Benefits of Mild Body Exercises in Parkinson's Disease
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Group 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
The Qigong exercise is a series of mild exercise movements.
|
| Sham Comparator: Control Group 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
Participants will be taught of series of similar movements to the Qigong exercise.
|
Outcome Measures
Primary Outcome Measures
- Parkinson's Disease Sleep Scale (PDSS-2) [Change from Baseline to Week 12]
This instrument has a total range of scores between 0 and 60. The lower the score the better.
Secondary Outcome Measures
- Parkinson's Disease Questionnaire (PDQ-39) [Change from Baseline to Week 12]
Measure of quality of life. This instrument has a total range of scores between 0 and 156. The lower the score the better.
- Non Motor Symptom Questionnaire (NMSQuest) [Change from Baseline to Week 12]
This instrument has a total range of scores between 0 and 30. The lower the score the better.
- Geriatric Anxiety Scale (GAS-10) [Change from Baseline to Week 12]
This instrument has a total range of scores between 0 and 30. The lower the score the better.
- Geriatric Depression Scale (GDS-15) [Change from Baseline to Week 12]
This instrument has a total range of scores between 0 and 15. The lower the score the better.
- Parkinson Fatigue Scale (PFS-16) [Change from Baseline to Week 12]
This instrument has a total range of scores between 16 and 90. The lower the score the better.
- Parkinson's Disease-Cognitive Rating Scale (PD-CRS) [Change from Baseline to Week 12]
This instrument has a total range of scores between 0 and 134. The higher the score the better.
- Frontal Assessment Battery (FAB-18) [Change from Baseline to Week 12]
This instrument has a total range of scores between 0 and 18. The higher the score the better.
- Trail Making Test parts A [Change from Baseline to Week 12]
This test examines the time required to complete a task of connecting numbers in ascending sequence.
- Trail Making Test parts B [Change from Baseline to Week 12]
This test examines the required time for completing a task of connecting numbers and letters in ascending sequence.
- Unified Parkinson Disease Rating Scale (UPDRS) [Change from Baseline to Week 12]
This instrument has a total range of scores between 0 and 199. The lower the score the better.
- IL-1beta [Change from Baseline to Week 12]
Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).
- IL-6 [Change from Baseline to Week 12]
Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).
- TNF-alpha [Change from Baseline to Week 12]
Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of idiopathic PD
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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
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Hoehn & Yahr stage I to III (mild to moderate PD)
Exclusion Criteria:
-
Mini Mental State Examination (MMSE) score < 24
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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
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Being primarily wheelchair bound
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Deep brain stimulation
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Expected change in PD medications over the course of the study
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Subjects with MRI contraindications such as pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
Sponsors and Collaborators
- University of Kansas Medical Center
Investigators
- Principal Investigator: Wen Liu, PhD, University of Kansas Medical Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Moon S, Sarmento CVM, Colgrove Y, Liu W. Complementary Health Approaches for People With Parkinson Disease. Arch Phys Med Rehabil. 2020 Aug;101(8):1475-1477. doi: 10.1016/j.apmr.2020.03.024. Epub 2020 Jul 3.
- Moon S, Sarmento CVM, Smirnova IV, Colgrove Y, Lyons KE, Lai SM, Liu W. Effects of Qigong Exercise on Non-Motor Symptoms and Inflammatory Status in Parkinson's Disease: A Protocol for a Randomized Controlled Trial. Medicines (Basel). 2019 Jan 18;6(1). pii: E13. doi: 10.3390/medicines6010013.
- STUDY00140835