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

Study Overview
=================
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
-----------------
This is a multi-site trial (12 patients in each site). The investigators are recruiting 24 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. All participants will be asked to complete questionnaires each week and will be asked to wear a Microsoft exercise band during the course of the study. Use of the exercise band is optional.

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

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Behavioral: Spinning Class
* Behavioral: Yoga Class
* Behavioral: Dance Class


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinning Class<br>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. | Behavioral: Spinning Class<br>* Spinning Class twice a week for six weeks.<br>|
| Experimental: Yoga Class<br>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. | Behavioral: Yoga Class<br>* Yoga Class twice a week for six weeks.<br>|
| Experimental: Dance Class<br>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. | Behavioral: Dance Class<br>* Dance Class twice a week for six weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. Each item is scored from 1(strongly disagree) to 7(strongly agree). | screening through study completion, up to 18 weeks | 
| 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. Each item is scored from 1(a little of the time) to 4(most of the time). | screening through study completion, up to 18 weeks | 
| 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. Each item is scored from 0(Normal) to 3(Severe). | screening through study completion, up to 18 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, fatigue, anxiety, depression, exercise