Clinical trial NCT05773612: 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
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of St. Augustine for Health Sciences
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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. -

Primary outcomes:
measure: Changes over time in Activities-Specific Balance Confidence Scale (ABC) from baseline to one year
timeFrame: Baseline, 3 months, 6-months and 1-year post intervention
measure: Changes in Falls Efficacy Scale - International from baseline to 1-year post
timeFrame: Baseline, 3 months, 6-months and 1-year post intervention
measure: Changes in Parkinson's Disease Fatigue Scale from baseline to 1-year post
timeFrame: Baseline, 3 months, 6-months and 1-year post intervention
measure: Changes in Parkinson's Disease Questionnaire -39 from baseline to 1-year post
timeFrame: Baseline, 3 months, 6-months and 1-year post intervention
measure: Changes in Physical Activity Scale for the Elderly (PASE) from baseline to 1-year post
timeFrame: Baseline, 3 months, 6-months and 1-year post intervention
measure: Changes in Berg Balance Test from baseline to 1-year post
timeFrame: Baseline, 3 months, 6-months and 1-year post intervention
measure: Changes in 10-Meter Walk Test from baseline to 1-year post
timeFrame: Baseline, 3 months, 6-months and 1-year post intervention
measure: Changes in 6-Minute Walk Test from baseline to 1-year post
timeFrame: Baseline, 3 months, 6-months and 1-year post intervention
measure: Changes in Time Up and Go (TUG) from baseline to 1-year post
timeFrame: Baseline, 3 months, 6-months and 1-year post intervention
measure: Changes in Self-Efficacy for Exercise from baseline to 1-year post
timeFrame: Baseline, 3 months, 6-months and 1-year post intervention
measure: Changes in Anticipatory & Compensatory Postural Assessment form baseline to 1-year post
timeFrame: Baseline, 3 months, 6-months and 1-year post intervention
measure: Changes in Rock Steady Boxing Questionnaire from 3-month post to 1-year post intervention
timeFrame: 3 months, 6-months and 1-year post intervention
measure: Changes Physical Activity Intensity Monitoring from baseline to 1-year post intervention
timeFrame: Baseline, 3 months, 6-months and 1-year post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of St Augustine for Health Science
state: Florida
Study officials:
affiliation: University of St Augustine for Health Science
name: Miguel Garcia, EdD
role: PRINCIPAL_INVESTIGATOR
References: