NCT01246700

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

November 23, 2010

Status Verified

September 1, 2010

Enrollment Period

1.5 years

First QC Date

November 22, 2010

Last Update Submit

November 22, 2010

Conditions

Keywords

Parkinson's diseaseRandomized single-blind crossover trialSensory Attention Focused Exercise

Outcome Measures

Primary Outcomes (1)

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

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

    Baseline, 12 weeks and 24 weeks

Secondary Outcomes (7)

  • Timed up and go

    Baseline, 12 weeks and 24 weeks

  • 30 second chair stand

    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).

    Baseline, 12 weeks and 24 weeks

  • Grooved Pegboard

    Baseline, 12 weeks and 24 weeks

  • Step Length

    Baseline, 12 weeks and 24 weeks

  • +2 more secondary outcomes

Study Arms (2)

Group A

EXPERIMENTAL

Participants received 12 weeks of Sensory Attention Focused Exercise, then received 12 weeks of no exercise.

Other: Sensory Attention Focused Exercise (SAFEx)

Group B

EXPERIMENTAL

Participants received no treatment for 12 weeks, then received Sensory Attention Focused Exercise for 12 weeks.

Other: Sensory Attention Focused Exercise (SAFEx)

Interventions

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.

Group A

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Waterloo, Ontario, N2L 3J4, Canada

Location

Related Publications (6)

  • 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
  • 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.

    PMID: 19938164BACKGROUND
  • 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.

    PMID: 17229744BACKGROUND
  • 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.

    PMID: 8145901BACKGROUND
  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Quincy J Almeida, Ph.D

    Sun Life Financial Movement Disorders Research and Rehabilitation Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2010

First Posted

November 23, 2010

Study Start

June 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

November 23, 2010

Record last verified: 2010-09

Locations