Overview

This trial is active, not recruiting.

Condition parkinson's disease
Treatments sensory attention focused exercise (safex)
Sponsor Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Collaborator Canada, Young Men's Christian Association (YMCA)
Start date June 2008
End date December 2009
Trial size 76 participants
Trial identifier NCT01246700, 225510

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants received 12 weeks of Sensory Attention Focused Exercise, then received 12 weeks of no exercise.
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.
(Experimental)
Participants received no treatment for 12 weeks, then received Sensory Attention Focused Exercise 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.

Primary Outcomes

Measure
Unified Parkinson's Disease Rating Scale (UPDRS) III (motor score)
time frame: Baseline, 12 weeks and 24 weeks

Secondary Outcomes

Measure
Timed up and go
time frame: Baseline, 12 weeks and 24 weeks
30 second chair stand
time frame: 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
Grooved Pegboard
time frame: Baseline, 12 weeks and 24 weeks
Step Length
time frame: Baseline, 12 weeks and 24 weeks
Velocity
time frame: Baseline, 12 weeks and 24 weeks
Step to Step Length Variability
time frame: Baseline, 12 weeks and 24 weeks

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Sensory Attention Focused Exercise in Parkinson's Disease: A Randomized Double-Crossover Trial.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2010.
Information provided to ClinicalTrials.gov by Sun Life Financial Movement Disorders Research and Rehabilitation Centre.