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Enrolling by Invitation

NCT Number: NCT06823921

Cognitive Effects of Exercise in Parkinson's Disease

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

Other

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

Other names: HIIT

Primary outcomes

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

    Time frame: 3 months and 6 months

    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.

Secondary outcomes

  1. Executive function composite T-score

    Time frame: 3 months and 6 months

    Average T-scores of Trail Making Test-B, Stroop, and F-A-S verbal fluency test that are used to test executive functions. The average T-score is 50. Higher score indicates better performance.

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

    Time frame: 3 months and 6 months

    Examines verbal and visual memory performance and calculates an index score (range: 40-160). Higher score indicates better performance.

Sponsors and collaborators

Lead sponsor

Sule Tinaz

Other

Registry information

Official study title

Effects of High-Intensity Interval Training (HIIT) on Cognitive Function and Quality of Life in Parkinson's Disease: A Pilot Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 12, 2025
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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