Exercise for Adults With Parkinson Disease
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
community-based exercise class
self-directed physical activity
Sponsored by
About this trial
This is an interventional supportive care trial for Parkinson Disease focused on measuring exercises
Eligibility Criteria
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
Sites / Locations
- Lions Gate Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Community exercise class
self-directed exercise activity
Arm Description
Regular community exercise class is the intervention. It is an exercise class that incorporate PWR moves( UP,ROCK,STEP,TWIST) and cardiovascular training.
Self-directed exercise.
Outcomes
Primary Outcome Measures
. 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
Secondary Outcome Measures
6 minute walk test (6MWT)-
6 MWT assesses physical endurance. Participants will be asked to walk down a hallway at a comfortable speed for 6 min.
Semi-structured interview
To assess the attitude of participants toward the intervention
Full Information
NCT ID
NCT02615548
First Posted
November 23, 2015
Last Updated
November 18, 2016
Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health
1. Study Identification
Unique Protocol Identification Number
NCT02615548
Brief Title
Exercise for Adults With Parkinson Disease
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
exercises
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Community exercise class
Arm Type
Experimental
Arm Description
Regular community exercise class is the intervention. It is an exercise class that incorporate PWR moves( UP,ROCK,STEP,TWIST) and cardiovascular training.
Arm Title
self-directed exercise activity
Arm Type
Active Comparator
Arm Description
Self-directed exercise.
Intervention Type
Other
Intervention Name(s)
community-based exercise class
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
self-directed physical activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
. Functional Gait Assessment (FGA)
Description
FGA is a 10-item test, assessing walking and balance.It is well validated as a predictor for falls for people with PD
Time Frame
Assess the change between baseline and post 9-month intervention.
Secondary Outcome Measure Information:
Title
6 minute walk test (6MWT)-
Description
6 MWT assesses physical endurance. Participants will be asked to walk down a hallway at a comfortable speed for 6 min.
Time Frame
Assess the change between baseline and post 9-month intervention.
Title
Semi-structured interview
Description
To assess the attitude of participants toward the intervention
Time Frame
Assess the change between baseline and post 9-month intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Krasteva, Bachelor's
Organizational Affiliation
Vancouver Coastal Health/ University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lions Gate Hospital
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7M 1P4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Exercise for Adults With Parkinson Disease
We'll reach out to this number within 24 hrs