Benefits of Mild Body Exercises in Parkinson's Disease

Study Overview
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Brief Summary
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The purpose of this study is to learn the effects of two mild body exercises on quality of life, non-motor symptoms, anxiety, depression, fatigue, sleep quality, cognition, and executive function on people with Parkinson's Disease (PD).

Official Title
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Benefits of Mild Body Exercises in Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: Qigong exercise
* Behavioral: Mild body exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of idiopathic PD Currently taking levodopa with some improvement in motor symptoms, and on a stable dose for a minimum of 4 weeks prior to starting the study Hoehn & Yahr stage I to III (mild to moderate PD) Exclusion Criteria: Mini Mental State Examination (MMSE) score < 24 Central neurological diseases other than PD or prior major head trauma with loss of consciousness, including other forms of parkinsonism, uncontrolled or significant cardiovascular diseases, orthopedic or medical problems that would interfere with gait Being primarily wheelchair bound Deep brain stimulation Expected change in PD medications over the course of the study Subjects with MRI contraindications such as pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Qigong exercise in intervention arm and mild body exercise in control arm
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Participation in the intervention group will involve a total of 14 visits over about 14 weeks to the study site, and then a 6-month follow-up evaluation. Participants will learn and practice the Qigong exercise during the study. | Behavioral: Qigong exercise<br>* The Qigong exercise is a series of mild exercise movements.<br>|
| Sham Comparator: Control Group<br>Participation in the intervention group will involve a total of 14 visits over about 14 weeks to the study site, and then a 6-month follow-up evaluation. Participants will learn and practice a mild body exercise during the study. | Behavioral: Mild body exercise<br>* Participants will be taught of series of similar movements to the Qigong exercise.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parkinson's Disease Sleep Scale (PDSS-2) | This instrument has a total range of scores between 0 and 60. The lower the score the better. | Change from Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parkinson's Disease Questionnaire (PDQ-39) | Measure of quality of life. This instrument has a total range of scores between 0 and 156. The lower the score the better. | Change from Baseline to Week 12 | 
| Non Motor Symptom Questionnaire (NMSQuest) | This instrument has a total range of scores between 0 and 30. The lower the score the better. | Change from Baseline to Week 12 | 
| Geriatric Anxiety Scale (GAS-10) | This instrument has a total range of scores between 0 and 30. The lower the score the better. | Change from Baseline to Week 12 | 
| Geriatric Depression Scale (GDS-15) | This instrument has a total range of scores between 0 and 15. The lower the score the better. | Change from Baseline to Week 12 | 
| Parkinson Fatigue Scale (PFS-16) | This instrument has a total range of scores between 16 and 90. The lower the score the better. | Change from Baseline to Week 12 | 
| Parkinson's Disease-Cognitive Rating Scale (PD-CRS) | This instrument has a total range of scores between 0 and 134. The higher the score the better. | Change from Baseline to Week 12 | 
| Frontal Assessment Battery (FAB-18) | This instrument has a total range of scores between 0 and 18. The higher the score the better. | Change from Baseline to Week 12 | 
| Trail Making Test parts A | This test examines the time required to complete a task of connecting numbers in ascending sequence. | Change from Baseline to Week 12 | 
| Trail Making Test parts B | This test examines the required time for completing a task of connecting numbers and letters in ascending sequence. | Change from Baseline to Week 12 | 
| Unified Parkinson Disease Rating Scale (UPDRS) | This instrument has a total range of scores between 0 and 199. The lower the score the better. | Change from Baseline to Week 12 | 
| IL-1beta | Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA). | Change from Baseline to Week 12 | 
| IL-6 | Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA). | Change from Baseline to Week 12 | 
| TNF-alpha | Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA). | Change from Baseline to Week 12 |