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Non-contact Boxing Training and Traditional Therapeutic Exercise for Persons With Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional Therapeutic Exercise
Non-Contact Boxing Training
Sponsored by
University of Indianapolis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, exercise, training program, rehabilitation, boxing

Eligibility Criteria

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

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

Sites / Locations

  • University of Indianapolis, Krannert School of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Therapeutic Exercise

Non-Contact Boxing Training

Arm Description

Outcomes

Primary Outcome Measures

Mobility: Measured with the Timed Up and Go Test; Four-Square Step Test; Six-Minute Walk Test; Berg Balance Scale; Functional Reach Test

Secondary Outcome Measures

Participation: measured with the Activities Specific Balance Confidence Scale and the Parkinson's disease Quality of Life Scale

Full Information

First Posted
November 13, 2009
Last Updated
March 31, 2020
Sponsor
University of Indianapolis
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1. Study Identification

Unique Protocol Identification Number
NCT01014663
Brief Title
Non-contact Boxing Training and Traditional Therapeutic Exercise for Persons With Parkinson's Disease
Official Title
Comparison of Non-contact Boxing Training and Traditional Therapeutic Exercise on Functional Outcomes in Persons With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Indianapolis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study is to compare the effects of a non-traditional boxing training program to a traditional therapeutic exercise program on activity and participation outcomes in persons with Parkinson's disease. Thirty participants will be randomly assigned to participate in either non-contact boxing training or traditional therapeutic exercise for 36 sessions over 12 weeks. Participants will be measured immediately before (pre-test) and after (post-test) the intervention.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, exercise, training program, rehabilitation, boxing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Exercise
Arm Type
Active Comparator
Arm Title
Non-Contact Boxing Training
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Traditional Therapeutic Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Non-Contact Boxing Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Secondary Outcome Measure Information:
Title
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie A Combs, PT, PhD, NCS
Organizational Affiliation
University of Indianapolis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dyer M Diehl, PT, PhD
Organizational Affiliation
University of Indianapolis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William H Staples, PT, DPT, GCS
Organizational Affiliation
University of Indianapolis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Indianapolis, Krannert School of Physical Therapy
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States

12. IPD Sharing Statement

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Non-contact Boxing Training and Traditional Therapeutic Exercise for Persons With Parkinson's Disease

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