Parkinson DiseaseNCT03463330
Benefits of Mild Body Exercises in Parkinson's Disease
A study testing Qigong exercise and Mild body exercise in people with Parkinson Disease, run by University of Kansas Medical Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Qigong exercise and Mild body exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2017to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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).
- Conditions
- Parkinson Disease
- Being tested
- Qigong exercise, Mild body exercise
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qigong exerciseBehavioural
The Qigong exercise is a series of mild exercise movements.
Mild body exerciseBehavioural
Participants will be taught of series of similar movements to the Qigong exercise.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Qigong exercise |
| Control Group | Sham comparator | 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. Receives: Behavioral: Mild body exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to Week 12
Secondary outcomes (13)
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.
Measured: Change from Baseline to Week 12
Non Motor Symptom Questionnaire (NMSQuest)
This instrument has a total range of scores between 0 and 30. The lower the score the better.
Measured: Change from Baseline to Week 12
Geriatric Anxiety Scale (GAS-10)
This instrument has a total range of scores between 0 and 30. The lower the score the better.
Measured: Change from Baseline to Week 12
Geriatric Depression Scale (GDS-15)
This instrument has a total range of scores between 0 and 15. The lower the score the better.
Measured: Change from Baseline to Week 12
Parkinson Fatigue Scale (PFS-16)
This instrument has a total range of scores between 16 and 90. The lower the score the better.
Measured: Change from Baseline to Week 12
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.
Measured: Change from Baseline to Week 12
Frontal Assessment Battery (FAB-18)
This instrument has a total range of scores between 0 and 18. The higher the score the better.
Measured: Change from Baseline to Week 12
Trail Making Test parts A
This test examines the time required to complete a task of connecting numbers in ascending sequence.
Measured: Change from Baseline to Week 12
Trail Making Test parts B
This test examines the required time for completing a task of connecting numbers and letters in ascending sequence.
Measured: Change from Baseline to Week 12
Unified Parkinson Disease Rating Scale (UPDRS)
This instrument has a total range of scores between 0 and 199. The lower the score the better.
Measured: Change from Baseline to Week 12
IL-1beta
Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).
Measured: Change from Baseline to Week 12
IL-6
Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).
Measured: Change from Baseline to Week 12
TNF-alpha
Serum biomarker will be measured by Enzyme Linked Immuno-Sorbent Assay (ELISA).
Measured: Change from Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start5 Jul 2017
- Primary completionFeb 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Qigong exercise in intervention arm and mild body exercise in control arm
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Liu, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463330
- Sponsor's protocol ID
- STUDY00140835
- Status last verified
- Jan 2022
- First submitted
- 6 Mar 2018
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share all IPD data that underlie results in our publications.
Publications
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.
PubMed 32631594Moon 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.
PubMed 30669324Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Mild Body Exercises in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03463330
- Acronym / sponsor ID
- STUDY00140835
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Qigong exercise in intervention arm and mild body exercise in control arm
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Qigong exerciseParticipation 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 | Sham comparator | Behavioral: Mild body exerciseParticipation 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. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qigong exerciseThe Qigong exercise is a series of mild exercise movements. | Behavioural | Intervention Group |
| Mild body exerciseParticipants will be taught of series of similar movements to the Qigong exercise. | Behavioural | Control Group |
Primary outcome
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.
13 secondary outcomes
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: Change from Baseline to Week 12
Non Motor Symptom Questionnaire (NMSQuest)
Time frame: Change from Baseline to Week 12
Geriatric Anxiety Scale (GAS-10)
Time frame: Change from Baseline to Week 12
Geriatric Depression Scale (GDS-15)
Time frame: Change from Baseline to Week 12
Parkinson Fatigue Scale (PFS-16)
Time frame: Change from Baseline to Week 12
Parkinson's Disease-Cognitive Rating Scale (PD-CRS)
Time frame: Change from Baseline to Week 12
Frontal Assessment Battery (FAB-18)
Time frame: Change from Baseline to Week 12
Trail Making Test parts A
Time frame: Change from Baseline to Week 12
Trail Making Test parts B
Time frame: Change from Baseline to Week 12
Unified Parkinson Disease Rating Scale (UPDRS)
Time frame: Change from Baseline to Week 12
IL-1beta
Time frame: Change from Baseline to Week 12
IL-6
Time frame: Change from Baseline to Week 12
TNF-alpha
Time frame: Change from Baseline to Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Background: PubMed 32631594Moon 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.
- Background: PubMed 30669324Moon 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.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
- The shared IPD will be accessible to researchers on our lab webpage.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. We will share all IPD data that underlie results in our publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen Liu, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qigong exercise and Mild body exercise in people with Parkinson Disease, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parkinson's Disease Sleep Scale (PDSS-2) (time frame: Change from Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03463330, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.