NCT02615548

Brief Summary

Physical activity is a key intervention used to reduce the healthcare costs and the negative consequences of Parkinson Disease (PD) by improving walking and balance and reducing the number of falls. However, not all exercise classes provide the same results for people with PD. Specific exercises designed to target the features of PD have shown greater outcomes than generic physical activity. The exercise principles include high-intensity (size and speed) movement, task repetition, rhythmical rocking, mental imagery, cognitive strategies, treadmill walking, and making use of internal and external cues. Collectively these PD-specific exercises can be designed to be run in exercise groups. Structured exercise groups also include social interaction that is known to improve depression and apathy, both of which are features common in people with PD. This study will compare the effect of specific, long-term community-based exercise class on balance, walking, quality of life, and mood compare to self-directed exercise. Investigators anticipate that participants from the community-based, long-term intervention will show better improvements in balance and walking compare to participants that are self-directing their activities.

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
30

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2016

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

First Submitted

Initial submission to the registry

November 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

November 23, 2015

Last Update Submit

November 18, 2016

Conditions

Keywords

exercises

Outcome Measures

Primary Outcomes (1)

  • . Functional Gait Assessment (FGA)

    FGA is a 10-item test, assessing walking and balance.It is well validated as a predictor for falls for people with PD

    Assess the change between baseline and post 9-month intervention.

Secondary Outcomes (2)

  • 6 minute walk test (6MWT)-

    Assess the change between baseline and post 9-month intervention.

  • Semi-structured interview

    Assess the change between baseline and post 9-month intervention.

Study Arms (2)

Community exercise class

EXPERIMENTAL

Regular community exercise class is the intervention. It is an exercise class that incorporate PWR moves( UP,ROCK,STEP,TWIST) and cardiovascular training.

Other: community-based exercise class

self-directed exercise activity

ACTIVE COMPARATOR

Self-directed exercise.

Other: self-directed physical activity

Interventions

This intervention will be held in a community centre, twice per week, for 36 weeks.The participants will have an educational session regarding importance of regular exercise.The class will consist of evidence-based exercises such as: sustained, high effort exercises, resistance exercises, and endurance training.Two trainers with specific for Parkinson Disease training will lead the class.

Community exercise class

Participants from this group will have an educational session regarding importance of regular exercises for Parkinson Disease and will be asked to stay as active as possible.Both groups will be asked to fill out physical activity diary.

self-directed exercise activity

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic PD
  • Hoehn \& Yahr stages 1 to 3 (17).These stages define early to mid-stage of PD.
  • Adult men and/or women, age 45-80
  • Willing and able to participate in 60-minute of physical activity, 3/week for 12-weeks, then 2/week for 36 weeks

You may not qualify if:

  • History of any neurological, cardiovascular, or orthopedic condition that can limit their ability to participate
  • Individuals who self-report engaging in more than 120 minutes of vigorous physical activity per week at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lions Gate Hospital

North Vancouver, British Columbia, V7M 1P4, Canada

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Diana Krasteva, Bachelor's

    Vancouver Coastal Health/ University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

November 23, 2015

First Posted

November 26, 2015

Study Start

March 1, 2016

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

November 22, 2016

Record last verified: 2016-11

Locations