Parkinson Disease
Conditions
Keywords
Parkinson's disease, fatigue, anxiety, depression, exercise
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.
Interventions
BEHAVIORALSpinning Class
Spinning Class twice a week for six weeks.
BEHAVIORALYoga Class
Yoga Class twice a week for six weeks.
BEHAVIORALDance Class
Dance Class twice a week for six weeks.
Sponsors
Parkinson's Disease Foundation
Dartmouth-Hitchcock Medical Center
Premier Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline, if any, in subjects' Fatigue Severity Scale | screening through study completion, up to 18 weeks | 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). |
| Change from baseline, if any, in subjects' Zung self-report Anxiety Scale | screening through study completion, up to 18 weeks | 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). |
| Change from baseline, if any, in subjects' Beck Depression Inventory II scale | screening through study completion, up to 18 weeks | 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). |
Countries
United States
Outcome results
None listed