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Completed

NCT Number: NCT01955889

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Motor Activity Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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))

Treatment and study plan

Mobile Health Technology

Behavioral

Stretching & Strengthening Exercises

Behavioral

Walking with Pedometer

Behavioral

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Change from Baseline Apathy Scale

    Time frame: 52-54 weeks

    Apathy Scale is a self-administered questionnaire to assess apathy

  11. 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

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 8, 2013
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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