Recruiting

Exercise

Sponsor:

University of Nevada, Las Vegas

Code:

NCT05854524

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

Interventions

Aerobic exercise

Study Details

Brief summary:

The purpose of this study is to explore the relationships of exercise on inflammation in the body of older adults and people with Parkinson's disease (PD). This is important research for older adults but is especially important for people with PD because neuroinflammation is the main pathological mechanism that is responsible for neuron cell death in this neurodegenerative disease. As PD is a progressive disease, halting or slowing the degeneration is an important research target. Halting or slowing the disease progress is known as neuroprotection. Exercise is an attractive therapeutic treatment for people with PD as it has a lot of multi-systemic benefits, but also there is a lot of evidence to suggest that it helps improve symptoms and slow the progression of the disease. Exercise has been theorized to decrease inflammation and, therefore, has a lot of promise as a neuroprotective agent in slowing or halting the degeneration in PD. Unfortunately, there is not a lot of research that has looked into the effect of exercise on the biological processes of inflammation. Thus, the purpose of this study is to investigate the biological evidence that underlies the positive effect of exercise in people with PD.

Conditions

Parkinson Disease

Study ID

NCT05854524

Start date

Aug 29, 2024

Status verified date

Aug, 2024

Completion date

Dec 30, 2026

Anticipated

Primary completion date

May 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

Inclusion criteria for PwP:

  • 30-85 years old
  • Neurologist-diagnosed PD
  • Able to participate in 30 minutes of continuous moderate aerobic exercise with 2-3 short breaks per self-report.

Inclusion criteria for controls:

  • 30-85 years old
  • No major medical diagnoses
  • Able to participate in 30 minutes of continuous moderate aerobic exercise with 2-3 short breaks per self-report.

Exclusion Criteria for both PD group and controls:

  • Diagnoses, identified by self-report, that would preclude exercise participation (e.g., heart arrhythmias, uncontrolled blood pressure, exercise-induced asthma).
  • Those not deemed ready for exercise participation. Participants will be screened for exercise participation using the Physical Activities Readiness Questionnaire + which is used as a screening tool for all ages to identify risk factors that would clear someone for participation in moderate physical exercise.
  • Those with dementia will be excluded because there are self-report questionnaires in this study. This will be identified using the Montreal Cognitive Assessment and a score at or below a 21. Participants with mild cognitive impairment and no impairment will be included.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Parkinson Disease

Participants diagnosed with Parkinson disease (PD) will the main arm of the study and will be compared to the control group.

active comparator: Control

Older, adults who are age- and sex-matched to the PD participants.

Interventions

Aerobic exercise

The intervention is exercise and there are no drugs or devices used in this trial. The exercise consists of two intensity levels of a 30-minute aerobic exercise intervention with both arms crossing over to both conditions: low intensity exercise (60-70% of estimated maximum heart rate (EMRH)) and moderate-vigorous intensity exercise (75-85% of EMHR).

Primary outcome measure

  • Exercise and inflammatory milieu [ Time Frame: Baseline measurement only ]
  • Inflammatory milieu comparison to controls [ Time Frame: Baseline measurement only ]
  • Exercise dose and biomarkers [ Time Frame: 30 minutes prior to the exercise (pre measurement) and 30 minutes after completing the 30-minute aerobic exercise condition (post measurement) . Both conditions are separated by one week. ]
  • Biomarkers in Parkinson Disease [ Time Frame: 30 minutes prior to the exercise (pre measurement) and 30 minutes after completing the 30-minute aerobic exercise condition (post measurement) . Both conditions are separated by one week ]

Central Contacts and Locations

Central contacts

Merrill Landers, DPT, PhD

17028951377merrill.landers@unlv.edu

Locations

Gait and Balance Laboratory, 217 Bigelow Health Sciences Building, UNLV

Recruiting

Las Vegas, Nevada, United States, 89154

Contacts

Merrill Landers, PT, DPT, PhD

7028951377merrill.landers@unlv.edu

merrill.landers@unlv.edu

More Information

Sponsor

University of Nevada, Las Vegas

Last update posted

Sep 3, 2024

Last verified

Aug, 2024

Keywords

  • Exercise
  • Inflammation
  • Physical activity
  • Neuroprotection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by University of Nevada, Las Vegas on 2024-09-03.