Telephone-linked Home-based Exercise Training in PD
1 other identifier
interventional
40
1 country
1
Brief Summary
This project is investigating whether a home-based exercise program will reduce depression in patients with Parkinson's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2016
CompletedFirst Posted
Study publicly available on registry
September 13, 2016
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedResults Posted
Study results publicly available
November 21, 2019
CompletedNovember 21, 2019
October 1, 2019
1.7 years
September 8, 2016
October 30, 2019
October 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Hamilton Rating Scale for Depression (HAM-D) From Baseline to 6 Months
The HAM-D is the most widely used and accepted measure for evaluating depression severity. The HAM-D scores range from a minimum of 0 to a maximum of 50. Higher scores indicate more severe depression. Change = (6 month score) - (baseline score).
Baseline and 6 months
Study Arms (2)
Exercise
EXPERIMENTALStructured exercise
Health Education
ACTIVE COMPARATORHealth education
Interventions
Provision of general information about a variety of health topics
Eligibility Criteria
You may qualify if:
- Physician diagnosis of idiopathic, typical Parkinson's disease (PD)
- At least 2 of 3 cardial signs of PD
- Response to dopaminergic medication
- Depression
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. David Sparrow
- Organization
- VA Boston Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
David W Sparrow, DSc
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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
September 8, 2016
First Posted
September 13, 2016
Study Start
February 1, 2017
Primary Completion
October 31, 2018
Study Completion
December 31, 2018
Last Updated
November 21, 2019
Results First Posted
November 21, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share