Rock Steady Boxing vs. Sensory Attention Focused Exercise

• ClinicalTrials.gov Identifier: NCT03618901
• Recruitment Status: Unknown
• First Posted: August 7, 2018
• Last Update Posted: May 16, 2019
• Sponsor: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
• Information provided by (Responsible Party): Kishoree, Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Tracking Information

• First Submitted Date: July 18, 2018
• First Posted Date: August 7, 2018
• Last Update Posted Date: May 16, 2019
• Actual Study Start Date: September 30, 2018
• Estimated Primary Completion Date: July 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: 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.
• 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: Interventional
• Study Phase: Not Applicable

Study Design

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: Parkinson Disease

Intervention

• Other: Rock Steady Boxing
  Boxing programs as offered by the Rock Steady Boxing institution,
• Other: PD SAFEx
  Progressive proprioception training.

Study Arms

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 1, 2018): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 30, 2019
• Estimated Primary Completion Date: July 30, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03618901
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Kishoree, Sun Life Financial Movement Disorders Research and Rehabilitation Centre
• Original Responsible Party: Same as current
• Current Study Sponsor: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
• Verification Date: May 2019