search
Back to results

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
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

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

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 8, 2016
Last Updated
October 30, 2019
Sponsor
VA Office of Research and Development
search

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

We'll reach out to this number within 24 hrs