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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Health Technology
Stretching & Strengthening Exercises
Walking with Pedometer
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Exercise, Rehabilitation, Telemedicine

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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))

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile Health Technology

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from Baseline in Physical Activity Level
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 Outcome Measures

Change from Baseline in BriefBEST Balance Test
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
Change from Baseline in Six Minute Walk Test
Six Minute Walk Test is measure of the distance a participant is able to walk in a 6 minute time period
Change from Baseline in Falls Self-Efficacy Scale International
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
Change from Baseline in Unified Parkinson's Disease Rating Scale
Unified Parkinson's Disease Rating Scale assesses disability level related to the non-motor and motor signs in people with Parkinson's disease.
Change from Baseline in Parkinson's Disease Questionnaire-39
Parkinson's Disease Questionnaire-39 is a self-administered questionnaire to assess the quality of life in people with Parkinson's disease
Change from Baseline in Self-Efficacy Exercise Scale
Self-Efficacy Exercise Scale is a self-administered questionnaire to assess confidence in ability to exercise
Change from Baseline in Functional Gait Assessment
Functional Gait Assessment assesses balance using a series of walking tasks, including walking in different directions, speeds, and around obstacles, including navigating stairs
Change from Baseline in Fatigue Severity Scale
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
Change from Baseline in Geriatric Depression Scale
Geriatric Depression Scale is a self-administered questionnaire to assess depression in individuals
Change from Baseline Apathy Scale
Apathy Scale is a self-administered questionnaire to assess apathy
Change from Baseline in Godin Leisure-Time Exercise Questionnaire
Godin Leisure-Time Exercise Questionnaire a self-administered questionnaire about the subjects leisure-time exercise habits over a typical seven day period

Full Information

First Posted
September 24, 2013
Last Updated
July 18, 2017
Sponsor
Boston University Charles River Campus
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1. Study Identification

