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Trial record 1 of 1 for:    NCT02885285
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The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease (PD&Exercise)

This study has been terminated.
(Recruitment goal not met)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02885285
First Posted: August 31, 2016
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Parkinson's Disease Foundation
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
  Purpose
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 Intervention
Parkinson's Disease Behavioral: Spinning Class Behavioral: Yoga Class Behavioral: Dance Class Other: No Exercise Class

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • 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.


Enrollment: 2
Study Start Date: August 2016
Study Completion Date: February 24, 2017
Primary Completion Date: February 24, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other: No Exercise Class
No exercise class. Subject will continue regular activities for six weeks.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
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): NCT02885285


Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Parkinson's Disease Foundation
Investigators
Principal Investigator: Mary Feldman, DO Dartmouth-Hitchcock Medical Center
  More Information

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02885285     History of Changes
Other Study ID Numbers: AWD00010460
First Submitted: August 24, 2016
First Posted: August 31, 2016
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dartmouth-Hitchcock Medical Center:
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