Rock Steady Boxing vs. Sensory Attention Focused Exercise

Sponsor
Sun Life Financial Movement Disorders Research and Rehabilitation Centre (Other)
Overall Status
Unknown status
CT.gov ID
NCT03618901
Collaborator
(none)
60
1
2
11
5.5

Study Details

Study Description

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
  • Other: Rock Steady Boxing
  • Other: PD SAFEx
N/A

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 Design

Study Type:
Interventional
Anticipated 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.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 :
Sep 30, 2018
Anticipated Primary Completion Date :
Jul 30, 2019
Anticipated Study Completion Date :
Aug 30, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Motor symptom improvements [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 [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 [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 [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 [change from baseline at 12 weeks]

    Will be assessed using the Jamar hand dynamometer.

  5. Cognitive Assessment 1 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Movement Disorders Research and Rehabilitation Centre Waterloo Ontario Canada N2L 3J4

Sponsors and Collaborators

  • Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Aug 7, 2018
Last Update Posted:
May 16, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 16, 2019