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

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: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Spinning Class; Behavioral: Yoga Class; Behavioral: Dance Class

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
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • Ohio
    • Dayton, Ohio, United States, 45409
      • Premier Health

Participation Criteria

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline, if any, in subjects' Fatigue Severity Scale	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).	screening through study completion, up to 18 weeks
Change from baseline, if any, in subjects' Zung self-report Anxiety Scale	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).	screening through study completion, up to 18 weeks
Change from baseline, if any, in subjects' Beck Depression Inventory II scale	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).	screening through study completion, up to 18 weeks

Collaborators and Investigators

• Sponsor: Premier Health
• Collaborators: Dartmouth-Hitchcock Medical Center; Parkinson's Disease Foundation
• Investigators: Principal Investigator: Mary Feldman, DO, Premier Health

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2019
• Primary Completion (Actual): October 2, 2019
• Study Completion (Actual): October 2, 2019

Study Registration Dates

• First Submitted: February 5, 2019
• First Submitted That Met QC Criteria: February 5, 2019
• First Posted (Actual): February 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: fatigue; exercise; depression; anxiety; Parkinson's disease
• Additional Relevant MeSH Terms: Behavioral Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Depression; Fatigue; Parkinson Disease
• Other Study ID Numbers: 06538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No