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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547506
• Other study ID #: 0726
• Status: Completed
• Start date: September 2015
• Est. completion date: June 2017

Study information

• Verified date: October 2019
• Source: University of Indianapolis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
United States	University of Indianapolis	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
University of Indianapolis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory Fitness	Aerobic capacity determined via VO2max protocol	1 day
Secondary	Six Minute Walk Test	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.	1 day
Secondary	Unified Parkinson's Disease Rating Scale	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.	1 day
Secondary	StepWatch Activity Monitor	Home and community stepping activity will be assessed using a StepWatch Activity Monitor (SAM) worn by the patient.	7 days