Indianapolis, Indiana 46227

  • Parkinson Disease

Purpose:

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.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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.


Study is Available At:


Original ID:

0726


NCT ID:

NCT02547506


Secondary ID:


Study Acronym:


Brief Title:

Comparison of Cardiorespiratory Fitness Among Regular Exercisers With and Without Parkinson Disease and Across Different Modes of Group Exercise


Official Title:

Comparison of Cardiorespiratory Fitness Among Regular Exercisers With and Without Parkinson Disease and Across Different Modes of Group Exercise


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

55 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Indianapolis


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

3


Total Enrollment:

40


Enrollment Type:

Actual


Study Dates

Start Date:September 2015
Completion Date:June 2017
Completion Type:Actual
Primary Completion Date:June 2017
Primary Completion Type:Actual
Verification Date:October 2019
Last Changed Date:October 7, 2019
First Received Date:September 9, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:StepWatch Activity Monitor
Time Frame:7 days
Safety Issues:False
Description:Home and community stepping activity will be assessed using a StepWatch Activity Monitor (SAM) worn by the patient.
Outcome Type:Secondary Outcome
Measure:Unified Parkinson's Disease Rating Scale
Time Frame:1 day
Safety Issues:False
Description:The MDS-UPDRS is a revision of the original UPDRS, and is a used to assess impairments related to PD. The inventory consists of multiple questions self-assessing an individual's activities of daily living (ADLs), as well as, an assessed examination of the
Outcome Type:Secondary Outcome
Measure:Six Minute Walk Test
Time Frame:1 day
Safety Issues:False
Description:Gait endurance will be determined by having participants walk as far as they can on a pre-determined, fixed distance course of 30 meters one way, in six minutes, resting if needed.
Outcome Type:Primary Outcome
Measure:Cardiorespiratory Fitness
Time Frame:1 day
Safety Issues:False
Description:Aerobic capacity determined via VO2max protocol

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Healthy Controls
Description:Individuals without disability who participate in group exercise other than boxing on a regular basis
Study Arm Type:Other
Arm Name:Parkinson Disease (Group Exercise)
Description:Individuals with Parkinson Disease who participate in group exercise other than boxing on a regular basis
Study Arm Type:Other
Arm Name:Parkinson Disease (Boxing)
Description:Individuals with Parkinson Disease who participate in boxing on a regular basis

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Indianapolis

Samples and Retentions

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).
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 26, 2020

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