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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

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: Spinning Class Behavioral: Yoga Class Behavioral: Dance Class Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease
Estimated Study Start Date : February 11, 2019
Estimated Primary Completion Date : October 2, 2019
Estimated Study Completion Date : October 2, 2019

Resource links provided by the National Library of Medicine


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.
Behavioral: Spinning Class
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.
Behavioral: Yoga Class
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.
Behavioral: Dance Class
Dance Class twice a week for six weeks.




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833349


Contacts
Contact: Mary Feldman, DO (937) 438-7500 msfeldman@premierhealth.com
Contact: Ashley Paul, MD ampaul@premierhealth.com

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Stephen L. Lee, MD, PhD    603-650-5104      
United States, Ohio
Premier Health Recruiting
Dayton, Ohio, United States, 45409
Contact: Mary Feldman, DO         
Principal Investigator: Mary Feldman, DO         
Sub-Investigator: Ashley Paul, MD         
Sponsors and Collaborators
Premier Health
Parkinson's Disease Foundation
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Mary Feldman, DO Premier Health

Responsible Party: Premier Health
ClinicalTrials.gov Identifier: NCT03833349     History of Changes
Other Study ID Numbers: 06538
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Premier Health:
Parkinson's disease
fatigue
anxiety
depression
exercise

Additional relevant MeSH terms:
Depression
Parkinson Disease
Fatigue
Behavioral Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Signs and Symptoms