Clinical trial NCT01955889: Mobile Health Technology to Promote Physical Activity in Persons With Parkinson Disease
Official title: Mobile Health Technology to Promote Physical Activity in Persons With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Exercise
Rehabilitation
Telemedicine
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Persons with Parkinson Disease (PD) face significant declines in function resulting in greater disability. Function can improve through participation in exercise, yet many people with PD are physically inactive. Given that people with PD live long lifespans following diagnosis; it is essential to include routine exercise into their lives over the long-term. Physical therapy is effective in improving function in persons with PD. However, participation in on-going physical therapy indefinitely is not a realistic option due to limited healthcare resources. Interventions using mobile health technologies allow physical therapists to stay connected to patients over time potentially improving their ability to meet the changing needs of patients with PD. Innovative approaches using mobile health technology may improve outcome; however, the effectiveness of different approaches to improve function and reduce disability in PD is unknown.

The purpose of this study is to compare the effectiveness of two interventions to improve function and health-related quality of life in 65 people with PD. In one study group, participants receive a home exercise program, in written format, to continue on an independent basis. In the other study group, participants are instructed to continue with an exercise program, in their home, delivered using videos of the exercises on a computer tablet device. This use of mobile-Health technology allows the physical therapist to remotely monitor participants' progress and modify the exercise program to meet the changing needs of each patient. The long-term objective of this research is to determine the most efficient and effective way to improve function that can be widely disseminated to persons with PD.


Eligibility criteria: Inclusion Criteria:

* Inactive over the last 3 months
* Clinical diagnosis of idiopathic Parkinson's disease
* Mild to moderate disease severity
* Sufficient cognitive ability to follow study instructions
* Stable dose of Parkinson's medications for at least 2 weeks prior to study onset and during the 12 month study period unless medically necessary
* Able to walk without physical assistance or an assistive device for at least 6 continuous minutes
* Be interested in participating and provide informed consent

Exclusion Criteria:

* A diagnosis of atypical Parkinsonism
* Balance impairment (More than 2 falls in the previous month)
* Significant freezing
* Serious co-morbidities or medical conditions that may interfere with ability to participate in an exercise program (i.e., musculoskeletal, cardiovascular, and neurological (other than Parkinson's))

Primary outcomes:
measure: Change from Baseline in Physical Activity Level
timeFrame: 52-54 weeks
Secondary outcomes:
measure: Change from Baseline in BriefBEST Balance Test
timeFrame: 52-54 weeks
measure: Change from Baseline in Six Minute Walk Test
timeFrame: 52-54 weeks
measure: Change from Baseline in Falls Self-Efficacy Scale International
timeFrame: 52-54 weeks
measure: Change from Baseline in Unified Parkinson's Disease Rating Scale
timeFrame: 52-54 weeks
measure: Change from Baseline in Parkinson's Disease Questionnaire-39
timeFrame: 52-54 weeks
measure: Change from Baseline in Self-Efficacy Exercise Scale
timeFrame: 52-54 weeks
measure: Change from Baseline in Functional Gait Assessment
timeFrame: 52-54 weeks
measure: Change from Baseline in Fatigue Severity Scale
timeFrame: 52-54 weeks
measure: Change from Baseline in Geriatric Depression Scale
timeFrame: 52-54 weeks
measure: Change from Baseline Apathy Scale
timeFrame: 52-54 weeks
measure: Change from Baseline in Godin Leisure-Time Exercise Questionnaire
timeFrame: 52-54 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Terry Ellis, PhD, PT, NCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Nancy Latham, PhD, PT
role: PRINCIPAL_INVESTIGATOR
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citation: Ellis TD, Cavanaugh JT, DeAngelis T, Hendron K, Thomas CA, Saint-Hilaire M, Pencina K, Latham NK. Comparative Effectiveness of mHealth-Supported Exercise Compared With Exercise Alone for People With Parkinson Disease: Randomized Controlled Pilot Study. Phys Ther. 2019 Feb 1;99(2):203-216. doi: 10.1093/ptj/pzy131.