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

Parkinson Disease Clinical Trial

— PDExercise  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03833349
• Other study ID #: 06538
• Status: Completed
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: October 2, 2019

Study information

• Verified date: March 2020
• Source: Premier Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2, 2019
• Est. primary completion date: October 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Fatigue
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
United States	Premier Health	Dayton	Ohio
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
Premier Health	Dartmouth-Hitchcock Medical Center, Parkinson's Disease Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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