Benefits of Mild Body Exercises in Parkinson's Disease

January 5, 2022 updated by: University of Kansas Medical Center
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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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.
Behavioral: Qigong exercise
The Qigong exercise is a series of mild exercise movements.
Sham Comparator: Control Group
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.
Behavioral: Mild body exercise
Participants will be taught of series of similar movements to the Qigong exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parkinson's Disease Sleep Scale (PDSS-2)
Time Frame: Change from Baseline to Week 12
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parkinson's Disease Questionnaire (PDQ-39)
Time Frame: 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.
Change from Baseline to Week 12
Non Motor Symptom Questionnaire (NMSQuest)
Time Frame: Change from Baseline to Week 12
This instrument has a total range of scores between 0 and 30. The lower the score the better.
Change from Baseline to Week 12
Geriatric Anxiety Scale (GAS-10)
Time Frame: Change from Baseline to Week 12
This instrument has a total range of scores between 0 and 30. The lower the score the better.
Change from Baseline to Week 12
Geriatric Depression Scale (GDS-15)
Time Frame: Change from Baseline to Week 12
This instrument has a total range of scores between 0 and 15. The lower the score the better.
Change from Baseline to Week 12
Parkinson Fatigue Scale (PFS-16)
Time Frame: Change from Baseline to Week 12
This instrument has a total range of scores between 16 and 90. The lower the score the better.
Change from Baseline to Week 12
Parkinson's Disease-Cognitive Rating Scale (PD-CRS)
Time Frame: Change from Baseline to Week 12
This instrument has a total range of scores between 0 and 134. The higher the score the better.
Change from Baseline to Week 12
Frontal Assessment Battery (FAB-18)
Time Frame: Change from Baseline to Week 12
This instrument has a total range of scores between 0 and 18. The higher the score the better.
Change from Baseline to Week 12
Trail Making Test parts A
Time Frame: Change from Baseline to Week 12
This test examines the time required to complete a task of connecting numbers in ascending sequence.
Change from Baseline to Week 12
Trail Making Test parts B
Time Frame: Change from Baseline to Week 12
This test examines the required time for completing a task of connecting numbers and letters in ascending sequence.
Change from Baseline to Week 12
Unified Parkinson Disease Rating Scale (UPDRS)
Time Frame: Change from Baseline to Week 12
This instrument has a total range of scores between 0 and 199. The lower the score the better.
Change from Baseline to Week 12
IL-1beta
Time Frame: Change from Baseline to Week 12
Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).
Change from Baseline to Week 12
IL-6
Time Frame: Change from Baseline to Week 12
Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).
Change from Baseline to Week 12
TNF-alpha
Time Frame: Change from Baseline to Week 12
Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).
Change from Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Wen Liu, PhD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2017

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

March 6, 2018

First Submitted That Met QC Criteria

March 6, 2018

First Posted (Actual)

March 13, 2018

Study Record Updates

Last Update Posted (Actual)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00140835

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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 Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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