Sensory Attention Focused Exercise in Parkinson's Disease

November 22, 2010 updated by: Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Sensory Attention Focused Exercise in Parkinson's Disease: A Randomized Double-Crossover Trial.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Waterloo, Ontario, Canada, N2L 3J4
        • Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Participants received 12 weeks of Sensory Attention Focused Exercise, then received 12 weeks of no exercise.
Other: Sensory Attention Focused Exercise (SAFEx)

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.

Other: Sensory Attention Focused Exercise (SAFEx)

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.
Experimental: Group B
Participants received no treatment for 12 weeks, then received Sensory Attention Focused Exercise for 12 weeks.
Other: Sensory Attention Focused Exercise (SAFEx)

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.

Other: Sensory Attention Focused Exercise (SAFEx)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS) III (motor score)
Time Frame: Baseline, 12 weeks and 24 weeks
Assessment of patient's disease severity, completed by a blinded certified clinician.
Baseline, 12 weeks and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed up and go
Time Frame: Baseline, 12 weeks and 24 weeks
Participants stand out of a chair, walk 3 meters, turn around and sit back down. This task is timed.
Baseline, 12 weeks and 24 weeks
30 second chair stand
Time Frame: Baseline, 12 weeks and 24 weeks
Participants instructed to stand from a seated position as many times as possible in 30 seconds. Number of completed stands is recorded.
Baseline, 12 weeks and 24 weeks
Unified Parkinson's Disease Rating Scale (UPDRS) - I and II (self report of mentation, depression, and activities of daily living).
Time Frame: Baseline, 12 weeks and 24 weeks
Participants complete a self-report questionnaire, and rank how they are feeling.
Baseline, 12 weeks and 24 weeks
Grooved Pegboard
Time Frame: Baseline, 12 weeks and 24 weeks
Participants must place and remove 25 pegs as fast as possible using a standard Grooved Pegboard. Participants are timed.
Baseline, 12 weeks and 24 weeks
Step Length
Time Frame: Baseline, 12 weeks and 24 weeks
Measured using GAITRite software.
Baseline, 12 weeks and 24 weeks
Velocity
Time Frame: Baseline, 12 weeks and 24 weeks
Assessed using GAITRite software.
Baseline, 12 weeks and 24 weeks
Step to Step Length Variability
Time Frame: Baseline, 12 weeks and 24 weeks
Assessed using GAITRite software.
Baseline, 12 weeks and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Collaborators

Canadian Institutes of Health Research (CIHR)
Parkinson Society Canada
Canada, Young Men's Christian Association (YMCA)
Canada, Sun Life Financial

Investigators

  • Study Director: Quincy J Almeida, Ph.D, Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

November 22, 2010

First Submitted That Met QC Criteria

November 22, 2010

First Posted (Estimate)

November 23, 2010

Study Record Updates

Last Update Posted (Estimate)

November 23, 2010

Last Update Submitted That Met QC Criteria

November 22, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 225510

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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