Parkinson Disease
Conditions
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).
Interventions
BEHAVIORALQigong exercise
The Qigong exercise is a series of mild exercise movements.
BEHAVIORALMild body exercise
Participants will be taught of series of similar movements to the Qigong exercise.
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Qigong exercise in intervention arm and mild body exercise in control arm
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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. |
Countries
United States
Outcome results
None listed