Parkinson DiseaseNCT06823921
Cognitive Effects of Exercise in Parkinson's Disease
A study testing Exercise in people with Parkinson Disease, run by Sule Tinaz at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease
- Age 40 year and above
- Willingness and ability to participate in HIIT exercise classes
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of High-Intensity Interval Training (HIIT) on Cognitive Function and Quality of Life in Parkinson's Disease: A Pilot Clinical Trial
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Exercise
- Keywords
- exercise, high-intensity interval training, cognitive function, MRI
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called HIIT
HIIT will include aerobic, strength, and balance exercises and boxing
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training | Experimental | Participants in the HIIT group will be expected to attend 3 exercise classes per week for 3 months Receives: Other: Exercise |
| Control | No intervention | Participants in the control group will continue their standard care and usual physical activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months and 6 months
Secondary outcomes (2)
Executive function composite T-score
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.
Measured: 3 months and 6 months
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) memory domain index score
Examines verbal and visual memory performance and calculates an index score (range: 40-160). Higher score indicates better performance.
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start11 Feb 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sule Tinaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sule Tinaz, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823921
- Sponsor's protocol ID
- 2000039232
- Status last verified
- Jan 2026
- First submitted
- 6 Feb 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an early-phase pilot study to determine feasibility.
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.
PubMed 38336768
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Intensity Interval Training (HIIT) on Cognitive Function and Quality of Life in Parkinson's Disease: A Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT06823921
- Acronym / sponsor ID
- 2000039232
- Conditions
- Parkinson Disease
- Keywords
- exercise, high-intensity interval training, cognitive function, MRI
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sule TinazUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training | Experimental | Other: ExerciseParticipants in the HIIT group will be expected to attend 3 exercise classes per week for 3 months |
| Control | No intervention | –Participants in the control group will continue their standard care and usual physical activities |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of idiopathic Parkinson's disease
- Age 40 year and above
- Willingness and ability to participate in HIIT exercise classes
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: HIITHIIT will include aerobic, strength, and balance exercises and boxing | Other | High-intensity interval training |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Results publication: PubMed 38336768de 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.
- Individual participant dataSharing planned: No. This is an early-phase pilot study to determine feasibility.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Parkinson Disease, run by Sule Tinaz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life in Neurological Disorders (Neuro-QoL) cognitive function survey (time frame: 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06823921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.