Cognitive Effects of Exercise in Parkinson's Disease

NCT ID: NCT06823921

Last Updated: 2026-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-11

Study Completion Date

2027-03-01

Brief Summary

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This pilot study will evaluate the short-term (3 months) and long-term (6 months) effectiveness of a high-intensity interval training (HIIT) program in improving cognitive function and self-efficacy in individuals with PD.

Detailed Description

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Participants will be assigned to either the HIIT group, which will engage in 3 classes per week, or a standard-of-care control group, which will include people who will continue their standard care and usual physical activities but do not plan on partaking in additional structured exercise interventions for 3 months (except for physical and occupational therapy if medically necessary). Cognitive functions will be measured using standardized tests (Stroop, Trail Making Test-B (TMT-B), verbal fluency (using letters F-A-S), and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)), alongside assessing subjective ratings of daily cognitive function using the Neuro Quality of Life - Cognitive Function (Neuro-QoL CF) survey. Secondary outcomes will include self-efficacy measures, specifically regarding goal achievement, managing emotions and daily activities. We will also aim to obtain brain functional MRI (fMRI) and neuromelanin-sensitive MRI (NM-MRI) data from a subset of participants to measure the brain effects of HIIT as exploratory outcomes.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High-intensity interval training

Participants in the HIIT group will be expected to attend 3 exercise classes per week for 3 months

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

HIIT will include aerobic, strength, and balance exercises and boxing

Control

Participants in the control group will continue their standard care and usual physical activities

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

HIIT will include aerobic, strength, and balance exercises and boxing

Intervention Type OTHER

Other Intervention Names

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HIIT

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of idiopathic Parkinson's disease
* Age 40 year and above
* Willingness and ability to participate in HIIT exercise classes

Exclusion Criteria

* Non-English speaking
* Neuropsychiatric disorder other than Parkinson's disease and comorbid depression and anxiety (e.g., stroke, epilepsy, brain tumor, multiple sclerosis, schizophrenia, bipolar disorder, obsessive compulsive disorder, etc.)
* High levels of exercise at baseline (exercising at high intensity at least 3 times per week or moderate intensity at least 5 times per week)
* Hoehn \& Yahr disease stage \> 3 (physically not independent)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sule Tinaz

OTHER

Sponsor Role lead

Responsible Party

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Sule Tinaz

Associate Professor of Neurology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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de Laat B, Hoye J, Stanley G, Hespeler M, Ligi J, Mohan V, Wooten DW, Zhang X, Nguyen TD, Key J, Colonna G, Huang Y, Nabulsi N, Patel A, Matuskey D, Morris ED, Tinaz S. Intense exercise increases dopamine transporter and neuromelanin concentrations in the substantia nigra in Parkinson's disease. NPJ Parkinsons Dis. 2024 Feb 9;10(1):34. doi: 10.1038/s41531-024-00641-1.

Reference Type RESULT
PMID: 38336768 (View on PubMed)

Other Identifiers

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2000039232

Identifier Type: -

Identifier Source: org_study_id

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