Exercise for Cognitive Excellence in Parkinson's Disease

NCT05720468 | Recruiting

• 1 other identifier: K23NS123506
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and feasibility of a home-based, virtually-supervised, combined high intensity endurance and resistance training program in people with Parkinson's disease. It will also evaluate the effects of exercise on cognition and underlying exercise-related biological markers (biomarkers).

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• Average percent heart rate maximum (HR max)

  The overall average percent HR max will be compared to the target percent HR max (80-85 percent).

  From weeks 5-26, every exercise session

• Average repetition maximum

  The overall average repetition maximum for resistance exercise will be compared to the target repetition maximum (10-repetition maximum)

  From weeks 5-26, every exercise session

• Average number of days per week exercised

  The average number of days per week exercised will be compared to target adherence (5 days/week of exercise)

  From weeks 5-26, every week

Secondary Outcomes (10)

• Change in cognitive function

  Baseline and 26 weeks

• Change in motor symptoms of Parkinson's disease

  26 weeks

• Change in biomarker of aging

  Baseline and 26 weeks

• Change in biomarker of aging

  Baseline and 26 weeks

• Change in biomarker of stress

  Baseline and 26 weeks

Other Outcomes (9)

• Change in isokinetic strength

  Baseline and 26 weeks

• Change in isokinetic strength

  Baseline and 26 weeks

• Change in fitness

  Baseline and 26 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

Participants randomized to the exercise group will receive 26 weeks of home-based, combined endurance and resistance training program under guidance and virtual supervision from exercise trainers. Exercise will be performed 5 days per week, with 3 days of endurance training using treadmill and 2 days of resistance training.

Other: Exercise

Waitlist Control Group

PLACEBO COMPARATOR

The control group will continue usual level of physical activity the participants were doing prior to enrollment in the study. At the end of the 26 week study period, participants will be offered the chance to participate in the same home-based, combined endurance and resistance training program.

Other: No Exercise

Interventions

Exercise OTHER

Combined endurance and resistance exercise training

Exercise

No Exercise OTHER

Continue usual level of physical activity; option to participate in exercise training program after 26-week intervention period

Waitlist Control Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic Parkinson's disease (PD) based on MDS criteria, with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism.
• Modified Hoehn and Yahr stage less than 4
• Age 40-80 years at time of screening
• If being treated with PD symptomatic medications (i.e.g., rasagiline, carbidopa/levodopa, dopamine agonists, amantadine, anti-cholinergics), stable doses for greater than or equal to 2 months prior to baseline. If not being treated with PD symptomatic medication at time of screening, deemed unlikely to require symptomatic medication for next 6 months.

You may not qualify if:

• A diagnosis of atypical parkinsonism, drug-induced parkinsonism, essential tremor, primary dystonia or other diagnoses that explain symptoms other than PD.
• A diagnosis of a significant neurological disease other than PD that would interfere with ability to perform study procedures or assessments.
• Significant cognitive impairment defined as Montreal Cognitive Assessment (MoCA)\<23 or any impairment that would, in the opinion of the investigator, interfere with ability to follow exercise directions.
• Beck Depression Inventory II (BDI) score \> 16, indicating depression that precludes ability to exercise.
• Use of neuroleptics/dopamine receptor blockers for more than 30 days in the year prior to baseline visit, or any use within 30 days of baseline visit.
• Recent use of psychotropic medications (e.g., recent use of psychotropic medications (i.e., anxiolytics, hypnotics, benzodiazepines, antidepressants) where dosage has not been stable for more than 30 days prior to screening.
• Presence of known cardiovascular, metabolic, or renal disease or individuals with major signs or symptoms suggestive of cardiovascular, metabolic, or renal disease without medical clearance to participate in the exercise program.
• Presence of any of the following laboratory abnormalities on screening labs:
• Abnormal liver function (AST or ALT more than 2 times the upper limit of normal)
• Abnormal renal function (creatinine clearance calculated by the Cockcroft-Gault equation \<50mL/min or estimated glomerular filtration rate using the MDRD4 equation or the CKD-EPI equation \<45mL/min/1.73m2)
• Complete Blood Count out of range on screening labs and physician's judgment that abnormal value is clinically significant.
• Uncontrolled hypertension (resting blood pressure \>150/90 mmHg).
• Orthostatic hypotension and standing systolic BP below 100. Orthostatic hypotension is a reduction of systolic blood pressure of at least 20 mm Hg or diastolic blood pressure of at least 10 mm Hg within 3 minutes of standing.
• Already participating in 120 minutes or more of moderate intensity exercise per week.
• Serious illness (requiring systemic treatment and/or hospitalization) within the last 4 weeks.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94518, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

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)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nijee Luthra, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nijee Luthra, MD, PhD

CONTACT

(415) 502-2960; nijee.luthra@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: July 20, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)