Unique Protocol Identification Number
NCT01955889
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University Charles River Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Exercise, Rehabilitation, Telemedicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile Health Technology
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Mobile Health Technology
Intervention Type
Behavioral
Intervention Name(s)
Stretching & Strengthening Exercises
Intervention Type
Behavioral
Intervention Name(s)
Walking with Pedometer
Primary Outcome Measure Information:
Title
Change from Baseline in Physical Activity Level
Description
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
Time Frame
52-54 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in BriefBEST Balance Test
Description
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
Time Frame
52-54 weeks
Title
Change from Baseline in Six Minute Walk Test
Description
Six Minute Walk Test is measure of the distance a participant is able to walk in a 6 minute time period
Time Frame
52-54 weeks
Title
Change from Baseline in Falls Self-Efficacy Scale International
Description
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
Time Frame
52-54 weeks
Title
Change from Baseline in Unified Parkinson's Disease Rating Scale
Description
Unified Parkinson's Disease Rating Scale assesses disability level related to the non-motor and motor signs in people with Parkinson's disease.
Time Frame
52-54 weeks
Title
Change from Baseline in Parkinson's Disease Questionnaire-39
Description
Parkinson's Disease Questionnaire-39 is a self-administered questionnaire to assess the quality of life in people with Parkinson's disease
Time Frame
52-54 weeks
Title
Change from Baseline in Self-Efficacy Exercise Scale
Description
Self-Efficacy Exercise Scale is a self-administered questionnaire to assess confidence in ability to exercise
Time Frame
52-54 weeks
Title
Change from Baseline in Functional Gait Assessment
Description
Functional Gait Assessment assesses balance using a series of walking tasks, including walking in different directions, speeds, and around obstacles, including navigating stairs
Time Frame
52-54 weeks
Title
Change from Baseline in Fatigue Severity Scale
Description
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
Time Frame
52-54 weeks
Title
Change from Baseline in Geriatric Depression Scale
Description
Geriatric Depression Scale is a self-administered questionnaire to assess depression in individuals
Time Frame
52-54 weeks
Title
Change from Baseline Apathy Scale
Description
Apathy Scale is a self-administered questionnaire to assess apathy
Time Frame
52-54 weeks
Title
Change from Baseline in Godin Leisure-Time Exercise Questionnaire
Description
Godin Leisure-Time Exercise Questionnaire a self-administered questionnaire about the subjects leisure-time exercise habits over a typical seven day period
Time Frame
52-54 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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))
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Ellis, PhD, PT, NCS
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nancy Latham, PhD, PT
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22818941
Citation
Kohl HW 3rd, Craig CL, Lambert EV, Inoue S, Alkandari JR, Leetongin G, Kahlmeier S; Lancet Physical Activity Series Working Group. The pandemic of physical inactivity: global action for public health. Lancet. 2012 Jul 21;380(9838):294-305. doi: 10.1016/S0140-6736(12)60898-8.
Results Reference
background
PubMed Identifier
18361474
Citation
Shulman LM, Gruber-Baldini AL, Anderson KE, Vaughan CG, Reich SG, Fishman PS, Weiner WJ. The evolution of disability in Parkinson disease. Mov Disord. 2008 Apr 30;23(6):790-6. doi: 10.1002/mds.21879.
Results Reference
background
PubMed Identifier
22818934
Citation
Rimmer JH, Marques AC. Physical activity for people with disabilities. Lancet. 2012 Jul 21;380(9838):193-5. doi: 10.1016/S0140-6736(12)61028-9. No abstract available.
Results Reference
background
PubMed Identifier
21750523
Citation
Speelman AD, van de Warrenburg BP, van Nimwegen M, Petzinger GM, Munneke M, Bloem BR. How might physical activity benefit patients with Parkinson disease? Nat Rev Neurol. 2011 Jul 12;7(9):528-34. doi: 10.1038/nrneurol.2011.107.
Results Reference
background
PubMed Identifier
22208412
Citation
Sisson SB, Camhi SM, Tudor-Locke C, Johnson WD, Katzmarzyk PT. Characteristics of step-defined physical activity categories in U.S. adults. Am J Health Promot. 2012 Jan-Feb;26(3):152-9. doi: 10.4278/ajhp.100326-QUAN-95.
Results Reference
background
PubMed Identifier
22592060
Citation
