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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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. |
|
| Control Group | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qigong exercise | Behavioral | The Qigong exercise is a series of mild exercise movements. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wen Liu, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32631594 | Background | 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. No abstract available. | |
| 30669324 | Background | 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):13. doi: 10.3390/medicines6010013. |
| Label | URL |
|---|---|
| The shared IPD will be accessible to researchers on our lab webpage. | View source |
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We will share all IPD data that underlie results in our publications.
The shared information will be available in our lab webpage 6 months after publication.
The data will be shared with researchers who plan to conduct meta analysis. The PI will review any request for data sharing and make decisions on data sharing.
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Qigong exercise in intervention arm and mild body exercise in control arm
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| Mild body exercise | Behavioral | Participants will be taught of series of similar movements to the Qigong exercise. |
|
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 |
| 38588457 | Derived | Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3. |
| 36602886 | Derived | Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |