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Rock Steady Boxing vs. Sensory Attention Focused Exercise

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Rock Steady Boxing
PD SAFEx
Sponsored by
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease

Eligibility Criteria

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

Inclusion Criteria:

  • must be able to understand verbal instructions in English
  • diagnosed with idiopathic PD by a neurologist

Exclusion Criteria:

  • if diagnosed with a neurological condition other than PD
  • if participated in an exercise program at least 2-weeks prior to the start of the study

Sites / Locations

  • Movement Disorders Research and Rehabilitation CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rock Steady Boxing

PD SAFEx

Arm Description

Non-contact boxing program.

Sensory attention focused exercise.

Outcomes

Primary Outcome Measures

Motor symptom improvements
Unified Parkinson Disease Rating Scale (UPDRS) conducted by a qualified movement disorders specialist. The maximum score is 108, the higher the score, the worse the symptoms.

Secondary Outcome Measures

Quality of life assessments
Completion of Parkinson's Disease Questionnaire (PDQ-39). There are 8 sections: mobility (sub score 10), activities of daily living (sub score 6), emotional well-being (sub score 6), stigma (sub score 4), social support (sub score 3), cognition (sub score 4), communication (sub score 3) and bodily discomfort (sub score 3). The higher the score, the worse the symptoms.
Balance1
Using the Biodex balance system. The postural stability test (PST) will be conducted. The results will be presented as actual score and standard deviation for both legs to determine an individuals ability to maintain balance. The lower the score the better.
Gait1
For the timed-up-and-go test (TUG) participants will stand up, walk to the line on the floor, turn around and walk back to the chair and sit down.
Strength
Will be assessed using the Jamar hand dynamometer.
Cognitive Assessment 1
Scale of Outcomes of Parkinson Disease (SCOPA-COG), will be used to assess memory and visuospatial function. There are 5 sections: memory learning, attention, executive functions, visuo-spatial functions and memory. The total score that can be achieved is 43 (the higher the score the better).
cognitive assessment 3
Completion of Montreal Cognitive Assessment (MoCA). There are a total 30 points, the higher the score the better (26 and above is normal).
Balance 2
Activities-specific Balance Confidence Scale (ABC). The total score that can be achieved is 16, the higher the percent the more self-confidence.
Cognitive assessment 2
Mini-Mental State Examination (MMSE). The total score than can be achieved is otal score 30 (the higher the score the better).

Full Information

First Posted
July 18, 2018
Last Updated
May 14, 2019
Sponsor
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03618901
Brief Title
Rock Steady Boxing vs. Sensory Attention Focused Exercise
Official Title
A Randomized Crossover Trial: The Effects of Rock Steady Boxing vs. Sensory Attention Focused Exercise on Disease Progression for Those With Parkinson's Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Anticipated)
Study Completion Date
August 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Life Financial Movement Disorders Research and Rehabilitation Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the effect on Rock Steady Boxing (RSB) and PD SAFEx on Parkinson's disease.
Detailed Description
Both interventions produce benefits to the PD population. PD SAFEx has been proven to improve the motor symptoms of PD. However, research still needs to be conducted on the PD specific benefits associated with RSB. As such it an RCT is necessary to compare the effects of both interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The early start group: 12-weeks (intervention) followed by 12-weeks of no exercise. The delayed start group: 12-weeks (no exercise) followed by 12-weeks (intervention). This model will be used for both RSB and PD SAFEx.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rock Steady Boxing
Arm Type
Experimental
Arm Description
Non-contact boxing program.
Arm Title
PD SAFEx
Arm Type
Active Comparator
Arm Description
Sensory attention focused exercise.
Intervention Type
Other
Intervention Name(s)
Rock Steady Boxing
Intervention Description
Boxing programs as offered by the Rock Steady Boxing institution,
Intervention Type
Other
Intervention Name(s)
PD SAFEx
Intervention Description
Progressive proprioception training.
Primary Outcome Measure Information:
Title
Motor symptom improvements
Description
Unified Parkinson Disease Rating Scale (UPDRS) conducted by a qualified movement disorders specialist. The maximum score is 108, the higher the score, the worse the symptoms.
Time Frame
change from baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Quality of life assessments
Description
Completion of Parkinson's Disease Questionnaire (PDQ-39). There are 8 sections: mobility (sub score 10), activities of daily living (sub score 6), emotional well-being (sub score 6), stigma (sub score 4), social support (sub score 3), cognition (sub score 4), communication (sub score 3) and bodily discomfort (sub score 3). The higher the score, the worse the symptoms.
Time Frame
change from baseline at 12 weeks
Title
Balance1
Description
Using the Biodex balance system. The postural stability test (PST) will be conducted. The results will be presented as actual score and standard deviation for both legs to determine an individuals ability to maintain balance. The lower the score the better.
Time Frame
change from baseline at 12 weeks
Title
Gait1
Description
For the timed-up-and-go test (TUG) participants will stand up, walk to the line on the floor, turn around and walk back to the chair and sit down.
Time Frame
change from baseline at 12 weeks
Title
Strength
Description
Will be assessed using the Jamar hand dynamometer.
Time Frame
change from baseline at 12 weeks
Title
Cognitive Assessment 1
Description
Scale of Outcomes of Parkinson Disease (SCOPA-COG), will be used to assess memory and visuospatial function. There are 5 sections: memory learning, attention, executive functions, visuo-spatial functions and memory. The total score that can be achieved is 43 (the higher the score the better).
Time Frame
change from baseline at 12 weeks
Title
cognitive assessment 3
Description
Completion of Montreal Cognitive Assessment (MoCA). There are a total 30 points, the higher the score the better (26 and above is normal).
Time Frame
change from baseline at 12 weeks
Title
Balance 2
Description
Activities-specific Balance Confidence Scale (ABC). The total score that can be achieved is 16, the higher the percent the more self-confidence.
Time Frame
change from baseline at 12 weeks
Title
Cognitive assessment 2
Description
Mini-Mental State Examination (MMSE). The total score than can be achieved is otal score 30 (the higher the score the better).
Time Frame
change from baseline at 12 weeks
Other Pre-specified Outcome Measures:
Title
Balance3
Description
Balance will be measured using the mini- Balance Evaluation Systems Test (mini-best test). There are 4 sections: anticipatory, (sub score 6) reactive postural control (sub score 6), sensory orientation (sub score 6), dynamic gait (sub score 10). The total score that can be achieved is 28. The higher the score the better the balance.
Time Frame
change from baseline at 12 weeks
Title
Physical activity
Description
Community Healthy Activities Model Program for Seniors (CHAMPS) is a questionnaire used to assess the weekly frequency and duration of the physical activities of seniors.
Time Frame
change from baseline at 12 weeks
Title
Gait 2
Description
For the 6-minute walking test (6MWT) participants will be asked to walk as far as possible for 6 minutes. The further (more laps) they are able to walk the better.
Time Frame
change from baseline at 12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: must be able to understand verbal instructions in English diagnosed with idiopathic PD by a neurologist Exclusion Criteria: if diagnosed with a neurological condition other than PD if participated in an exercise program at least 2-weeks prior to the start of the study
Facility Information:
Facility Name
Movement Disorders Research and Rehabilitation Centre
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3J4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kishoree Sangarapillai, Msc
Phone
5198840710
Ext
3924
Email
sang3490@mylaurier.ca
First Name & Middle Initial & Last Name & Degree
Quincy Almeida, PhD
Phone
5198840710
Ext
3924
Email
qalmeida@wlu.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Rock Steady Boxing vs. Sensory Attention Focused Exercise

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