Clinical trial NCT01246700: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Randomized single-blind crossover trial
Sensory Attention Focused Exercise
Lead sponsor: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Sponsor class: OTHER
Collaborators: name: Canada, Young Men's Christian Association (YMCA)
name: Parkinson Society Canada
name: Canada, Sun Life Financial
name: Canadian Institutes of Health Research (CIHR)
First posted: 2010-11-23
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) III (motor score)
timeFrame: Baseline, 12 weeks and 24 weeks
Secondary outcomes:
measure: Timed up and go
timeFrame: Baseline, 12 weeks and 24 weeks
measure: 30 second chair stand
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Unified Parkinson's Disease Rating Scale (UPDRS) - I and II (self report of mentation, depression, and activities of daily living).
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Grooved Pegboard
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Step Length
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Velocity
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Step to Step Length Variability
timeFrame: Baseline, 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
state: Ontario
Study officials:
affiliation: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
name: Quincy J Almeida, Ph.D
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.