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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05773612
Other study ID # PT-0401-498
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 7, 2023
Est. completion date April 30, 2026

Study information

Verified date March 2023
Source University of St. Augustine for Health Sciences
Contact Miguel Garcia, EdD
Phone 786-725-4047
Email mgarcia@usa.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date April 30, 2026
Est. primary completion date January 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Rock Steady Boxing Class
Rock Steady Boxing is a non-contact fitness program designed specifically for people with Parkinson's Disease.

Locations

Country Name City State
United States University of St Augustine for Health Science Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
University of St. Augustine for Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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