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Enrolling by invitation NCT06823921

Cognitive Effects of Exercise in Parkinson's Disease

No phase Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • Other Exercise
    HIIT will include aerobic, strength, and balance exercises and boxing

Primary outcome measures

  • Quality of Life in Neurological Disorders (Neuro-QoL) cognitive function survey [Time frame: 3 months and 6 months]
Secondary outcome measures (2)
  • Executive function composite T-score [Time frame: 3 months and 6 months]
  • Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) memory domain index score [Time frame: 3 months and 6 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Yale University — New Haven

Publications

  • 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

Identifiers

NCT: NCT06823921 · 2000039232

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