Benefits of Mild Body Exercises in Parkinson's Disease

NCT ID: NCT03463330

Last Updated: 2022-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-05

Study Completion Date

2022-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Qigong exercise in intervention arm and mild body exercise in control arm
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Qigong exercise

Intervention Type BEHAVIORAL

The Qigong exercise is a series of mild exercise movements.

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.

Group Type SHAM_COMPARATOR

Mild body exercise

Intervention Type BEHAVIORAL

Participants will be taught of series of similar movements to the Qigong exercise.

Interventions

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Qigong exercise

The Qigong exercise is a series of mild exercise movements.

Intervention Type BEHAVIORAL

Mild body exercise

Participants will be taught of series of similar movements to the Qigong exercise.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wen Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 32631594 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30669324 (View on PubMed)

Ernst 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.

Reference Type DERIVED
PMID: 38588457 (View on PubMed)

Ernst 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.

Reference Type DERIVED
PMID: 36602886 (View on PubMed)

Related Links

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Other Identifiers

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STUDY00140835

Identifier Type: -

Identifier Source: org_study_id

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