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Trial record 3 of 4443 for:    ROCK

Rock Steady Boxing vs. Sensory Attention Focused Exercise

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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

Brief Summary:
This study evaluates the effect on Rock Steady Boxing (RSB) and PD SAFEx on Parkinson's disease.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Rock Steady Boxing Other: PD SAFEx Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
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.
Actual Study Start Date : September 30, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rock Steady Boxing
Non-contact boxing program.
Other: Rock Steady Boxing
Boxing programs as offered by the Rock Steady Boxing institution,

Active Comparator: PD SAFEx
Sensory attention focused exercise.
Other: PD SAFEx
Progressive proprioception training.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Strength [ Time Frame: change from baseline at 12 weeks ]
    Will be assessed using the Jamar hand dynamometer.

  5. 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).

  6. 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).

  7. 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.

  8. 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).


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618901


Locations
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Canada, Ontario
Movement Disorders Research and Rehabilitation Centre Recruiting
Waterloo, Ontario, Canada, N2L 3J4
Contact: Kishoree Sangarapillai, Msc    5198840710 ext 3924    sang3490@mylaurier.ca   
Contact: Quincy Almeida, PhD    5198840710 ext 3924    qalmeida@wlu.ca   
Sponsors and Collaborators
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
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Responsible Party: Kishoree, Graduate Student, Sun Life Financial Movement Disorders Research and Rehabilitation Centre
ClinicalTrials.gov Identifier: NCT03618901    
Other Study ID Numbers: MDRC2
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases