Rock Steady Boxing vs. Sensory Attention Focused Exercise

A Randomized Crossover Trial: The Effects of Rock Steady Boxing vs. Sensory Attention Focused Exercise on Disease Progression for Those With Parkinson's Disease.

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

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Rock Steady Boxing; Other: PD SAFEx

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
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3J4
      • Recruiting
      • Movement Disorders Research and Rehabilitation Centre
      • Contact: Kishoree Sangarapillai, Msc; Phone Number: 3924 5198840710; Email: sang3490@mylaurier.ca
      • Contact: Quincy Almeida, PhD; Phone Number: 3924 5198840710; Email: qalmeida@wlu.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	change from baseline at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	change from baseline at 12 weeks
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.	change from baseline at 12 weeks
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.	change from baseline at 12 weeks
Strength	Will be assessed using the Jamar hand dynamometer.	change from baseline at 12 weeks
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).	change from baseline at 12 weeks
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).	change from baseline at 12 weeks
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.	change from baseline at 12 weeks
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).	change from baseline at 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance3	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.	change from baseline at 12 weeks
Physical activity	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.	change from baseline at 12 weeks
Gait 2	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.	change from baseline at 12 weeks

Collaborators and Investigators

• Sponsor: Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2018
• Primary Completion (Anticipated): July 30, 2019
• Study Completion (Anticipated): August 30, 2019

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 7, 2018

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: MDRC2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No