Cavanaugh JT, Ellis TD, Earhart GM, Ford MP, Foreman KB, Dibble LE. Capturing ambulatory activity decline in Parkinson's disease. J Neurol Phys Ther. 2012 Jun;36(2):51-7. doi: 10.1097/NPT.0b013e318254ba7a.
Results Reference
background
PubMed Identifier
22895932
Citation
Tomlinson CL, Patel S, Meek C, Clarke CE, Stowe R, Shah L, Sackley CM, Deane KH, Herd CP, Wheatley K, Ives N. Physiotherapy versus placebo or no intervention in Parkinson's disease. Cochrane Database Syst Rev. 2012 Aug 15;(8):CD002817. doi: 10.1002/14651858.CD002817.pub3.
Results Reference
background
PubMed Identifier
22003171
Citation
Ellis T, Cavanaugh JT, Earhart GM, Ford MP, Foreman KB, Fredman L, Boudreau JK, Dibble LE. Factors associated with exercise behavior in people with Parkinson disease. Phys Ther. 2011 Dec;91(12):1838-48. doi: 10.2522/ptj.20100390. Epub 2011 Oct 14.
Results Reference
background
PubMed Identifier
23288910
Citation
Ellis T, Boudreau JK, DeAngelis TR, Brown LE, Cavanaugh JT, Earhart GM, Ford MP, Foreman KB, Dibble LE. Barriers to exercise in people with Parkinson disease. Phys Ther. 2013 May;93(5):628-36. doi: 10.2522/ptj.20120279. Epub 2013 Jan 3.
Results Reference
background
PubMed Identifier
23552335
Citation
Ellis T, Latham NK, DeAngelis TR, Thomas CA, Saint-Hilaire M, Bickmore TW. Feasibility of a virtual exercise coach to promote walking in community-dwelling persons with Parkinson disease. Am J Phys Med Rehabil. 2013 Jun;92(6):472-81; quiz 482-5. doi: 10.1097/PHM.0b013e31828cd466.
Results Reference
background
PubMed Identifier
14715035
Citation
Tudor-Locke C, Bassett DR Jr. How many steps/day are enough? Preliminary pedometer indices for public health. Sports Med. 2004;34(1):1-8. doi: 10.2165/00007256-200434010-00001.
Results Reference
background
PubMed Identifier
15827910
Citation
Ellis T, de Goede CJ, Feldman RG, Wolters EC, Kwakkel G, Wagenaar RC. Efficacy of a physical therapy program in patients with Parkinson's disease: a randomized controlled trial. Arch Phys Med Rehabil. 2005 Apr;86(4):626-32. doi: 10.1016/j.apmr.2004.08.008.
Results Reference
background
PubMed Identifier
22281837
Citation
Watson A, Bickmore T, Cange A, Kulshreshtha A, Kvedar J. An internet-based virtual coach to promote physical activity adherence in overweight adults: randomized controlled trial. J Med Internet Res. 2012 Jan 26;14(1):e1. doi: 10.2196/jmir.1629.
Results Reference
background
PubMed Identifier
21820940
Citation
Ellis T, Cavanaugh JT, Earhart GM, Ford MP, Foreman KB, Dibble LE. Which measures of physical function and motor impairment best predict quality of life in Parkinson's disease? Parkinsonism Relat Disord. 2011 Nov;17(9):693-7. doi: 10.1016/j.parkreldis.2011.07.004. Epub 2011 Aug 5.
Results Reference
background
PubMed Identifier
18519873
Citation
Muslimovic D, Post B, Speelman JD, Schmand B, de Haan RJ; CARPA Study Group. Determinants of disability and quality of life in mild to moderate Parkinson disease. Neurology. 2008 Jun 3;70(23):2241-7. doi: 10.1212/01.wnl.0000313835.33830.80.
Results Reference
background
PubMed Identifier
20187231
Citation
Shulman LM. Understanding disability in Parkinson's disease. Mov Disord. 2010;25 Suppl 1:S131-5. doi: 10.1002/mds.22789.
Results Reference
background
PubMed Identifier
11881269
Citation
Resnick B, Nahm ES, Orwig D, Zimmerman SS, Magaziner J. Measurement of activity in older adults: reliability and validity of the Step Activity Monitor. J Nurs Meas. 2001 Winter;9(3):275-90.
Results Reference
background
PubMed Identifier
21937891
Citation
Schmidt AL, Pennypacker ML, Thrush AH, Leiper CI, Craik RL. Validity of the StepWatch Step Activity Monitor: preliminary findings for use in persons with Parkinson disease and multiple sclerosis. J Geriatr Phys Ther. 2011 Jan-Mar;34(1):41-5. doi: 10.1519/JPT.0b013e31820aa921.
Results Reference
background
PubMed Identifier
21367643
Citation
Speelman AD, van Nimwegen M, Borm GF, Bloem BR, Munneke M. Monitoring of walking in Parkinson's disease: validation of an ambulatory activity monitor. Parkinsonism Relat Disord. 2011 Jun;17(5):402-4. doi: 10.1016/j.parkreldis.2011.02.006. Epub 2011 Mar 1. No abstract available.
Results Reference
background
PubMed Identifier
20077478
Citation
Tickle-Degnen L, Ellis T, Saint-Hilaire MH, Thomas CA, Wagenaar RC. Self-management rehabilitation and health-related quality of life in Parkinson's disease: a randomized controlled trial. Mov Disord. 2010 Jan 30;25(2):194-204. doi: 10.1002/mds.22940.
Results Reference
background
PubMed Identifier
30715489
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.
Results Reference
derived
Links:
URL
http://www.bu.edu/neurorehab/research/
Description
Center for Neurorehabilitation at Boston University

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

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