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NCT05204680 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.

Completed
Registry status
NA
Development phase
11
Enrollment target

NCT05204680: Completed NA study, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.

NCT05204680 is a NA study that has completed, run by St. Joseph's Hospital and Medical Center, Phoenix. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05204680, a NA study, has completed, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.

COMPLETED
Registry status
NA
Development phase
11 participants
Enrollment target

Study 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 (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 characteri

Primary Outcome

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).

Interventions

  • BEHAVIORAL Aerobic Exercise

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2022-06-01
Est. Completion 2023-10-31
Phase NA

What the finished NCT05204680 record still lists

NCT05204680 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Aerobic Exercise is the first listed.

NCT05204680 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05204680 about?

NCT05204680 is a clinical study titled "Exercise in Advanced Parkinson's Disease (PD) With Deep Brain Stimulation (DBS)". 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 dee...

What is the current status of trial NCT05204680?

This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2022-06-01. Estimated completion is 2023-10-31.

What interventions are being tested in trial NCT05204680?

The interventions under investigation include: Aerobic Exercise (BEHAVIORAL).

Who is sponsoring clinical trial NCT05204680?

This trial is sponsored by St. Joseph's Hospital and Medical Center, Phoenix, which has 44 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05204680's enrollment target sits among peer trials

11 1927th of 2000 higher than 74 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05204680, the US trial registry maintained by the National Library of Medicine. NCT05204680 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.