Benefits of Mild Body Exercises in Parkinson's Disease

NCT03463330 | Unknown

• 1 other identifier: STUDY00140835
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Parkinson's Disease Questionnaire (PDQ-39)

  Change from Baseline to Week 12

• Non Motor Symptom Questionnaire (NMSQuest)

  Change from Baseline to Week 12

• Geriatric Anxiety Scale (GAS-10)

  Change from Baseline to Week 12

• Geriatric Depression Scale (GDS-15)

  Change from Baseline to Week 12

• Parkinson Fatigue Scale (PFS-16)

  Change from Baseline to Week 12

Study Arms (2)

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.

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.

Behavioral: Mild body exercise

Interventions

Qigong exercise BEHAVIORAL

The Qigong exercise is a series of mild exercise movements.

Intervention Group

Mild body exercise BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (4)

• 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.

  PMID: 32631594 BACKGROUND

• 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.

  PMID: 30669324 BACKGROUND

• 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.

  PMID: 38588457 DERIVED

• 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.

  PMID: 36602886 DERIVED

Related Links

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

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Wen Liu, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Qigong exercise in intervention arm and mild body exercise in control arm

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 13, 2018
• Study Start: July 5, 2017
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The shared information will be available in our lab webpage 6 months after publication.
• 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.

Locations

US (1)