Benefits of Mild Body Exercises in Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Behavioral: Qigong exerciseBehavioral: Mild body exercise
- Registration Number
- NCT03463330
- Lead Sponsor
- University of Kansas Medical Center
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 65
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Qigong exercise 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 Mild body exercise 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
IL-1beta 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.
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.
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.
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.
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.
IL-6 Change from Baseline to Week 12 Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States