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Rock Steady Boxing: A Community Based In Person Class

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rock Steady Boxing Class
Sponsored by
University of St. Augustine for Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or Female Age Range: 18 years or older History of Parkinson's Disease between Hoehn and Yarh stages I and IV Medical clearance from a referring medical doctor Able to complete all assessments Willing to complete a weekly exercise log Exclusion Criteria: Unable to complete the assessments. Pregnant or is expected to become pregnant during study Other reasons that may limit participation in exercises. -

Sites / Locations

  • University of St Augustine for Health ScienceRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Rock Steady Boxing classes

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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
Changes in Parkinson's Disease Fatigue Scale from baseline to 1-year post
A patient-rated scale that measures fatigue
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.
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.
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.
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.
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.
Changes in Time Up and Go (TUG) from baseline to 1-year post
Measure of function with correlates to balance and fall risk
Changes in Self-Efficacy for Exercise from baseline to 1-year post
Self report measure of exercise self-efficacy
Changes in Anticipatory & Compensatory Postural Assessment form baseline to 1-year post
Electromyography measure of postural stability in standing
Changes in Rock Steady Boxing Questionnaire from 3-month post to 1-year post intervention
Self assessment of mobility and quality of life
Changes Physical Activity Intensity Monitoring from baseline to 1-year post intervention
Heart rate monitoring during exercise

Secondary Outcome Measures

Full Information

First Posted
October 22, 2022
Last Updated
March 6, 2023
Sponsor
University of St. Augustine for Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05773612
Brief Title
Rock Steady Boxing: A Community Based In Person Class
Official Title
Rock Steady Boxing: A Community Based In Person Class for Patients With Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2023 (Anticipated)
Primary Completion Date
January 30, 2025 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of St. Augustine for Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rock Steady Boxing classes
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Rock Steady Boxing Class
Intervention Description
Rock Steady Boxing is a non-contact fitness program designed specifically for people with Parkinson's Disease.
Primary Outcome Measure Information:
Title
Changes over time in Activities-Specific Balance Confidence Scale (ABC) from baseline to one year
Description
The ABC is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness.
Time Frame
Baseline, 3 months, 6-months and 1-year post intervention
Title
Changes in Falls Efficacy Scale - International from baseline to 1-year post
Description
A self-administered questionnaire designed to assess fear of falling in mainly community-dwelling older population
Time Frame
Baseline, 3 months, 6-months and 1-year post intervention
Title
Changes in Parkinson's Disease Fatigue Scale from baseline to 1-year post
Description
A patient-rated scale that measures fatigue
Time Frame
Baseline, 3 months, 6-months and 1-year post intervention
Title
Changes in Parkinson's Disease Questionnaire -39 from baseline to 1-year post
Description
A 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month.
Time Frame
Baseline, 3 months, 6-months and 1-year post intervention
Title
Changes in Physical Activity Scale for the Elderly (PASE) from baseline to 1-year post
Description
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.
Time Frame
Baseline, 3 months, 6-months and 1-year post intervention
Title
Changes in Berg Balance Test from baseline to 1-year post
Description
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.
Time Frame
Baseline, 3 months, 6-months and 1-year post intervention
Title
Changes in 10-Meter Walk Test from baseline to 1-year post
Description
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance.
Time Frame
Baseline, 3 months, 6-months and 1-year post intervention
Title
Changes in 6-Minute Walk Test from baseline to 1-year post
Description
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance.
Time Frame
Baseline, 3 months, 6-months and 1-year post intervention
Title
Changes in Time Up and Go (TUG) from baseline to 1-year post
Description
Measure of function with correlates to balance and fall risk
Time Frame
Baseline, 3 months, 6-months and 1-year post intervention
Title
Changes in Self-Efficacy for Exercise from baseline to 1-year post
Description
Self report measure of exercise self-efficacy
Time Frame
Baseline, 3 months, 6-months and 1-year post intervention
Title
Changes in Anticipatory & Compensatory Postural Assessment form baseline to 1-year post
Description
Electromyography measure of postural stability in standing
Time Frame
Baseline, 3 months, 6-months and 1-year post intervention
Title
Changes in Rock Steady Boxing Questionnaire from 3-month post to 1-year post intervention
Description
Self assessment of mobility and quality of life
Time Frame
3 months, 6-months and 1-year post intervention
Title
Changes Physical Activity Intensity Monitoring from baseline to 1-year post intervention
Description
Heart rate monitoring during exercise
Time Frame
Baseline, 3 months, 6-months and 1-year post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or Female Age Range: 18 years or older History of Parkinson's Disease between Hoehn and Yarh stages I and IV Medical clearance from a referring medical doctor Able to complete all assessments Willing to complete a weekly exercise log Exclusion Criteria: Unable to complete the assessments. Pregnant or is expected to become pregnant during study Other reasons that may limit participation in exercises. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miguel Garcia, EdD
Phone
786-725-4047
Ext
4147
Email
mgarcia@usa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tatiana Godoy Bobbio, PhD
Phone
786-725-4053
Ext
4153
Email
TBobbio@usa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Garcia, EdD
Organizational Affiliation
University of St Augustine for Health Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of St Augustine for Health Science
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel Somarriba, EdD
Phone
786-725-4045
Ext
4145
Email
gsomarriba@usa.edu
First Name & Middle Initial & Last Name & Degree
Miguel Garcia, EdD
Phone
786-725-4047
Ext
4147
Email
mgarcia@usa.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Rock Steady Boxing: A Community Based In Person Class

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