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Sensory Attention Focused Exercise in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sensory Attention Focused Exercise (SAFEx)
Sensory Attention Focused Exercise (SAFEx)
Sponsored by
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Randomized single-blind crossover trial, Sensory Attention Focused Exercise

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of PD by a clinician/neurologist
  • absence of mentation
  • established medication schedule and dosage

Exclusion Criteria:

  • mentation
  • change in medication during period of study
  • change in exercise level during period of study
  • inability to complete the exercise program
  • absence of 5 or more classes, or absence of 3 or more classes in sequence

Sites / Locations

  • Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

Participants received 12 weeks of Sensory Attention Focused Exercise, then received 12 weeks of no exercise.

Participants received no treatment for 12 weeks, then received Sensory Attention Focused Exercise for 12 weeks.

Outcomes

Primary Outcome Measures

Unified Parkinson's Disease Rating Scale (UPDRS) III (motor score)
Assessment of patient's disease severity, completed by a blinded certified clinician.

Secondary Outcome Measures

Timed up and go
Participants stand out of a chair, walk 3 meters, turn around and sit back down. This task is timed.
30 second chair stand
Participants instructed to stand from a seated position as many times as possible in 30 seconds. Number of completed stands is recorded.
Unified Parkinson's Disease Rating Scale (UPDRS) - I and II (self report of mentation, depression, and activities of daily living).
Participants complete a self-report questionnaire, and rank how they are feeling.
Grooved Pegboard
Participants must place and remove 25 pegs as fast as possible using a standard Grooved Pegboard. Participants are timed.
Step Length
Measured using GAITRite software.
Velocity
Assessed using GAITRite software.
Step to Step Length Variability
Assessed using GAITRite software.

Full Information

First Posted
November 22, 2010
Last Updated
November 22, 2010
Sponsor
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Collaborators
Canada, Young Men's Christian Association (YMCA), Parkinson Society Canada, Canada, Sun Life Financial, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01246700
Brief Title
Sensory Attention Focused Exercise in Parkinson's Disease
Official Title
Sensory Attention Focused Exercise in Parkinson's Disease: A Randomized Double-Crossover Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Collaborators
Canada, Young Men's Christian Association (YMCA), Parkinson Society Canada, Canada, Sun Life Financial, Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is 1.) to determine if sensory attention focused exercise is an effective management strategy for Parkinson's disease, and 2.) to identify if the benefits are a result of strength gains.
Detailed Description
Currently, there is no cure for Parkinson's disease (PD) and although medication offers symptom reduction, there are many negative side effects associated with medication use. Thus, there has been an increased emphasis on exercise interventions for symptom reduction. Recent research has shown that both sensory attention focused exercise (SAFEx) and strength training interventions improved disease severity more so than other exercise interventions (such as aerobic, aquatic and no exercise). Upon closer examination, SAFEx showed further symptom improvements than the strength training program. Thus exists the need to further examine SAFEx using a standardized protocol - a single-blind randomized double-crossover trial - that has been used sparingly in exercise interventions. In addition, the 30-second chair stand has been implemented into the testing protocol, as it has been shown to be a reliable measurement of functional strength for older adults. This test was implemented in order to identify the functional strength gains, if any, that are associated with SAFEx. It is hypothesized that the SAFEx intervention will improve disease symptoms in PD, and that the results will not be due to strength gains.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Randomized single-blind crossover trial, Sensory Attention Focused Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Participants received 12 weeks of Sensory Attention Focused Exercise, then received 12 weeks of no exercise.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Participants received no treatment for 12 weeks, then received Sensory Attention Focused Exercise for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Sensory Attention Focused Exercise (SAFEx)
Intervention Description
Consisted of 12 weeks for SAFEx intervention, 3 times a week for an hour each session. Participants complete dynamic balance activities and a variety of seated stretches and range of motion activities. Participants are cued to focus on sensation and proprioception of limbs. Group A received SAFEx for 12 weeks then received no treatment for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Sensory Attention Focused Exercise (SAFEx)
Intervention Description
Consisted of 12 weeks for SAFEx intervention, 3 times a week for an hour each session. Participants complete dynamic balance activities and a variety of seated stretches and range of motion activities. Participants are cued to focus on sensation and proprioception of limbs. Group B received no treatment for 12 weeks, then received SAFEx for 12 weeks.
Primary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS) III (motor score)
Description
Assessment of patient's disease severity, completed by a blinded certified clinician.
Time Frame
Baseline, 12 weeks and 24 weeks
Secondary Outcome Measure Information:
Title
Timed up and go
Description
Participants stand out of a chair, walk 3 meters, turn around and sit back down. This task is timed.
Time Frame
Baseline, 12 weeks and 24 weeks
Title
30 second chair stand
Description
Participants instructed to stand from a seated position as many times as possible in 30 seconds. Number of completed stands is recorded.
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Unified Parkinson's Disease Rating Scale (UPDRS) - I and II (self report of mentation, depression, and activities of daily living).
Description
Participants complete a self-report questionnaire, and rank how they are feeling.
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Grooved Pegboard
Description
Participants must place and remove 25 pegs as fast as possible using a standard Grooved Pegboard. Participants are timed.
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Step Length
Description
Measured using GAITRite software.
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Velocity
Description
Assessed using GAITRite software.
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Step to Step Length Variability
Description
Assessed using GAITRite software.
Time Frame
Baseline, 12 weeks and 24 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of PD by a clinician/neurologist absence of mentation established medication schedule and dosage Exclusion Criteria: mentation change in medication during period of study change in exercise level during period of study inability to complete the exercise program absence of 5 or more classes, or absence of 3 or more classes in sequence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quincy J Almeida, Ph.D
Organizational Affiliation
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Official's Role
Study Director
Facility Information:
Facility Name
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3J4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19373930
Citation
Sage MD, Almeida QJ. Symptom and gait changes after sensory attention focused exercise vs aerobic training in Parkinson's disease. Mov Disord. 2009 Jun 15;24(8):1132-8. doi: 10.1002/mds.22469.
Results Reference
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PubMed Identifier
19938164
Citation
Sage MD, Almeida QJ. A positive influence of vision on motor symptoms during sensory attention focused exercise for Parkinson's disease. Mov Disord. 2010 Jan 15;25(1):64-9. doi: 10.1002/mds.22886.
Results Reference
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PubMed Identifier
17229744
Citation
Nieuwboer A, Kwakkel G, Rochester L, Jones D, van Wegen E, Willems AM, Chavret F, Hetherington V, Baker K, Lim I. Cueing training in the home improves gait-related mobility in Parkinson's disease: the RESCUE trial. J Neurol Neurosurg Psychiatry. 2007 Feb;78(2):134-40. doi: 10.1136/jnnp.200X.097923. Erratum In: J Neurol Neurosurg Psychiatry. 2010 Dec;81(12):1414. J Neurol Neurosurg Psychiatry. 2010 Jan;81(1):126.
Results Reference
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PubMed Identifier
8145901
Citation
Comella CL, Stebbins GT, Brown-Toms N, Goetz CG. Physical therapy and Parkinson's disease: a controlled clinical trial. Neurology. 1994 Mar;44(3 Pt 1):376-8. doi: 10.1212/wnl.44.3_part_1.376.
Results Reference
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Sensory Attention Focused Exercise in Parkinson's Disease

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