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

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ClinicalTrials.gov Identifier: NCT03833349
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : February 11, 2019
Sponsor:
Collaborators:
Parkinson's Disease Foundation
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Premier Health

Tracking Information
First Submitted Date  ICMJE February 5, 2019
First Posted Date  ICMJE February 7, 2019
Last Update Posted Date February 11, 2019
Estimated Study Start Date  ICMJE February 11, 2019
Estimated Primary Completion Date October 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
  • 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. Each item is scored from 1(strongly disagree) to 7(strongly agree).
  • 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. 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 [ 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. Each item is scored from 0(Normal) to 3(Severe).
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
  • 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.
  • 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.
  • 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.
Change History Complete list of historical versions of study NCT03833349 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease
Official Title  ICMJE The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Behavioral: Spinning Class
    Spinning Class twice a week for six weeks.
  • Behavioral: Yoga Class
    Yoga Class twice a week for six weeks.
  • Behavioral: Dance Class
    Dance Class twice a week for six weeks.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Spinning Class
  • 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.
    Intervention: Behavioral: Yoga Class
  • 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.
    Intervention: Behavioral: Dance Class
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2, 2019
Estimated Primary Completion Date October 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mary Feldman, DO (937) 438-7500 msfeldman@premierhealth.com
Contact: Ashley Paul, MD ampaul@premierhealth.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03833349
Other Study ID Numbers  ICMJE 06538
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Premier Health
Study Sponsor  ICMJE Premier Health
Collaborators  ICMJE
  • Parkinson's Disease Foundation
  • Dartmouth-Hitchcock Medical Center
Investigators  ICMJE
Principal Investigator: Mary Feldman, DO Premier Health
PRS Account Premier Health
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP