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Clinical Trials/NCT06576817
NCT06576817RecruitingNot Applicable

Comparison of High-intensity Interval Circuit Training With Upper Extremity and Lower Extremity Training Versus Lower Extremity Training Alone in People With Parkinson Disease

Pacific Northwest University of Health Sciences2 sites in 1 country64 target enrollmentStarted: February 15, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
64
Locations
2
Primary Endpoint
Trail making Test Parts A and B (timed, higher scores mean worse outcome)

Study Overview

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.

Detailed Description

People with Parkinson disease will be recruited from the community and randomized into 2 equal groups: high intensity interval circuit training with lower extremity (LE) and lower and upper extremity (LEUE) training. The study will be composed of a baseline assessment, 8 group class sessions, and a post-intervention assessment. The baseline assessment will include demographics, disease and fall history and outcome measure collection. Group class sessions will include concurrent group warmup, followed by an 8-station circuit performed with high intensity intervals, and a cool-down. The circuit will include 4 stations performed by both the LE and LEUE groups and 4 stations specific to each intervention group, including 4 additional LE exercise stations for the LE group and 4 UE specific stations for the LEUE group. The stations that differ will not be adjacent to one another nor specifically indicated as different. The stations that differ will mirror similar aspects of function (ie, strength, reaction time, etc.) for the UE and LE stations. 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. After conclusion of the class series, post-intervention balance and stepping outcomes will be reassessed.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

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

Time Frame: 8-10 weeks

Cognitive and fine motor skills

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

Time Frame: 8-10 weeks

Balance confidence self-report

Timed Up and Go

Time Frame: 8-10 weeks

Balance and function

10 meter Walk Test

Time Frame: 8-10 weeks

Gait Speed

6 minute walk test

Time Frame: 8-10 weeks

endurance

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

Time Frame: 8-10 weeks

fine motor

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

Time Frame: 8-10 weeks

Quality of Life

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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