NCT06576817

Brief Summary

The goal of the study is to compare different types of high intensity circuit exercises over an 8-class training series in people with Parkinson disease. The main question it aims to answer is:

  • Does including arm and hand exercises with leg exercises improve reaction time, balance, functional measures, gait speed and quality of life? This group will be compared to a group that only does leg exercises. Participants will be asked to participate in 8 high intensity circuit exercise classes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

July 12, 2024

Last Update Submit

March 24, 2026

Conditions

Keywords

exercise

Outcome Measures

Primary Outcomes (7)

  • Trail making Test Parts A and B (timed, higher scores mean worse outcome)

    Cognitive and fine motor skills

    8-10 weeks

  • Activity-specific Balance Confidence Scale (0-100%, higher scores mean better outcome)

    Balance confidence self-report

    8-10 weeks

  • Timed Up and Go

    Balance and function

    8-10 weeks

  • 10 meter Walk Test

    Gait Speed

    8-10 weeks

  • 6 minute walk test

    endurance

    8-10 weeks

  • 9-hole peg test (timed, higher scores mean worse outcome)

    fine motor

    8-10 weeks

  • Parkinson's Disease Questionnaire - Short Form (8) (Score 0-32, higher scores mean worse outcome)

    Quality of Life

    8-10 weeks

Study Arms (2)

Lower extremity and upper extremity exercise

EXPERIMENTAL

Exercises in the circuit (8 total) will focus on the lower extremity (4) and upper extremity (4)

Other: High intensity circuit exercise class - Lower and upper extremity

Lower extremity exercise

ACTIVE COMPARATOR

Exercises in the circuit (8 total) will focus on the lower extremity (4) alone.

Other: High intensity circuit exercise class - Lower extremity alone

Interventions

Exercises performed at high intensity effort in the circuit (8 total) will focus on both the lower extremity (4) and upper extremity (4)

Lower extremity and upper extremity exercise

All exercises performed at high intensity effort in the circuit (8 total) will focus on the lower extremity alone

Lower extremity exercise

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of Parkinson's disease
  • Hoehn and Yahr level of 1 to 3
  • ability to walk independently with or without an assistive device
  • obtain medical clearance to participate in moderate or vigorous exercise.

You may not qualify if:

  • diagnosis of any neurological disease other than PD (including but not limited to stroke, dementia, and multiple sclerosis; mild cognitive impairment is not excluded)
  • bone instability (non-consolidated fractures, unstable spinal column, severe osteoporosis)
  • muscle or ligament tears
  • uncontrolled hypertension
  • uncontrolled diabetes
  • severe cardiovascular disease that impairs walking or exercise
  • a major change in medication during the study training period (pre-test to post-test)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pacific Northwest University of Health Sciences

Yakima, Washington, 98901, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Study Officials

  • Tiffany B Salido, DPT, PhD

    Pacific Northwest University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be told exercise stations may vary within-session and week to week but will not be informed that only one group has UE exercise interventions. Assessors are blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single center, two arm, pre-test post-test parallel design with up to 4 cohorts of class participants.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2024

First Posted

August 29, 2024

Study Start

February 15, 2024

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations