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The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease (PD&Exercise)

Primary Purpose

Parkinson's Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinning Class
Yoga Class
Dance Class
No Exercise Class
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, fatigue, anxiety, depression, exercise

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects diagnosed with Idiopathic Parkinson's Disease
  2. Age between 18 - 75 years
  3. Hoehn and Yahr stage less than or equal to 3
  4. Mini-Mental State Exam (MMSE) score of over 23 at screening
  5. If subjects are taking any medications for depression, fatigue, or anxiety, regimen must be stable for 8 weeks prior to baseline visit
  6. Subjects willing and able to give informed consent

Exclusion Criteria:

  1. Subjects with a diagnosis of an atypical Parkinsonism
  2. Subjects unwilling or unable to obtain Health Waiver from Primary Care Provider
  3. Score of 60 or more on UPDRS III at screening
  4. Scores in the 'normal' range on all three study assessments: Beck Depression Index II, Fatigue Severity Scale, and Zung self-rating Anxiety Scale
  5. Participation in any of the 3 physical activities more than 3 times in the past for 8 weeks prior to baseline
  6. Any other reason that, in the investigator's opinion, would exclude the subject from participation in the study

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Spinning Class

Yoga Class

Dance Class

No Exercise Class

Arm Description

Subjects randomly selected for the spinning group will participate in spinning classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up.

Subjects randomly selected for the yoga group will participate in yoga classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up.

Subjects randomly selected for the dance group will participate in dance classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up.

Subjects randomly selected for the no class group will not participate in the study exercise classes. Subjects will still complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up.

Outcomes

Primary Outcome Measures

Change from baseline, if any, in subjects' Fatigue Severity Scale
Subjects will complete the Fatigue Severity Scale at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end.
Change from baseline, if any, in subjects' Zung self-report Anxiety Scale
Subjects will complete the Zung self-report Anxiety Scale at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end.
Change from baseline, if any, in subjects' Beck Depression Inventory II scale
Subjects will complete the Beck Depression Inventory II at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end.

Secondary Outcome Measures

Full Information

First Posted
August 24, 2016
Last Updated
July 25, 2017
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Parkinson's Disease Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02885285
Brief Title
The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease
Acronym
PD&Exercise
Official Title
The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Recruitment goal not met
Study Start Date
August 2016 (undefined)
Primary Completion Date
February 24, 2017 (Actual)
Study Completion Date
February 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Parkinson's Disease Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to learn about the impact of exercise on fatigue, anxiety, and depression in Parkinson's disease. It is well established that exercise improves the motor symptoms of Parkinson's disease. However, it is not clear which types of exercise are most beneficial for specific non-motor symptoms.
Detailed Description
The investigators are recruiting 32 patients who will be randomized into either a spinning class, yoga class, dance class, or no exercise intervention. Classes will be conducted twice a week for 6 weeks total at times convenient for the patients. Patients will also be asked to complete questionnaires after exercise classes to see if the exercise intervention improves measures of fatigue, anxiety, and depression - and what exercise intervention may be superior.

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, fatigue, anxiety, depression, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinning Class
Arm Type
Experimental
Arm Description
Subjects randomly selected for the spinning group will participate in spinning classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up.
Arm Title
Yoga Class
Arm Type
Experimental
Arm Description
Subjects randomly selected for the yoga group will participate in yoga classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up.
Arm Title
Dance Class
Arm Type
Experimental
Arm Description
Subjects randomly selected for the dance group will participate in dance classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up.
Arm Title
No Exercise Class
Arm Type
Active Comparator
Arm Description
Subjects randomly selected for the no class group will not participate in the study exercise classes. Subjects will still complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up.
Intervention Type
Behavioral
Intervention Name(s)
Spinning Class
Intervention Description
Spinning Class twice a week for six weeks.
Intervention Type
Behavioral
Intervention Name(s)
Yoga Class
Intervention Description
Yoga Class twice a week for six weeks.
Intervention Type
Behavioral
Intervention Name(s)
Dance Class
Intervention Description
Dance Class twice a week for six weeks.
Intervention Type
Other
Intervention Name(s)
No Exercise Class
Intervention Description
No exercise class. Subject will continue regular activities for six weeks.
Primary Outcome Measure Information:
Title
Change from baseline, if any, in subjects' Fatigue Severity Scale
Description
Subjects will complete the Fatigue Severity Scale at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end.
Time Frame
screening through study completion, up to 18 weeks
Title
Change from baseline, if any, in subjects' Zung self-report Anxiety Scale
Description
Subjects will complete the Zung self-report Anxiety Scale at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end.
Time Frame
screening through study completion, up to 18 weeks
Title
Change from baseline, if any, in subjects' Beck Depression Inventory II scale
Description
Subjects will complete the Beck Depression Inventory II at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end.
Time Frame
screening through study completion, up to 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects diagnosed with Idiopathic Parkinson's Disease Age between 18 - 75 years Hoehn and Yahr stage less than or equal to 3 Mini-Mental State Exam (MMSE) score of over 23 at screening If subjects are taking any medications for depression, fatigue, or anxiety, regimen must be stable for 8 weeks prior to baseline visit Subjects willing and able to give informed consent Exclusion Criteria: Subjects with a diagnosis of an atypical Parkinsonism Subjects unwilling or unable to obtain Health Waiver from Primary Care Provider Score of 60 or more on UPDRS III at screening Scores in the 'normal' range on all three study assessments: Beck Depression Index II, Fatigue Severity Scale, and Zung self-rating Anxiety Scale Participation in any of the 3 physical activities more than 3 times in the past for 8 weeks prior to baseline Any other reason that, in the investigator's opinion, would exclude the subject from participation in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Feldman, DO
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease

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