Clinical trial NCT03833349: The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease
Official title: The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's disease
fatigue
anxiety
depression
exercise
Lead sponsor: Premier Health
Sponsor class: OTHER
Collaborators: name: Parkinson's Disease Foundation
name: Dartmouth-Hitchcock Medical Center
First posted: 2019-02-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline, if any, in subjects' Fatigue Severity Scale
timeFrame: screening through study completion, up to 18 weeks
measure: Change from baseline, if any, in subjects' Zung self-report Anxiety Scale
timeFrame: screening through study completion, up to 18 weeks
measure: Change from baseline, if any, in subjects' Beck Depression Inventory II scale
timeFrame: screening through study completion, up to 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Dayton
country: United States
facility: Premier Health
state: Ohio
Study officials:
affiliation: Premier Health
name: Mary Feldman, DO
role: PRINCIPAL_INVESTIGATOR
References: