- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02885285
The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease (PD&Exercise)
July 25, 2017 updated by: Dartmouth-Hitchcock Medical Center
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Spinning Class
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.
|
Spinning Class twice a week for six weeks.
|
Experimental: Yoga Class
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.
|
Yoga Class twice a week for six weeks.
|
Experimental: Dance Class
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.
|
Dance Class twice a week for six weeks.
|
Active Comparator: No Exercise Class
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.
|
No exercise class.
Subject will continue regular activities for six weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline, if any, in subjects' Fatigue Severity Scale
Time Frame: 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.
|
screening through study completion, up to 18 weeks
|
Change from baseline, if any, in subjects' Zung self-report Anxiety Scale
Time Frame: 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.
|
screening through study completion, up to 18 weeks
|
Change from baseline, if any, in subjects' Beck Depression Inventory II scale
Time Frame: 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.
|
screening through study completion, up to 18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mary Feldman, DO, Dartmouth-Hitchcock Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Actual)
February 24, 2017
Study Completion (Actual)
February 24, 2017
Study Registration Dates
First Submitted
August 24, 2016
First Submitted That Met QC Criteria
August 30, 2016
First Posted (Estimate)
August 31, 2016
Study Record Updates
Last Update Posted (Actual)
July 26, 2017
Last Update Submitted That Met QC Criteria
July 25, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AWD00010460
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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