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

NCT ID: NCT01955889

Last Updated: 2017-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Mobile Health Technology

Intervention Type BEHAVIORAL

Stretching & Strengthening Exercises

Intervention Type BEHAVIORAL

Walking with Pedometer

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Stretching & Strengthening Exercises

Intervention Type BEHAVIORAL

Walking with Pedometer

Intervention Type BEHAVIORAL

Interventions

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Mobile Health Technology

Intervention Type BEHAVIORAL

Stretching & Strengthening Exercises

Intervention Type BEHAVIORAL

Walking with Pedometer

Intervention Type BEHAVIORAL

Eligibility Criteria

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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))
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston University Charles River Campus

OTHER

Sponsor Role lead

Responsible Party

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Theresa D Ellis

Assistant Professor and Director of Center for Neurorehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Terry Ellis, PhD, PT, NCS

Role: PRINCIPAL_INVESTIGATOR

Boston University

Nancy Latham, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22818941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18361474 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22818934 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21750523 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22208412 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22592060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22895932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22003171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23288910 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23552335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14715035 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15827910 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22281837 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21820940 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18519873 (View on PubMed)

Shulman LM. Understanding disability in Parkinson's disease. Mov Disord. 2010;25 Suppl 1:S131-5. doi: 10.1002/mds.22789.

Reference Type BACKGROUND
PMID: 20187231 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11881269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21937891 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21367643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20077478 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30715489 (View on PubMed)

Related Links

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http://www.bu.edu/neurorehab/research/

Center for Neurorehabilitation at Boston University

Other Identifiers

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BU-SAR-635

Identifier Type: -

Identifier Source: org_study_id

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