Sensory Attention Focused Exercise in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01246700
• Other study ID #: 225510
• Status: Active, not recruiting
• Phase: N/A
• First received: November 22, 2010
• Last updated: November 22, 2010
• Start date: June 2008
• Est. completion date: December 2010

Study information

• Verified date: September 2010
• Source: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Wilfrid Laurier University Board of Ethics - REB
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Sun Life Financial Movement Disorders Research and Rehabilitation Centre	Waterloo	Ontario

Sponsors (5)

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

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View 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. Erratum in: J Neurol Neurosurg Psychiatry. 2010 Dec;81(12):1414. J Neurol Neurosurg Psychiatry. 2010 Jan;81(1):126. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unified Parkinson's Disease Rating Scale (UPDRS) III (motor score)	Assessment of patient's disease severity, completed by a blinded certified clinician.	Baseline, 12 weeks and 24 weeks	No
Secondary	Timed up and go	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	No
Secondary	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.	Baseline, 12 weeks and 24 weeks	No
Secondary	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.	Baseline, 12 weeks and 24 weeks	No
Secondary	Grooved Pegboard	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	No
Secondary	Step Length	Measured using GAITRite software.	Baseline, 12 weeks and 24 weeks	No
Secondary	Velocity	Assessed using GAITRite software.	Baseline, 12 weeks and 24 weeks	No
Secondary	Step to Step Length Variability	Assessed using GAITRite software.	Baseline, 12 weeks and 24 weeks	No

External Links

•   The Sun Life Movement Disorders Research and Rehabilitation Centre, based out of Wilfrid Laurier University, facilitates relevant research on Parkinson's disease.