Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rock Steady Boxing vs. Sensory Attention Focused Exercise

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03618901
Recruitment Status : Recruiting
First Posted : August 7, 2018
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Kishoree, Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Tracking Information
First Submitted Date  ICMJE July 18, 2018
First Posted Date  ICMJE August 7, 2018
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE September 30, 2018
Estimated Primary Completion Date July 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
Motor symptom improvements [ Time Frame: change from baseline at 12 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • Quality of life assessments [ Time Frame: change from baseline at 12 weeks ]
    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 [ Time Frame: change from baseline at 12 weeks ]
    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 [ Time Frame: change from baseline at 12 weeks ]
    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 [ Time Frame: change from baseline at 12 weeks ]
    Will be assessed using the Jamar hand dynamometer.
  • Cognitive Assessment 1 [ Time Frame: change from baseline at 12 weeks ]
    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 [ Time Frame: change from baseline at 12 weeks ]
    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 [ Time Frame: change from baseline at 12 weeks ]
    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 [ Time Frame: change from baseline at 12 weeks ]
    Mini-Mental State Examination (MMSE). The total score than can be achieved is otal score 30 (the higher the score the better).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 1, 2018)
  • Balance3 [ Time Frame: change from baseline at 12 weeks ]
    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.
  • Physical activity [ Time Frame: change from baseline at 12 weeks ]
    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.
  • Gait 2 [ Time Frame: change from baseline at 12 weeks ]
    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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Rock Steady Boxing vs. Sensory Attention Focused Exercise
Official Title  ICMJE A Randomized Crossover Trial: The Effects of Rock Steady Boxing vs. Sensory Attention Focused Exercise on Disease Progression for Those With Parkinson's Disease.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Other: Rock Steady Boxing
    Boxing programs as offered by the Rock Steady Boxing institution,
  • Other: PD SAFEx
    Progressive proprioception training.
Study Arms  ICMJE
  • Experimental: Rock Steady Boxing
    Non-contact boxing program.
    Intervention: Other: Rock Steady Boxing
  • Active Comparator: PD SAFEx
    Sensory attention focused exercise.
    Intervention: Other: PD SAFEx
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2019
Estimated Primary Completion Date July 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03618901
Other Study ID Numbers  ICMJE MDRC2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kishoree, Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Study Sponsor  ICMJE Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP