NCT02476240

Brief Summary

The purpose of this study is to evaluate the underlying mechanism and influence of externally vs. internally focused exercise on rehabilitation in Parkinson's disease. The upcoming exercise intervention methodology will aim to meet the requirements of a 1A silver ranking level, single blind, randomized control trial according to the criterion of the Cochrane Musculoskeletal Review Group

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 19, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

9 months

First QC Date

June 16, 2015

Last Update Submit

August 30, 2017

Conditions

Parkinson's Disease

Keywords

ExerciseAttention

Outcome Measures

Primary Outcomes (6)

  • Unified Parkinson's disease Rating Scale Part III (UPDRS-III)

    A physical movement assessment to quantify Parkinson's disease symptom severity. This is a non-invasive, risk free, painless examination.

    Pre-assessment to post-assessment (12 weeks)

  • UPDRS-III

    A physical movement assessment to quantify Parkinson's disease symptom severity. This is a non-invasive, risk free, painless examination.

    Post-assessment to Washout (8 weeks)

  • Single and Dual Task Walking

    Participants will be asked to walk along a 9.75m long and 0.61m wide ProtoKinetics Movement Analysis Software™ electronic walkway carpet (Zeno Walkway - ProtoKinetics, Havertown, PA, USA). This electronic walkway will measure spatiotemporal characteristics of the individuals' gait while they walk with and without the performance of a dual task. The dual task that will be performed by the participants with Parkinson's disease will be a phoneme monitoring dual task not trained in the intervention. Participants will be asked to complete 3 trials of each condition.

    Pre-assessment to Post-assessment (12 weeks)

  • Single Task and Dual Task Walking

    Participants will be asked to walk along a 9.75m long and 0.61m wide ProtoKinetics Movement Analysis Software™ electronic walkway carpet (Zeno Walkway - ProtoKinetics, Havertown, PA, USA). This electronic walkway will measure spatiotemporal characteristics of the individuals' gait while they walk with and without the performance of a dual task. The dual task that will be performed by the participants with Parkinson's disease will be a phoneme monitoring dual task not trained in the intervention. Participants will be asked to complete 3 trials of each condition.

    Post-assessment to washout (8 weeks)

  • Parkinson Anxiety Scale Questionnaire

    Valid measure of persistent, episodic, and avoidance behaviour anxiety

    Pre-assessment to Post-assessment (12 weeks)

  • Parkinson Anxiety Scale Questionnaire

    Valid measure of persistent, episodic, and avoidance behaviour anxiety

    Post-assessment to washout (8 weeks)

Secondary Outcomes (6)

  • Measures of Executive Function

    Pre-assessment to post-assessment (12 weeks)

  • Measures of Executive Function

    Post-assessment to Washout (8 weeks)

  • Parkinson's disease Questionnaire 39

    Pre-assessment to Post-assessment (12 weeks)

  • Parkinson's disease Questionnaire 39

    Post-assessment to washout (8 weeks)

  • Community Health Activities Model Program for Seniors questionnaire (CHAMPS)

    Pre-assessment to post-assessment (12 weeks)

  • +1 more secondary outcomes

Study Arms (3)

Internally Focused PD-SAFEx

ACTIVE COMPARATOR

While performing the exercises in PD-SAFEx™, participants will be instructed to focus their attention on sensory feedback. This will include focusing participants' attention on the stretch in their limbs while walking, on the straightness of their backs while sitting, on limb and body orientation in space while coordinating their movements, and on chest movements during breathing exercises. Throughout each exercise session, the instructor and volunteers will constantly provide attention-directing instructions.

Behavioral: Parkinson's disease Sensory Attention Focused Exercise

Externally Focused PD-SAFEx

EXPERIMENTAL

While performing the exercises from the PD-SAFEx™ program, participants will be instructed to focus their attention externally on the movement of coloured labels attached to their feet, knees, elbows and hands. Participants will be reminded and encouraged by the exercise instructor and volunteers to perform all exercises while focusing attention on the labels.

Behavioral: Parkinson's disease Sensory Attention Focused Exercise

Control Group

NO INTERVENTION

This group will be asked to refrain from changing activities of their daily lives throughout the 20-week duration of the experiment (from pre-assessment to washout).

Interventions

Parkinson's disease Sensory Attention Focused ExerciseBEHAVIORAL

The first half of the exercise class will include walking exercises that include large magnitude and coordinated movements. All walking will be performed slowly. Walking exercises will be followed by balance, stretching, and coordination exercises while sitting in, or standing near, standard office chairs, utilizing latex Thera-bands®. To ensure that balance and coordination are constantly challenged throughout the intervention, the exercise program progresses each week, increasing in difficulty. Depending on the task, the first set of each exercise will be performed with 'eyes-open' to familiarize participants with the task, and subsequent sets will be performed with 'eyes-closed'. If there is only one set for a specific exercise, the first half of the repetitions will be performed with 'eyes-open' and the second half with 'eyes-closed'.

Also known as: PD-SAFEx
Externally Focused PD-SAFExInternally Focused PD-SAFEx

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Either gender, no age or location restriction
  • Diagnosed with idiopathic Parkinson's disease by a Neurologist
  • Able to stand 2 minutes, unassisted
  • Able to walk 10 meters, unassisted
  • Able to understand English instructions

You may not qualify if:

  • A neurological disease other than Parkinson's disease
  • Peripheral neuropathy
  • Clinically diagnosed with dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Wulf G, Landers M, Lewthwaite R, Tollner T. External focus instructions reduce postural instability in individuals with Parkinson disease. Phys Ther. 2009 Feb;89(2):162-8. doi: 10.2522/ptj.20080045. Epub 2008 Dec 12.

    PMID: 19074619BACKGROUND

  • 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.

    PMID: 19373930BACKGROUND

  • 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.

    PMID: 38588457DERIVED

  • 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.

    PMID: 36602886DERIVED

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Study Officials

  • Quincy J Almeida, PhD

    Sun Life Financial Movement Disorders Research and Rehabilitation Centre, Wilfrid Laurier University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

June 16, 2015

First Posted

June 19, 2015

Study Start

August 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

August 31, 2017

Record last verified: 2017-08