Rock Steady Boxing: A Community Based In Person Class

Rock Steady Boxing: A Community Based In Person Class for Patients With Parkinson Disease

The purpose of this study is to evaluate the feasibility and effectiveness of a non-contact Rock Steady Boxing class delivered to participants with Parkinson's Disease via an in-person community-based program. The study will also assess the overall feasibility of integrating an in-person community program within a neuromuscular course in a Doctor of Physical Therapy program.

Specific Aim: To examine the effects of an in-person community-based Rock Steady Boxing class on the functional mobility, functional endurance, cardiovascular capacity, visual-motor reaction times, quality of life, mood/affect and overall physical activity completion and fear of falling on individuals with Parkinson's Disease.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Rock Steady Boxing Class

Detailed Description

Participants will be recruited directly from the the Brain Center (non-for-profit neurology clinic). Participants will be educated on the study but advised that their participation is voluntary and researchers will not coerce boxers to participate in the study. Once a participant agrees to participate, the Informed consent will be completed. During this time, participants will be told their participation is voluntary and they can quit at any time. he primary interventions being assessed in this study include the in-person Rock Steady Boxing Class offered at USAHS once per week. Prior to attending the Rock Steady Boxing classes, all participants must be provided with medical clearance from a referring medical doctor. The Rock Steady Boxing classes are 60-90 minutes in duration and include the following 4 components: (1) active warm up (2) functional mobility exercises (3) whole body strengthening exercises and (4) non-contact boxing exercises. During the classes, boxers' vitals are assessed using health rate monitors.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miguel Garcia, EdD; Phone Number: 4147 786-725-4047; Email: mgarcia@usa.edu
• Study Contact Backup: Name: Tatiana Godoy Bobbio, PhD; Phone Number: 4153 786-725-4053; Email: TBobbio@usa.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33134
      • Recruiting
      • University of St Augustine for Health Science
      • Contact: Miguel Garcia, EdD; Phone Number: 4147 786-725-4047; Email: mgarcia@usa.edu
      • Contact: Gabriel Somarriba, EdD; Phone Number: 4145 786-725-4045; Email: gsomarriba@usa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or Female
2. Age Range: 18 years or older
3. History of Parkinson's Disease between Hoehn and Yarh stages I and IV
4. Medical clearance from a referring medical doctor
5. Able to complete all assessments
6. Willing to complete a weekly exercise log

Exclusion Criteria:

1. Unable to complete the assessments.
2. Pregnant or is expected to become pregnant during study
3. Other reasons that may limit participation in exercises. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Rock Steady Boxing classes; The Rock Steady Boxing classes are 60-90 minutes in duration twice a week and include the following 4 components: (1) active warm up (2) functional mobility exercises (3) whole body strengthening exercises and (4) non-contact boxing exercises.	Other: Rock Steady Boxing Class; Rock Steady Boxing is a non-contact fitness program designed specifically for people with Parkinson's Disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes over time in Activities-Specific Balance Confidence Scale (ABC) from baseline to one year	The ABC is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness.	Baseline, 3 months, 6-months and 1-year post intervention
Changes in Falls Efficacy Scale - International from baseline to 1-year post	A self-administered questionnaire designed to assess fear of falling in mainly community-dwelling older population	Baseline, 3 months, 6-months and 1-year post intervention
Changes in Parkinson's Disease Fatigue Scale from baseline to 1-year post	A patient-rated scale that measures fatigue	Baseline, 3 months, 6-months and 1-year post intervention
Changes in Parkinson's Disease Questionnaire -39 from baseline to 1-year post	A 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month.	Baseline, 3 months, 6-months and 1-year post intervention
Changes in Physical Activity Scale for the Elderly (PASE) from baseline to 1-year post	The PASE measures the level of self-reported physical activity in individuals aged 65 years old or older and is comprised of items regarding occupational, household, and leisure activity during the previous 7-day period.	Baseline, 3 months, 6-months and 1-year post intervention
Changes in Berg Balance Test from baseline to 1-year post	The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.	Baseline, 3 months, 6-months and 1-year post intervention
Changes in 10-Meter Walk Test from baseline to 1-year post	The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance.	Baseline, 3 months, 6-months and 1-year post intervention
Changes in 6-Minute Walk Test from baseline to 1-year post	The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance.	Baseline, 3 months, 6-months and 1-year post intervention
Changes in Time Up and Go (TUG) from baseline to 1-year post	Measure of function with correlates to balance and fall risk	Baseline, 3 months, 6-months and 1-year post intervention
Changes in Self-Efficacy for Exercise from baseline to 1-year post	Self report measure of exercise self-efficacy	Baseline, 3 months, 6-months and 1-year post intervention
Changes in Anticipatory & Compensatory Postural Assessment form baseline to 1-year post	Electromyography measure of postural stability in standing	Baseline, 3 months, 6-months and 1-year post intervention
Changes in Rock Steady Boxing Questionnaire from 3-month post to 1-year post intervention	Self assessment of mobility and quality of life	3 months, 6-months and 1-year post intervention
Changes Physical Activity Intensity Monitoring from baseline to 1-year post intervention	Heart rate monitoring during exercise	Baseline, 3 months, 6-months and 1-year post intervention

Collaborators and Investigators

• Sponsor: University of St. Augustine for Health Sciences
• Investigators: Principal Investigator: Miguel Garcia, EdD, University of St Augustine for Health Science

Study record dates

Study Major Dates

• Study Start (Anticipated): March 7, 2023
• Primary Completion (Anticipated): January 30, 2025
• Study Completion (Anticipated): April 30, 2026

Study Registration Dates

• First Submitted: October 22, 2022
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: PT-0401-498

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data obtained through this study may be provided to qualified researchers with academic interest in rehabilitation for individuals with Parkinson's Disease. Data or samples shared will be coded, with no Private Health Information included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• IPD Sharing Access Criteria: Access to trial Individual Patient Data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No