Clinical trial NCT03463330: Benefits of Mild Body Exercises in Parkinson's Disease
Official title: Benefits of Mild Body Exercises in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 65
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Qigong exercise in intervention arm and mild body exercise in control arm
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Parkinson's Disease Sleep Scale (PDSS-2)
timeFrame: Change from Baseline to Week 12
Secondary outcomes:
measure: Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Change from Baseline to Week 12
measure: Non Motor Symptom Questionnaire (NMSQuest)
timeFrame: Change from Baseline to Week 12
measure: Geriatric Anxiety Scale (GAS-10)
timeFrame: Change from Baseline to Week 12
measure: Geriatric Depression Scale (GDS-15)
timeFrame: Change from Baseline to Week 12
measure: Parkinson Fatigue Scale (PFS-16)
timeFrame: Change from Baseline to Week 12
measure: Parkinson's Disease-Cognitive Rating Scale (PD-CRS)
timeFrame: Change from Baseline to Week 12
measure: Frontal Assessment Battery (FAB-18)
timeFrame: Change from Baseline to Week 12
measure: Trail Making Test parts A
timeFrame: Change from Baseline to Week 12
measure: Trail Making Test parts B
timeFrame: Change from Baseline to Week 12
measure: Unified Parkinson Disease Rating Scale (UPDRS)
timeFrame: Change from Baseline to Week 12
measure: IL-1beta
timeFrame: Change from Baseline to Week 12
measure: IL-6
timeFrame: Change from Baseline to Week 12
measure: TNF-alpha
timeFrame: Change from Baseline to Week 12
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Wen Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.