Exercise for Adults With Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

Investigating the Effect of Specific, Long- Term, Community-based Exercises on Walking, Balance, and Quality of Life in Adults With Parkinson Disease.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02615548
• Other study ID #: H15-01772
• Status: Active, not recruiting
• Phase: N/A
• First received: November 23, 2015
• Last updated: November 18, 2016
• Start date: March 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Lions Gate Hospital	North Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Vancouver Coastal Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	. 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.	No
Secondary	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.	Assess the change between baseline and post 9-month intervention.	No
Secondary	Semi-structured interview	To assess the attitude of participants toward the intervention	Assess the change between baseline and post 9-month intervention.	No