks to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Jul 2021
- Primary completion31 May 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Amy Amara, MD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796506
- Sponsor's protocol ID
- 22-1685
- Other IDs
- IRB-300005901, R01HD100670
- Status last verified
- Oct 2026
- First submitted
- 30 Nov 2020
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No