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Parkinson DiseaseDBS ExerciseNCT05204680

Exercise in Advanced Parkinson's Disease (PD) With Deep Brain Stimulation (DBS)

A study testing Aerobic Exercise in people with Parkinson Disease, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project is a 3-month prospective study assessing the immediate and long-term changes associated with aerobic exercise in quality-of-life measures, nonmotor scores, brief neuropsychological batteries, and local field potentials (LFPs) in those with Parkinson's Disease (PD) who have undergone deep brain stimulation… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
Aerobic Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
1 Jun 2022to 31 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals with Parkinson's Disease
  • Age >18
  • H\&Y stage 1-3 in the medication on and stimulation on state
  • History of STN DBS
  • Able to tolerate exercise from a cardiovascular, cognitive, and orthopedic perspective
  • Not on beta-blockers, as we will be using heart rate-based targets
  • Stable medication and stimulation for 60 days prior to baseline visit
  • Access to exercise equipment

Who cannot join

  • Medical comorbidities that preclude safe exercise per the discretion of the principal investigator
  • Regular exercisers

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

Other trials in United States

About this study

This project is a 3-month prospective study assessing the immediate and long-term changes associated with aerobic exercise in quality-of-life measures, nonmotor scores, brief neuropsychological batteries, and local field potentials (LFPs) in those with Parkinson's Disease (PD) who have undergone deep brain stimulation (DBS) surgery for management of their symptoms. In this study, the investigators will assess the feasibility of an aerobic exercise regimen in those with advanced PD and DBS, characterize the immediate and long-term changes in neuronal activity with exercise in PD, and assess the nonmotor impact of exercise in individuals with advanced PD and DBS.

The investigators will recruit individuals who are not regular exercisers and develop an individualized 3-month exercise plan with the assistance of physical therapists, using heart rate targets for moderate exercise. Outcomes will be measured at baseline and following 3-months of regular exercise. Field potentials will be noted at baseline, during exercise every 2 weeks, and then a final baseline at the end of 3 months in on-medication and on-stimulation states. This will allow for characterization of field potential changes over time both during exercise as efficiency improves as well as impact on baseline neuronal activity in the resting state. This study is novel in that most aerobic exercise studies target early PD subjects and rarely include those who have undergone DBS surgery. The study will specifically focus on the feasibility of developing an aerobic exercise regimen in those with more advanced disease as well as gathering preliminary data on the impact it will have on motor and nonmotor features in this cohort. In addition to the clinical outcomes, investigators are now able to capture neuronal activity with novel FDA-approved DBS technology, allowing us to non-invasively monitor real-time changes in the basal ganglia in those who have undergone DBS surgery. This study will also aim to characterize baseline neuronal activity in this cohort and monitor for changes that occur during exercise as well as determine if there is a change in baseline neuronal activity as exercise tolerance improves and with consistent, regular aerobic exercise.

Being tested
Aerobic Exercise
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic ExerciseBehavioural

    The participant will work with the physical therapist on an exercise regimen.

Study groups in NCT05204680
Study groupRoleWhat they receive
Aerobic ExerciseExperimentalThe participant will work with the physical therapist on an exercise regimen and first session will be supervised with the therapist. Exercise protocols will include a 15-minute warmup and cooldown session as well. To allow for increased participation and accessibility, the means of aerobic exercise will not be restricted and any safe mechanism of exercise will be allowed e.g., treadmill, stationary bike, etc. Subjects will be provided an activity monitor (Phillips HealthBand Monitor) for the duration of study participation and receive training on how to use it, including marking events with start and stop of exercise sessions and tracking heart rate. The device can track type of activity as well as cardio fitness index and VO2max.
Receives: Behavioral: Aerobic Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of study participants who complete at least 80% of the exercise sessions during the 3-month follow-up period

    For Objective #1, feasibility of the aerobic exercise regimen will be assessed by the adherence proportion, defined as proportion of study participants who complete at least 80% of the exercise sessions during the 3-month follow-up period. Precision of the proportion estimate will be assessed by the 95% Clopper-Pearson confidence interval (CI).

    Measured: Following 3-month exercise regimen

Secondary outcomes (3)

  1. Change in MDS-NMS score

    For Objective #2, the primary outcome, the change in total (Movement Disorder Society - Non-Motor Scale (MDS-NMS) score from baseline to three months. MDS-NMS is reported as a score from 0-334, with higher scores being worse. In secondary analysis we will summarize and compare the score of each individual domain between the two time points (depression, anxiety, apathy, psychosis, impulse control, cognition, orthostatic hypotension, urinary, sexual, gastrointestinal, sleep, pain, and other).

    Measured: Following 3-month exercise regimen

  2. Change in number of symptoms reported

    Proportion of subjects with each non-motor symptom (with score of at least 1). The total number of symptoms and number of symptoms within each domain will be compared using the Wilcoxon signed-rank test.

    Measured: Following 3-month exercise regimen

  3. Change in LFP

    For the exploratory objective to study changes in neuronal activity, we will use linear and non-linear mixed effects models to study the trend in the biweekly measurements of local field potentials (LFPs) parameters over time. The LFP parameters, including power, sample entropy, arrhythmicity, and asymmetry primarily in beta bands but will also explore other frequencies, will be transformed, if needed, to achieve approximate normality. Random intercepts based on patient and STN will be included in the model. In addition, changes in LFP parameters from baseline to various time points will be associated with changes in total and domain-specific MDS-NMS scores from baseline to three months using linear regression models.

    Measured: Following 3-month exercise regimen

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2022
  2. Study start1 Jun 2022
  3. Primary completion31 Oct 2023
  4. Study completion31 Oct 2023

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05204680
Sponsor's protocol ID
22-500-203-70-04
Acronym
DBS Exercise
Status last verified
Nov 2023
First submitted
23 Dec 2021
Last updated
21 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Exercise in people with Parkinson Disease, run by St. Joseph's Hospital and Medical Center, Phoenix 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 8 inclusion and 2 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: finished, as of the sponsor's last update on 21 Nov 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of study participants who complete at least 80% of the exercise sessions during the 3-month follow-up period (time frame: Following 3-month exercise regimen). 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 NCT05204680.

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 21 Nov 2023.

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