NCT02547506

Brief Summary

The central goal of the proposed study is to generate essential pilot data necessary to support an established line of research leading to future extramural grant submissions. The aims of the current study are two-fold: 1) to compare cardiorespiratory fitness (CRF) and gait endurance across three groups of people: (1) individuals with Parkinson Disease (PD) who participate in boxing on a regular basis, (2) individuals with PD who participate in exercise other than boxing on a regular basis and (3) healthy controls of the same age who exercise on a regular basis and 2) to examine the relationship between CRF and motor symptoms of PD (bradykinesia, tremor and postural instability). Forty-five participants (15 for each group) who participate in exercise on a regular basis (at least 120 minutes of exercise per week for the past 3 months) will be recruited for this cross-sectional study. In a single testing session, participants will perform the following tests: (1) clinical performance measures and (2) a CRF assessment. A one-way ANOVA with appropriate post hoc tests will be used to examine differences in dependent variables across the three exercise groups. Relationships between CRF and clinical performance measures will be evaluated with Pearson's correlation coefficients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 9, 2019

Status Verified

October 1, 2019

Enrollment Period

1.8 years

First QC Date

September 9, 2015

Last Update Submit

October 7, 2019

Conditions

Keywords

cardiorespiratory fitnessgroup exercise

Outcome Measures

Primary Outcomes (1)

  • Cardiorespiratory Fitness

    Aerobic capacity determined via VO2max protocol

    1 day

Secondary Outcomes (3)

  • Six Minute Walk Test

    1 day

  • Unified Parkinson's Disease Rating Scale

    1 day

  • StepWatch Activity Monitor

    7 days

Study Arms (3)

Parkinson Disease (Boxing)

Individuals with Parkinson Disease who participate in boxing on a regular basis

Parkinson Disease (Group Exercise)

Individuals with Parkinson Disease who participate in group exercise other than boxing on a regular basis

Healthy Controls

Individuals without disability who participate in group exercise other than boxing on a regular basis

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 45 individuals will be enrolled in this cross-sectional study. Three groups will each consist of 15 individuals (individuals with Parkinson Disease that participate in boxing, individuals with Parkinson disease that participate in group exercise other than boxing, and individuals without disability that participate in group exercise other than boxing).

You may qualify if:

  • All participants included in this study must be between the ages of 55 and 75
  • Be able to ambulate independently without physical assistance, assistive device, or lower extremity orthosis
  • Be able to follow at least 3-step verbal commands
  • Participate in a community-based group exercise program
  • Be classified as regular exercisers by participating in 120 minutes per week for at least 3 months
  • And have a physician's consent to undergo a graded exercise test (GXT).
  • Furthermore, only participants that are identified as low or moderate risk for cardiovascular disease based on ACSM's risk stratification guidelines will be included in the study.
  • Participants for the two PD groups must have a diagnosis of idiopathic PD
  • Have a Hoehn-Yahr score of 1, 2, or 3
  • And either participate regularly in boxing training at Rock Steady Boxing or participate in another community-based group exercise program on a regular basis, classified as 120 minutes per week for at least 3 months.

You may not qualify if:

  • Participants may not be included in the study if they have had any surgery in the past 6 months
  • Current musculoskeletal or complications from other health issues that influence walking.
  • The participants without disability cannot be involved in the study if they have any preexisting neurological conditions.
  • Participants with PD cannot be involved in the study if they have preexisting neurological conditions other than idiopathic PD (e.g. no diagnosis of Parkinson Plus syndrome), past brain surgery or implantation of a deep brain stimulator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Indianapolis

Indianapolis, Indiana, 46227, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2015

First Posted

September 11, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

October 9, 2019

Record last verified: 2019-10

Locations