Sensory Attention Focused Exercise in Parkinson's Disease
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Parkinson's Disease |
Other: Sensory Attention Focused Exercise (SAFEx) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Sensory Attention Focused Exercise in Parkinson's Disease: A Randomized Double-Crossover Trial. |
- Unified Parkinson's Disease Rating Scale (UPDRS) III (motor score) [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]Assessment of patient's disease severity, completed by a blinded certified clinician.
- Timed up and go [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]Participants stand out of a chair, walk 3 meters, turn around and sit back down. This task is timed.
- 30 second chair stand [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]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). [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]Participants complete a self-report questionnaire, and rank how they are feeling.
- Grooved Pegboard [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]Participants must place and remove 25 pegs as fast as possible using a standard Grooved Pegboard. Participants are timed.
- Step Length [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]Measured using GAITRite software.
- Velocity [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]Assessed using GAITRite software.
- Step to Step Length Variability [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]Assessed using GAITRite software.
| Enrollment: | 76 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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. |
|
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 B received no treatment for 12 weeks, then received SAFEx for 12 weeks. |
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Ontario | |
| Sun Life Financial Movement Disorders Research and Rehabilitation Centre | |
| Waterloo, Ontario, Canada, N2L 3J4 | |
| Study Director: | Quincy J Almeida, Ph.D | Sun Life Financial Movement Disorders Research and Rehabilitation Centre |
More Information
Additional Information:
Publications:
| Responsible Party: | Dr. Quincy Almeida; Director of Sun Life Financial Movement Disorders Research and Rehabilitation Centre, Sun Life Financial Movement Disorders Research and Rehabilitation Centre; Wilfrid Laurier University |
| ClinicalTrials.gov Identifier: | NCT01246700 History of Changes |
| Other Study ID Numbers: | 225510 |
| Study First Received: | November 22, 2010 |
| Last Updated: | November 22, 2010 |
| Health Authority: | Canada: Wilfrid Laurier University Board of Ethics - REB |
Keywords provided by Sun Life Financial Movement Disorders Research and Rehabilitation Centre:
|
Parkinson's disease Randomized single-blind crossover trial Sensory Attention Focused Exercise |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 23, 2013