Parkinson DiseaseNCT01955889

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

A study testing Mobile Health Technology, Stretching & Strengthening Exercises and Walking with Pedometer in people with Parkinson Disease, run by Boston University Charles River Campus at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Parkinson Disease
What is being tested?: Mobile Health Technology, Stretching & Strengthening Exercises and Walking with Pedometer
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Oct 2013to Jul 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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))

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

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.

Conditions: Parkinson Disease
Being tested: Mobile Health Technology, Stretching & Strengthening Exercises, Walking with Pedometer
Keywords: Exercise, Rehabilitation, Telemedicine
Medical subject headings: Parkinson Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mobile Health TechnologyBehavioural
Stretching & Strengthening ExercisesBehavioural
Walking with PedometerBehavioural

Study groups in NCT01955889
Study group	Role	What they receive
Mobile Health Technology	Experimental	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 Receives: Behavioral: Mobile Health Technology; Behavioral: Stretching & Strengthening Exercises; Behavioral: Walking with Pedometer
Control	Active comparator	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 Receives: Behavioral: Stretching & Strengthening Exercises; Behavioral: Walking with Pedometer

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 52-54 weeks

Secondary outcomes (11)

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
Measured: 52-54 weeks
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
Measured: 52-54 weeks
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
Measured: 52-54 weeks
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.
Measured: 52-54 weeks
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
Measured: 52-54 weeks
Change from Baseline in Self-Efficacy Exercise Scale
Self-Efficacy Exercise Scale is a self-administered questionnaire to assess confidence in ability to exercise
Measured: 52-54 weeks
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
Measured: 52-54 weeks
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
Measured: 52-54 weeks
Change from Baseline in Geriatric Depression Scale
Geriatric Depression Scale is a self-administered questionnaire to assess depression in individuals
Measured: 52-54 weeks
Change from Baseline Apathy Scale
Apathy Scale is a self-administered questionnaire to assess apathy
Measured: 52-54 weeks
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
Measured: 52-54 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Jul 2015

First posted8 Oct 2013 (estimated)
Study startOct 2013
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01955889
Sponsor's protocol ID: BU-SAR-635
Status last verified: Jul 2017
First submitted: 24 Sep 2013
Last updated: 19 Jul 2017
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 22818941
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.
PubMed 18361474
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.
PubMed 22818934
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.
PubMed 21750523
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.
PubMed 22208412
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.
PubMed 22592060
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.
PubMed 22895932
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.
PubMed 22003171
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.
PubMed 23288910
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.
PubMed 23552335
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.
PubMed 14715035
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.
PubMed 15827910
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.
PubMed 22281837
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.
PubMed 21820940
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.
PubMed 18519873

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mobile Health Technology to Promote Physical Activity in Persons With Parkinson Disease
ClinicalTrials.gov ID: NCT01955889
Acronym / sponsor ID: BU-SAR-635
Conditions: Parkinson Disease
Keywords: Exercise, Rehabilitation, Telemedicine
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Boston University Charles River CampusUniversity, hospital or other
Study start: Oct 2013
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 8 Oct 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Mobile Health Technology	Experimental	Behavioral: Mobile Health Technology, Behavioral: Stretching & Strengthening Exercises, Behavioral: Walking with PedometerStretching 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
Control	Active comparator	Behavioral: Stretching & Strengthening Exercises, Behavioral: Walking with PedometerStretching 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

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (4 listed)

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))

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mobile Health Technology	Behavioural	Mobile Health Technology
Stretching & Strengthening Exercises	Behavioural	Control, Mobile Health Technology
Walking with Pedometer	Behavioural	Control, Mobile Health Technology

Primary outcome

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

11 secondary outcomes

Change from Baseline in BriefBEST Balance Test
Time frame: 52-54 weeks
Change from Baseline in Six Minute Walk Test
Time frame: 52-54 weeks
Change from Baseline in Falls Self-Efficacy Scale International
Time frame: 52-54 weeks
Change from Baseline in Unified Parkinson's Disease Rating Scale
Time frame: 52-54 weeks
Change from Baseline in Parkinson's Disease Questionnaire-39
Time frame: 52-54 weeks
Change from Baseline in Self-Efficacy Exercise Scale
Time frame: 52-54 weeks
Change from Baseline in Functional Gait Assessment
Time frame: 52-54 weeks
Change from Baseline in Fatigue Severity Scale
Time frame: 52-54 weeks
Change from Baseline in Geriatric Depression Scale
Time frame: 52-54 weeks
Change from Baseline Apathy Scale
Time frame: 52-54 weeks
Change from Baseline in Godin Leisure-Time Exercise Questionnaire
Time frame: 52-54 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
Background: PubMed 22818941Kohl 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.
Background: PubMed 18361474Shulman 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.
Background: PubMed 22818934Rimmer 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.
Background: PubMed 21750523Speelman 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.
Background: PubMed 22208412Sisson 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.
Background: PubMed 22592060Cavanaugh 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.
Background: PubMed 22895932Tomlinson 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.
Background: PubMed 22003171Ellis 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.
Background: PubMed 23288910Ellis 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.
Background: PubMed 23552335Ellis 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.
Background: PubMed 14715035Tudor-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.
Background: PubMed 15827910Ellis 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.
Center for Neurorehabilitation at Boston UniversityLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Terry Ellis, PhD, PT, NCS principal investigator

Boston University

Nancy Latham, PhD, PT principal investigator

Boston University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Physical Activity Level (time frame: 52-54 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01955889, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.