- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01014663
Non-contact Boxing Training and Traditional Therapeutic Exercise for Persons With Parkinson's Disease
Comparison of Non-contact Boxing Training and Traditional Therapeutic Exercise on Functional Outcomes in Persons With Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Physical therapists commonly treat patients with Parkinson's disease. Typical clinical interventions used by physical therapists including strengthening, stretching and aerobic training have been shown to improve function and quality of life of persons with Parkinson's disease. Alternative exercise interventions that incorporate non-traditional concepts, such as tango dance, tai chi and taiji have also been found to lead to improvements in function in persons with Parkinson's disease. It is important that comparisons between different types of exercise programs for persons with Parkinson's disease be explored in order to determine effective options for care.
Here in Indianapolis, Indiana, individuals with Parkinson's disease have a unique opportunity for alternative exercise with the recent development of the popular non-contact boxing training program offered by the Rock Steady Boxing Foundation. Therefore, the purpose of this study is to compare the effects of the non-traditional boxing training program to a traditional therapeutic exercise program on activity and participation outcomes in persons with Parkinson's disease.
Thirty participants with Parkinson's disease will be recruited from Central Indiana. All potential participants will be screened to determine eligibility for the study. Participants who are eligible and give consent will be randomly assigned to participate in either the non-contact boxing training or the traditional therapeutic exercise program for 36 sessions lasting over 12 weeks with 60-90 minutes of exercise each session. Participants will be measured immediately before (pre-test) and after (post-test) the intervention period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
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Indianapolis, Indiana, United States, 46227
- University of Indianapolis, Krannert School of Physical Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of Parkinson's disease
- currently not receiving physical therapy services
- medically stable with a physician release stating approval to enter an exercise program
- independently ambulatory in the home setting with or without the use of an assistive device
- able to follow at least three step verbal commands
- available for the entire period of the study
- have transportation to and from training and measurement sessions
Exclusion Criteria:
- preexisting neurological conditions other than Parkinson's disease
- current musculoskeletal conditions that would limit participation in either training program
- significant orthopedic surgery within the past six months
- past brain surgery or brain stimulator implant
- currently known pregnant
- pre-existing cardiovascular conditioner that would prohibit participation in an exercise program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Therapeutic Exercise
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The therapeutic exercise program will consist of warm-up and stretching, seated and standing range of motion activities, endurance and resistance training, balance training and a cool down.
Training will take place for 36 sessions, three times/week for 60-90 minutes per session.
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Active Comparator: Non-Contact Boxing Training
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Non-contact boxing training will consist of warm-up and stretching, non-contact boxing training (including punching a focus mitt, speed and heavy punching bags), endurance training activities, strength and resistance training, and a cool down.
Training will take place for 36 sessions, three times/week for 60-90 minutes per session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mobility: Measured with the Timed Up and Go Test; Four-Square Step Test; Six-Minute Walk Test; Berg Balance Scale; Functional Reach Test
Time Frame: Each outcome measures is assessed at pre-test (immediately before intervention), post-test (immediately after the 12 week intervention).
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Each outcome measures is assessed at pre-test (immediately before intervention), post-test (immediately after the 12 week intervention).
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Participation: measured with the Activities Specific Balance Confidence Scale and the Parkinson's disease Quality of Life Scale
Time Frame: Each outcome measures is assessed at pre-test (immediately before intervention), post-test (immediately after the 12 week intervention).
|
Each outcome measures is assessed at pre-test (immediately before intervention), post-test (immediately after the 12 week intervention).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephanie A Combs, PT, PhD, NCS, University of Indianapolis
- Principal Investigator: Dyer M Diehl, PT, PhD, University of Indianapolis
- Principal Investigator: William H Staples, PT, DPT, GCS, University of Indianapolis
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EXB-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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