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

• ClinicalTrials.gov Identifier: NCT02547506
• Recruitment Status: Completed
• First Posted: September 11, 2015
• Last Update Posted: October 9, 2019
• Sponsor: University of Indianapolis
• Information provided by (Responsible Party): Stephanie Miller, University of Indianapolis

Study Description

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

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Indiana

University of Indianapolis

Indianapolis, Indiana, United States, 46227

Sponsors and Collaborators

University of Indianapolis

More Information

• Responsible Party: Stephanie Miller, Professor, University of Indianapolis
• ClinicalTrials.gov Identifier: NCT02547506
• Other Study ID Numbers: 0726
• First Posted: September 11, 2015
• 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:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases