Mobile Health Technology to Promote Physical Activity in Persons With Parkinson Disease

July 18, 2017 updated by: Theresa D Ellis, Boston University Charles River Campus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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))

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile Health Technology
Stretching and strengthening exercises provided via video using mobile health technology; walk daily using a pedometer; interact with a physical therapist remotely through an exercise application on a tablet device over 12 month period
Behavioral: Mobile Health Technology
Behavioral: Stretching & Strengthening Exercises
Behavioral: Walking with Pedometer
Active Comparator: Control
Stretching and strengthening exercises provided using printed photographs; walk daily using a pedometer; interact with a physical therapist at the beginning of the 12 month study; no use of mobile technology
Behavioral: Stretching & Strengthening Exercises
Behavioral: Walking with Pedometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Physical Activity Level
Time Frame: 52-54 weeks
Physical activity level will be assessed using an activity monitor worn around the ankle over a 7-day period at the beginning and the end of the study
52-54 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in BriefBEST Balance Test
Time Frame: 52-54 weeks
The BriefBEST balance test assesses balance using a series of tasks such as sitting and leaning, standing on compliant and non-compliant surfaces, stepping to the side, and walking on level surfaces
52-54 weeks
Change from Baseline in Six Minute Walk Test
Time Frame: 52-54 weeks
Six Minute Walk Test is measure of the distance a participant is able to walk in a 6 minute time period
52-54 weeks
Change from Baseline in Falls Self-Efficacy Scale International
Time Frame: 52-54 weeks
Falls Self-Efficacy Scale International is a self-administered questionnaire to assess the level of confidence in performing a series of 16 daily activities without falling
52-54 weeks
Change from Baseline in Unified Parkinson's Disease Rating Scale
Time Frame: 52-54 weeks
Unified Parkinson's Disease Rating Scale assesses disability level related to the non-motor and motor signs in people with Parkinson's disease.
52-54 weeks
Change from Baseline in Parkinson's Disease Questionnaire-39
Time Frame: 52-54 weeks
Parkinson's Disease Questionnaire-39 is a self-administered questionnaire to assess the quality of life in people with Parkinson's disease
52-54 weeks
Change from Baseline in Self-Efficacy Exercise Scale
Time Frame: 52-54 weeks
Self-Efficacy Exercise Scale is a self-administered questionnaire to assess confidence in ability to exercise
52-54 weeks
Change from Baseline in Functional Gait Assessment
Time Frame: 52-54 weeks
Functional Gait Assessment assesses balance using a series of walking tasks, including walking in different directions, speeds, and around obstacles, including navigating stairs
52-54 weeks
Change from Baseline in Fatigue Severity Scale
Time Frame: 52-54 weeks
Fatigue Severity Scale is a self-administered questionnaire where subjects are instructed to rate the impact of fatigue in their daily life over the prior week
52-54 weeks
Change from Baseline in Geriatric Depression Scale
Time Frame: 52-54 weeks
Geriatric Depression Scale is a self-administered questionnaire to assess depression in individuals
52-54 weeks
Change from Baseline Apathy Scale
Time Frame: 52-54 weeks
Apathy Scale is a self-administered questionnaire to assess apathy
52-54 weeks
Change from Baseline in Godin Leisure-Time Exercise Questionnaire
Time Frame: 52-54 weeks
Godin Leisure-Time Exercise Questionnaire a self-administered questionnaire about the subjects leisure-time exercise habits over a typical seven day period
52-54 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University Charles River Campus

Investigators

  • Principal Investigator: Terry Ellis, PhD, PT, NCS, Boston University
  • Principal Investigator: Nancy Latham, PhD, PT, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

September 24, 2013

First Submitted That Met QC Criteria

September 30, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BU-SAR-635

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on Mobile Health Technology

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe