Exercise for Adults With Parkinson Disease

Sponsor
University of British Columbia (Other)
Overall Status
Unknown status
CT.gov ID
NCT02615548
Collaborator
Vancouver Coastal Health (Other)
30
1
2
21
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: community-based exercise class
  • Other: self-directed physical activity
N/A

Detailed Description

This is a mixed-method, randomized design study. Participants will be assessed using qualitative and quantitative measures before and after a nine-month intervention.Outcome measures for motor function will be described using Paired t-tests for continuous variables and McNemar's Test for categorical variables. Participants will be recruited from the LGH NROP program, North Shore physicians, and the Pacific Parkinson's Research Centre Movement Disorders Clinic, UBC. Potential participants will be approached by their treating physicians during their clinical visits. People who are interested in participating in the study will be invited to contact the NROP Registered Nurse (RN) to discuss study participation and review the inclusion and exclusion criteria. The study will recruit fifteen participants for the intensive community-based exercise group and fifteen for the self-directed exercise group.The sample size calculation was performed using G*power 3.1.9.2.Once participants provide a signed informed consent they will be randomly assigned to one of the groups by picking a number from 00 to 30 out of an envelope.

The class will consist of evidence-based exercises such as: sustained, high effort exercises, resistance exercises, and endurance training. The other participants will continue on their own. All participants will be asked to fill out a physical activity diary regarding the frequency, duration, and intensity of the activities during the nine months trial.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Investigating the Effect of Specific, Long- Term, Community-based Exercises on Walking, Balance, and Quality of Life in Adults With Parkinson Disease.
Study Start Date :
Mar 1, 2016
Anticipated Primary Completion Date :
Jul 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Community exercise class

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
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.

Active Comparator: self-directed exercise activity

Self-directed exercise.

Other: self-directed physical activity
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.

Outcome Measures

Primary Outcome Measures

  1. . Functional Gait Assessment (FGA) [Assess the change between baseline and post 9-month intervention.]

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

Secondary Outcome Measures

  1. 6 minute walk test (6MWT)- [Assess the change between baseline and post 9-month intervention.]

    6 MWT assesses physical endurance. Participants will be asked to walk down a hallway at a comfortable speed for 6 min.

  2. Semi-structured interview [Assess the change between baseline and post 9-month intervention.]

    To assess the attitude of participants toward the intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lions Gate Hospital North Vancouver British Columbia Canada V7M 1P4

Sponsors and Collaborators

  • University of British Columbia
  • Vancouver Coastal Health

Investigators

  • Principal Investigator: Diana Krasteva, Bachelor's, Vancouver Coastal Health/ University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Diana Krasteva, Physiotherapist, University of British Columbia
ClinicalTrials.gov Identifier:
NCT02615548
Other Study ID Numbers:
  • H15-01772
First Posted:
Nov 26, 2015
Last Update Posted:
Nov 22, 2016
Last Verified:
Nov 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Diana Krasteva, Physiotherapist, University of British Columbia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2016