Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT04796506

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Progressive Resistance Training (PRT)

Delayed Exercise Training (DE)

Endurance Training (ET)

Study Details

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

Study ID

NCT04796506

Start date

Jul 1, 2021

Status verified date

Jun, 2024

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Progressive Resistance Training (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)

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)

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

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

Central Contacts and Locations

Central contacts

Amy W Amara, MD, PhD

303.724.2194amy.amara@cuanschutz.edu

Locations

University of Colorado, Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Madison Sleyster

303-724-2931madison.sleyster@cuanschutz.edu

Amy W Amara, MD, PhD

303.724.2194amy.amara@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Oct 1, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-10-01.