NCT01639469

Brief Summary

This project is investigating whether a one-year in-home exercise program will reduce the rate of falls and improve strength and quality of life in patients with Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 23, 2017

Completed
Last Updated

June 23, 2017

Status Verified

June 1, 2017

Enrollment Period

3.2 years

First QC Date

July 10, 2012

Results QC Date

April 4, 2017

Last Update Submit

June 22, 2017

Conditions

Keywords

Parkinson DiseaseQuality of LifeExercise Therapy

Outcome Measures

Primary Outcomes (1)

  • Total Falls During the 1-year Follow-up

    Total number of falls over the 1-year follow-up; self-reported falls collected on a weekly basis and totaled over the follow-up period.

    up to 1 year

Study Arms (2)

Structured exercise

EXPERIMENTAL

Structured exercise instruction by smartphone

Behavioral: Structured exercise

lifestyle exercise

ACTIVE COMPARATOR

Lifestyle exercise program taught via smartphone

Behavioral: Lifestyle exercise

Interventions

Structured exercise includes stretching, strengthening, and balance exercises.

Structured exercise

Subjects will be taught lifestyle exercises and advised about mobility strategies

lifestyle exercise

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physician diagnosis of idiopathic, typical Parkinson's disease (PD)
  • At least 2 of 3 cardinal signs of PD
  • Response to dopaminergic medication

You may not qualify if:

  • Angina pectoris
  • History of myocardial infarction within 6 months
  • History of ventricular dysrhythmia requiring current therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Dr. David Sparrow
Organization
VA Boston Healthcare System

Study Officials

  • David W Sparrow, DSc

    VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2012

First Posted

July 12, 2012

Study Start

January 1, 2013

Primary Completion

March 1, 2016

Study Completion

June 1, 2016

Last Updated

June 23, 2017

Results First Posted

June 23, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations