Telephone-linked Home-based Exercise Training in PD
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Structural exercise
Health education
Sponsored by
About this trial
This is an interventional other trial for Parkinson's Disease focused on measuring Parkinson's disease, exercise therapy, quality of life
Eligibility Criteria
Inclusion Criteria:
- Physician diagnosis of idiopathic, typical Parkinson's disease (PD)
- At least 2 of 3 cardial signs of PD
- Response to dopaminergic medication
- Depression
Exclusion Criteria:
- Angina pectoris
- History of myocardial infarction within 6 months
- History of ventricular dysrhythmia requiring current therapy
Sites / Locations
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise
Health Education
Arm Description
Structured exercise
Health education
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02898740
First Posted
September 8, 2016
Last Updated
October 30, 2019
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02898740
Brief Title
Telephone-linked Home-based Exercise Training in PD
Official Title
Telephone-linked Home-based Exercise Training in PD
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project is investigating whether a home-based exercise program will reduce depression in patients with Parkinson's disease.
Detailed Description
Background/Rationale:
Nonmotor symptoms in Parkinson's disease (PD) are thought to be present from the early stages of disease and are often more disabling and resistant to treatment than motor symptoms. One of the most important and serious of these symptoms is depression. However, there is no consensus on best pharmacological treatment for depression in PD as efficacy is lacking and there is much concern about polypharmacy and safety of various antidepressant medications. Therefore, it is essential that the investigators characterize the effects of nonpharmacological interventions on depression in PD. A number of studies have shown significant benefits of exercise in reducing depressive symptoms. Emerging studies indicate similar benefits of exercise in the form of resistance training in limiting depression in older adults as well as in those with PD.
Objective:
The investigators hypothesize that a home-based exercise intervention will reduce depression in Veterans with depression in PD.
Methods:
The proposed study is a randomized, controlled trial of a structured exercise intervention, evaluating effects on depression. Community-dwelling Veterans with depression in PD will be randomized to the exercise intervention or a health education control intervention. Participants will be male and female Veterans with a physician diagnosis of idiopathic, typical PD, with at least 2 of 3 cardinal signs of PD, response to dopaminergic medication, and depression. The interventions will last 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, exercise therapy, quality of life
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Structured exercise
Arm Title
Health Education
Arm Type
Active Comparator
Arm Description
Health education
Intervention Type
Behavioral
Intervention Name(s)
Structural exercise
Intervention Description
Exercise instruction and encouragement
Intervention Type
Behavioral
Intervention Name(s)
Health education
Intervention Description
Provision of general information about a variety of health topics
Primary Outcome Measure Information:
Title
Change in Hamilton Rating Scale for Depression (HAM-D) From Baseline to 6 Months
Description
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).
Time Frame
Baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Physician diagnosis of idiopathic, typical Parkinson's disease (PD)
At least 2 of 3 cardial signs of PD
Response to dopaminergic medication
Depression
Exclusion Criteria:
Angina pectoris
History of myocardial infarction within 6 months
History of ventricular dysrhythmia requiring current therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W Sparrow, DSc
Organizational Affiliation
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telephone-linked Home-based Exercise Training in PD
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