Clinical trial NCT02615548: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: exercises
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Vancouver Coastal Health
First posted: 2015-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: . Functional Gait Assessment (FGA)
timeFrame: Assess the change between baseline and post 9-month intervention.
Secondary outcomes:
measure: 6 minute walk test (6MWT)-
timeFrame: Assess the change between baseline and post 9-month intervention.
measure: Semi-structured interview
timeFrame: Assess the change between baseline and post 9-month intervention.
Other outcomes:
Locations:
city: North Vancouver
country: Canada
facility: Lions Gate Hospital
state: British Columbia
Study officials:
affiliation: Vancouver Coastal Health/ University of British Columbia
name: Diana Krasteva, Bachelor's
role: PRINCIPAL_INVESTIGATOR
References: