Home-based exercise program for cognitive improvement in Parkinson's disease

Exercise for Cognitive Excellence in Parkinson's Disease

This study is testing whether a home-based exercise program can help improve thinking skills in people with Parkinson's disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT05720468 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and feasibility of a home-based, virtually-supervised exercise program combining high-intensity endurance and resistance training for individuals with Parkinson's disease. It aims to assess the effects of this exercise regimen on cognitive function and identify biological markers associated with exercise and cognitive health. Thirty-six participants will be randomized into an exercise group or a waitlist control group for 26 weeks, with cognitive assessments and biomarker measurements taken before and after the intervention. The study seeks to understand how exercise can counter cognitive decline in Parkinson's disease.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40-80 with a diagnosis of idiopathic Parkinson's disease who are stable on their medications.

Not a fit: Patients with atypical parkinsonism or significant neurological diseases other than Parkinson's may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could enhance cognitive function and overall quality of life for patients with Parkinson's disease.

How similar studies have performed: Other studies have shown positive outcomes with exercise interventions in Parkinson's disease, suggesting this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Modified Hoehn and Yahr stage less than 4
3. Age 40-80 years at time of screening
4. 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.

Exclusion Criteria:

1. A diagnosis of atypical parkinsonism, drug-induced parkinsonism, essential tremor, primary dystonia or other diagnoses that explain symptoms other than PD.
2. A diagnosis of a significant neurological disease other than PD that would interfere with ability to perform study procedures or assessments.
3. 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.
4. Beck Depression Inventory II (BDI) score \> 16, indicating depression that precludes ability to exercise.
5. 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.
6. 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.
7. 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.
8. Presence of any of the following laboratory abnormalities on screening labs:

   1. Abnormal liver function (AST or ALT more than 2 times the upper limit of normal)
   2. 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)
   3. Complete Blood Count out of range on screening labs and physician's judgment that abnormal value is clinically significant.
9. Uncontrolled hypertension (resting blood pressure \>150/90 mmHg).
10. 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.
11. Already participating in 120 minutes or more of moderate intensity exercise per week.
12. Serious illness (requiring systemic treatment and/or hospitalization) within the last 4 weeks.
13. History of any other medical problem or injury that may interfere with ability to exercise.
14. Condition that precludes the safe performance of routine lumbar puncture, including:

    1. INR \> 1.4 or other coagulopathy
    2. Platelet cell count of \< 50,000/μL
    3. Infection at the desired lumbar puncture site
    4. Taking anti-coagulant medication within 90 days of baseline (Note: low dose aspirin is permitted)
    5. Suspected non-communicating hydrocephalus or intracranial mass
    6. Prohibitive lumbar spinal disease
15. Enrollment in another investigational study that includes an intervention; participation in non-interventional studies may be permitted
16. Receipt of any non-PD investigational product or device or participation in a non-PD drug research study within a period of 30 days (or 5 half-lives of the drug, whichever is longer) before baseline.
17. History of frequent falls (i.e. falling multiple times per week) or considered high fall risk based on investigator assessment
18. Lack of access to computer/tablet and WiFi or any other technical challenges that in the opinion of the investigator would prevent participation in the virtually supervised exercise training program.

Where this trial is running

San Francisco, California

• University of California San Francisco — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Nijee Luthra, MD, PhD — University of California, San Francisco
• Study coordinator: Nijee Luthra, MD, PhD

Conditions Parkinson Disease