Parkinson DiseaseNCT05773612
Rock Steady Boxing: A Community Based In Person Class
A study testing Rock Steady Boxing Class in people with Parkinson Disease, run by University of St. Augustine for Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Rock Steady Boxing Class
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to complete the assessments.
- Pregnant or is expected to become pregnant during study
- Other reasons that may limit participation in exercises. -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of St Augustine for Health Science
Miami, Florida, 33134
Gabriel Somarriba, EdD, 786-725-4045 ext. 4145, gsomarriba@usa.edu
Miguel Garcia, EdD, 786-725-4047 ext. 4147, mgarcia@usa.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Rock Steady Boxing Class
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rock Steady Boxing ClassOther
Rock Steady Boxing is a non-contact fitness program designed specifically for people with Parkinson's Disease.
| Study group | Role | What they receive |
|---|---|---|
| Rock Steady Boxing classes | Other | 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. Receives: Other: Rock Steady Boxing Class |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 3 months, 6-months and 1-year post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start7 Mar 2023 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of St. Augustine for Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miguel Garcia, EdD, Principal investigator, University of St Augustine for Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773612
- Sponsor's protocol ID
- PT-0401-498
- Status last verified
- Mar 2023
- First submitted
- 22 Oct 2022
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rock Steady Boxing: A Community Based In Person Class for Patients With Parkinson Disease
- ClinicalTrials.gov ID
- NCT05773612
- Acronym / sponsor ID
- PT-0401-498
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of St. Augustine for Health SciencesUniversity, hospital or other
- Study start
- 7 Mar 2023 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rock Steady Boxing classes | Other | Other: Rock Steady Boxing ClassThe 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to complete the assessments.
- Pregnant or is expected to become pregnant during study
- Other reasons that may limit participation in exercises. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rock Steady Boxing ClassRock Steady Boxing is a non-contact fitness program designed specifically for people with Parkinson's Disease. | Other | Rock Steady Boxing classes |
Primary outcome
Changes over time in Activities-Specific Balance Confidence Scale (ABC) from baseline to one year
Time frame: Baseline, 3 months, 6-months and 1-year post intervention
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
Time frame: Baseline, 3 months, 6-months and 1-year post intervention
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
Time frame: Baseline, 3 months, 6-months and 1-year post intervention
A patient-rated scale that measures fatigue
Changes in Parkinson's Disease Questionnaire -39 from baseline to 1-year post
Time frame: Baseline, 3 months, 6-months and 1-year post intervention
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
Time frame: Baseline, 3 months, 6-months and 1-year post intervention
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
Time frame: Baseline, 3 months, 6-months and 1-year post intervention
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
Time frame: Baseline, 3 months, 6-months and 1-year post intervention
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
Time frame: Baseline, 3 months, 6-months and 1-year post intervention
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
Time frame: Baseline, 3 months, 6-months and 1-year post intervention
Measure of function with correlates to balance and fall risk
Changes in Self-Efficacy for Exercise from baseline to 1-year post
Time frame: Baseline, 3 months, 6-months and 1-year post intervention
Self report measure of exercise self-efficacy
Changes in Anticipatory & Compensatory Postural Assessment form baseline to 1-year post
Time frame: Baseline, 3 months, 6-months and 1-year post intervention
Electromyography measure of postural stability in standing
Changes in Rock Steady Boxing Questionnaire from 3-month post to 1-year post intervention
Time frame: 3 months, 6-months and 1-year post intervention
Self assessment of mobility and quality of life
Changes Physical Activity Intensity Monitoring from baseline to 1-year post intervention
Time frame: Baseline, 3 months, 6-months and 1-year post intervention
Heart rate monitoring during exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Garcia, EdD principal investigator
University of St Augustine for Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rock Steady Boxing Class in people with Parkinson Disease, run by University of St. Augustine for Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miguel Garcia, EdD (786-725-4047 ext. 4147, mgarcia@usa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes over time in Activities-Specific Balance Confidence Scale (ABC) from baseline to one year (time frame: Baseline, 3 months, 6-months and 1-year post intervention). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.