Cognitive Effects of Exercise in Parkinson's Disease

NCT06823921 | Enrolling By Invitation

• 1 other identifier: 2000039232
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

exercise; high-intensity interval training; cognitive function; MRI

Outcome Measures

Primary Outcomes (1)

• Quality of Life in Neurological Disorders (Neuro-QoL) cognitive function survey

  Subjective measures of cognitive functioning in daily life. It captures aspects of cognitive functioning such as attention, memory, and executive function. The average T-score is 50. Higher score indicates better performance.

  3 months and 6 months

Secondary Outcomes (2)

• Executive function composite T-score

  3 months and 6 months

• Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) memory domain index score

  3 months and 6 months

Study Arms (2)

High-intensity interval training

EXPERIMENTAL

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

Other: Exercise

Control

NO INTERVENTION

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

Interventions

Exercise OTHER

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

Also known as: HIIT

High-intensity interval training

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sule Tinaz: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

• 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.

  PMID: 38336768 RESULT

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 12, 2025
• Study Start: February 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)