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Benefits of Mild Body Exercises in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Qigong exercise
Mild body exercise
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Non Motor Symptom Questionnaire (NMSQuest)
This instrument has a total range of scores between 0 and 30. The lower the score the better.
Geriatric Anxiety Scale (GAS-10)
This instrument has a total range of scores between 0 and 30. The lower the score the better.
Geriatric Depression Scale (GDS-15)
This instrument has a total range of scores between 0 and 15. The lower the score the better.
Parkinson Fatigue Scale (PFS-16)
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)
This instrument has a total range of scores between 0 and 134. The higher the score the better.
Frontal Assessment Battery (FAB-18)
This instrument has a total range of scores between 0 and 18. The higher the score the better.
Trail Making Test parts A
This test examines the time required to complete a task of connecting numbers in ascending sequence.
Trail Making Test parts B
This test examines the required time for completing a task of connecting numbers and letters in ascending sequence.
Unified Parkinson Disease Rating Scale (UPDRS)
This instrument has a total range of scores between 0 and 199. The lower the score the better.
IL-1beta
Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).
IL-6
Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).
TNF-alpha
Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).

Full Information

First Posted
March 6, 2018
Last Updated
January 5, 2022
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03463330
Brief Title
Benefits of Mild Body Exercises in Parkinson's Disease
Official Title
Benefits of Mild Body Exercises in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 5, 2017 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Qigong exercise in intervention arm and mild body exercise in control arm
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Qigong exercise
Intervention Description
The Qigong exercise is a series of mild exercise movements.
Intervention Type
Behavioral
Intervention Name(s)
Mild body exercise
Intervention Description
Participants will be taught of series of similar movements to the Qigong exercise.
Primary Outcome Measure Information:
Title
Parkinson's Disease Sleep Scale (PDSS-2)
Description
This instrument has a total range of scores between 0 and 60. The lower the score the better.
Time Frame
Change from Baseline to Week 12
Secondary Outcome Measure Information:
Title
Parkinson's Disease Questionnaire (PDQ-39)
Description
Measure of quality of life. This instrument has a total range of scores between 0 and 156. The lower the score the better.
Time Frame
Change from Baseline to Week 12
Title
Non Motor Symptom Questionnaire (NMSQuest)
Description
This instrument has a total range of scores between 0 and 30. The lower the score the better.
Time Frame
Change from Baseline to Week 12
Title
Geriatric Anxiety Scale (GAS-10)
Description
This instrument has a total range of scores between 0 and 30. The lower the score the better.
Time Frame
Change from Baseline to Week 12
Title
Geriatric Depression Scale (GDS-15)
Description
This instrument has a total range of scores between 0 and 15. The lower the score the better.
Time Frame
Change from Baseline to Week 12
Title
Parkinson Fatigue Scale (PFS-16)
Description
This instrument has a total range of scores between 16 and 90. The lower the score the better.
Time Frame
Change from Baseline to Week 12
Title
Parkinson's Disease-Cognitive Rating Scale (PD-CRS)
Description
This instrument has a total range of scores between 0 and 134. The higher the score the better.
Time Frame
Change from Baseline to Week 12
Title
Frontal Assessment Battery (FAB-18)
Description
This instrument has a total range of scores between 0 and 18. The higher the score the better.
Time Frame
Change from Baseline to Week 12
Title
Trail Making Test parts A
Description
This test examines the time required to complete a task of connecting numbers in ascending sequence.
Time Frame
Change from Baseline to Week 12
Title
Trail Making Test parts B
Description
This test examines the required time for completing a task of connecting numbers and letters in ascending sequence.
Time Frame
Change from Baseline to Week 12
Title
Unified Parkinson Disease Rating Scale (UPDRS)
Description
This instrument has a total range of scores between 0 and 199. The lower the score the better.
Time Frame
Change from Baseline to Week 12
Title
IL-1beta
Description
Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).
Time Frame
Change from Baseline to Week 12
Title
IL-6
Description
Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).
Time Frame
Change from Baseline to Week 12
Title
TNF-alpha
Description
Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).
Time Frame
Change from Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Liu, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share all IPD data that underlie results in our publications.
IPD Sharing Time Frame
The shared information will be available in our lab webpage 6 months after publication.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://www.kumc.edu/school-of-health-professions/academics/departments/physical-therapy-rehabilitation-science-and-athletic-training/research/neuromuscular-research-laboratory.html
Citations:
PubMed Identifier
32631594
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.
Results Reference
background
PubMed Identifier
30669324
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.
Results Reference
background
Links:
URL
https://www.kumc.edu/school-of-health-professions/academics/departments/physical-therapy-rehabilitation-science-and-athletic-training/research/neuromuscular-research-laboratory.html
Description
The shared IPD will be accessible to researchers on our lab webpage.

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Benefits of Mild Body Exercises in Parkinson's Disease

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