Telephone-linked Home-based Exercise Training in PD

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02898740
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

This project is investigating whether a home-based exercise program will reduce depression in patients with Parkinson's disease.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Behavioral: Structural exercise; Behavioral: Health education	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Telephone-linked Home-based Exercise Training in PD
• Actual Study Start Date: Feb 1, 2017
• Actual Primary Completion Date: Oct 31, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise Structured exercise	Behavioral: Structural exercise; Exercise instruction and encouragement
Active Comparator: Health Education Health education	Behavioral: Health education; Provision of general information about a variety of health topics

Outcome Measures

Primary Outcome Measures

1. Change in Hamilton Rating Scale for Depression (HAM-D) From Baseline to 6 Months [Baseline and 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts	United States	02130

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: David W Sparrow, DSc, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 6, 2018

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02898740
• Other Study ID Numbers: E2362-P
• First Posted: Sep 13, 2016
• Last Update Posted: Nov 21, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by VA Office of Research and Development: Parkinson's disease; exercise therapy; quality of life
• Additional relevant MeSH terms: Parkinson Disease

Study Results

Participant Flow

Arm/Group Title	Exercise	Health Education
Arm/Group Description	Structural exercise: Exercise instruction and encouragement	Health education: Provision of general information about a variety of health topics
Period Title: Overall Study
STARTED	21	19
COMPLETED	21	19
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Exercise	Health Education	Total
Arm/Group Description	Structural exercise: Exercise instruction and encouragement	Health education: Provision of general information about a variety of health topics	Total of all reporting groups
Overall Participants	21	19	40
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	70.7	69.3	70.0
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	21 100%	19 100%	40 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Baseline HAM-D score (years) [Mean (Full Range) ]
Mean (Full Range) [years]	10.7	9.8	10.3

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise	Health Education
Arm/Group Description	Structural exercise: Exercise instruction and encouragement	Health education: Provision of general information about a variety of health topics
Measure Participants	21	19
Mean (Full Range) [units on a scale]	-1.4	2.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise, Health Education
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Mixed Models Analysis
	Comments	models were adjusted for age
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.4
	Confidence Interval	(2-Sided) 95%; -6.8 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.7
	Estimation Comments	treatment difference = Exercise - Health Education

Adverse Events

Time Frame	Baseline to 6 months.
Arm/Group Title	Exercise		Health Education
Arm/Group Description	Structural exercise: Exercise instruction and encouragement		Health education: Provision of general information about a variety of health topics
All Cause Mortality
	Exercise		Health Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/19 (0%)
Serious Adverse Events
	Exercise		Health Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Exercise		Health Education
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.