Benefits of Mild Body Exercises in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Benefits of Mild Body Exercises in Parkinson's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03463330
• Other study ID #: STUDY00140835
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 5, 2017
• Est. completion date: March 2022

Study information

• Verified date: January 2022
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: March 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Qigong exercise
The Qigong exercise is a series of mild exercise movements.
• Mild body exercise
Participants will be taught of series of similar movements to the Qigong exercise.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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). pii: E13. doi: 10.3390/medicines6010013. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Non Motor Symptom Questionnaire (NMSQuest)	This instrument has a total range of scores between 0 and 30. The lower the score the better.	Change from Baseline to Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	IL-1beta	Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).	Change from Baseline to Week 12
Secondary	IL-6	Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).	Change from Baseline to Week 12
Secondary	TNF-alpha	Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).	Change from Baseline to Week 12

External Links

•   The shared IPD will be accessible to researchers on our lab webpage.