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Parkinson's DiseaseNCT01246700

Sensory Attention Focused Exercise in Parkinson's Disease

A study testing Sensory Attention Focused Exercise (SAFEx) in people with Parkinson's Disease, run by Sun Life Financial Movement Disorders Research and Rehabilitation Centre at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Parkinson's Disease
What is being tested?
Sensory Attention Focused Exercise (SAFEx)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteCanada
Study dates
Jun 2008to Dec 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • diagnosis of PD by a clinician/neurologist
  • absence of mentation
  • established medication schedule and dosage

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Sun Life Financial Movement Disorders Research and Rehabilitation Centre

    Waterloo, Ontario, N2L 3J4

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Sensory Attention Focused Exercise (SAFEx)
Keywords
Parkinson's disease, Randomized single-blind crossover trial, Sensory Attention Focused Exercise
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sensory Attention Focused Exercise (SAFEx)Other

    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)Other

    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.

Study groups in NCT01246700
Study groupRoleWhat they receive
Group AExperimentalParticipants received 12 weeks of Sensory Attention Focused Exercise, then received 12 weeks of no exercise.
Receives: Other: Sensory Attention Focused Exercise (SAFEx)
Group BExperimentalParticipants received no treatment for 12 weeks, then received Sensory Attention Focused Exercise for 12 weeks.
Receives: Other: Sensory Attention Focused Exercise (SAFEx)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Unified Parkinson's Disease Rating Scale (UPDRS) III (motor score)

    Assessment of patient's disease severity, completed by a blinded certified clinician.

    Measured: Baseline, 12 weeks and 24 weeks

Secondary outcomes (7)

  1. Timed up and go

    Participants stand out of a chair, walk 3 meters, turn around and sit back down. This task is timed.

    Measured: Baseline, 12 weeks and 24 weeks

  2. 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.

    Measured: Baseline, 12 weeks and 24 weeks

  3. 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.

    Measured: Baseline, 12 weeks and 24 weeks

  4. Grooved Pegboard

    Participants must place and remove 25 pegs as fast as possible using a standard Grooved Pegboard. Participants are timed.

    Measured: Baseline, 12 weeks and 24 weeks

  5. Step Length

    Measured using GAITRite software.

    Measured: Baseline, 12 weeks and 24 weeks

  6. Velocity

    Assessed using GAITRite software.

    Measured: Baseline, 12 weeks and 24 weeks

  7. Step to Step Length Variability

    Assessed using GAITRite software.

    Measured: Baseline, 12 weeks and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2010 (estimated)
  2. Study startJun 2008
  3. Primary completionDec 2009
  4. Study completionDec 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01246700
Sponsor's protocol ID
225510
Status last verified
Sep 2010
First submitted
22 Nov 2010
Last updated
23 Nov 2010
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19373930

  • 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.

    PubMed 19938164

  • 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.

    PubMed 17229744

  • 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.

    PubMed 8145901

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

    PubMed 38588457

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PubMed 36602886

Questions about this trial

What is this clinical trial studying?

A study testing Sensory Attention Focused Exercise (SAFEx) in people with Parkinson's Disease, run by Sun Life Financial Movement Disorders Research and Rehabilitation Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unified Parkinson's Disease Rating Scale (UPDRS) III (motor score) (time frame: Baseline, 12 weeks and 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01246700, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2010.

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