Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02547506
Recruitment Status : Completed
First Posted : September 11, 2015
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Stephanie Miller, University of Indianapolis

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.

Condition or disease
Parkinson Disease

Layout table for study information
Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Comparison of Cardiorespiratory Fitness Among Regular Exercisers With and Without Parkinson Disease and Across Different Modes of Group Exercise
Study Start Date : September 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Cardiorespiratory Fitness [ Time Frame: 1 day ]
    Aerobic capacity determined via VO2max protocol


Secondary Outcome Measures :
  1. Six Minute Walk Test [ Time Frame: 1 day ]
    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.

  2. Unified Parkinson's Disease Rating Scale [ Time Frame: 1 day ]
    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 motor symptoms associated with PD.

  3. StepWatch Activity Monitor [ Time Frame: 7 days ]
    Home and community stepping activity will be assessed using a StepWatch Activity Monitor (SAM) worn by the patient.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547506


Locations
Layout table for location information
United States, Indiana
University of Indianapolis
Indianapolis, Indiana, United States, 46227
Sponsors and Collaborators
University of Indianapolis
Layout table for additonal information
Responsible Party: Stephanie Miller, Professor, University of Indianapolis
ClinicalTrials.gov Identifier: NCT02547506    
Other Study ID Numbers: 0726
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Keywords provided by Stephanie Miller, University of Indianapolis:
cardiorespiratory fitness
group exercise
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases