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
COMPLETED
Clinical Phase
NA
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-02-01
Study Completion Date
2018-03-16
Brief Summary
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This feasibility study explores a community-based qigong intervention for people with multiple sclerosis (MS). The primary aim is to assess the feasibility of weekly community qigong classes for people with MS. The secondary aim is to explore the effects of qigong on balance, gait, mood, fatigue, and quality of life.
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Detailed Description
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Qigong, a traditional Chinese mind-body exercise, has been shown to improve balance and gait in several neurological conditions; however, community-delivered qigong has never been assessed for people with multiple sclerosis (MS). We assessed the feasibility of community qigong classes for people with MS and explored outcomes of balance, gait, and quality of life (QOL).
Twenty adults with MS were randomly assigned to 10 weeks of community qigong classes or wait-list control. Feasibility criteria included recruitment, retention, adherence, and ability to participate in qigong movements. Secondary outcome measures included physical tests of mobility, gait and balance, and participant-reported mobility, depression, anxiety, fatigue, and QOL.
Because this is a small feasibility study, the data collected are meant to be hypothesis-generating. Any clinically meaningful trends toward improvement will justify further exploration of qigong for MS in a larger clinical trial.
Twenty adults with MS were randomly assigned to 10 weeks of community qigong classes or wait-list control. Feasibility criteria included recruitment, retention, adherence, and ability to participate in qigong movements. Secondary outcome measures included physical tests of mobility, gait and balance, and participant-reported mobility, depression, anxiety, fatigue, and QOL.
Because this is a small feasibility study, the data collected are meant to be hypothesis-generating. Any clinically meaningful trends toward improvement will justify further exploration of qigong for MS in a larger clinical trial.
Conditions
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Multiple Sclerosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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Qigong Intervention
60-90 minute community qigong classes, once per week plus at least 10 minutes of home practice
Group Type
EXPERIMENTAL
Qigong
Intervention Type
OTHER
Mind-body movement art that includes specific movements, breath exercises, stretching and meditation.
Wait-List Control
Participants asked not to do any qigong, yoga or taichi for 10 weeks. Participants have the option to cross-over to the experimental arm after 10 weeks of no intervention.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Qigong
Mind-body movement art that includes specific movements, breath exercises, stretching and meditation.
Intervention Type
OTHER
Other Intervention Names
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Qi-gong
Eligibility Criteria
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Inclusion Criteria
* Living in the Portland Metropolitan Area
* Self-reported diagnosis of multiple sclerosis (MS - any type)
* Demonstrated ability to walk 50 feet without assistance
* Stable on disease-modifying or balance medications three months prior to baseline
* Self-reported diagnosis of multiple sclerosis (MS - any type)
* Demonstrated ability to walk 50 feet without assistance
* Stable on disease-modifying or balance medications three months prior to baseline
Exclusion Criteria
* Pregnant or nursing
* Participated in qigong, tai chi, or yoga (\>1 month) within six months prior to baseline
* Had an MS relapse within 30 days prior to baseline.
* Participated in qigong, tai chi, or yoga (\>1 month) within six months prior to baseline
* Had an MS relapse within 30 days prior to baseline.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National University of Natural Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Angela Senders, ND, MCR
Role: PRINCIPAL_INVESTIGATOR
Research Investigator and Assistant Professor
Locations
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National University of Natural Medicine, Helfgott Research Institute
Portland, Oregon, United States
Site Status
Countries
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United States
References
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RESULT
Nilsagard Y, Gunn H, Freeman J, Hoang P, Lord S, Mazumder R, Cameron M. Falls in people with MS--an individual data meta-analysis from studies from Australia, Sweden, United Kingdom and the United States. Mult Scler. 2015 Jan;21(1):92-100. doi: 10.1177/1352458514538884. Epub 2014 Jun 16.
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RESULT
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RESULT
Fischer M, Fugate-Woods N, Wayne PM. Use of pragmatic community-based interventions to enhance recruitment and adherence in a randomized trial of Tai Chi for women with osteopenia: insights from a qualitative substudy. Menopause. 2014 Nov;21(11):1181-9. doi: 10.1097/GME.0000000000000257.
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RESULT
Motl RW, Cohen JA, Benedict R, Phillips G, LaRocca N, Hudson LD, Rudick R; Multiple Sclerosis Outcome Assessments Consortium. Validity of the timed 25-foot walk as an ambulatory performance outcome measure for multiple sclerosis. Mult Scler. 2017 Apr;23(5):704-710. doi: 10.1177/1352458517690823. Epub 2017 Feb 16.
Reference Type
RESULT
Taylor E, Taylor-Piliae RE. The effects of Tai Chi on physical and psychosocial function among persons with multiple sclerosis: A systematic review. Complement Ther Med. 2017 Apr;31:100-108. doi: 10.1016/j.ctim.2017.03.001. Epub 2017 Mar 2.
Reference Type
RESULT
Buttolph L, Wooliscroft L, Bradley R, Zwickey H. Participant Perspectives on Community Qigong for People with Multiple Sclerosis. Integr Med Rep. 2023 Feb 1;2(1):26-34. doi: 10.1089/imr.2022.0079. Epub 2023 Feb 1.
Reference Type
DERIVED
Buttolph L, Corn J, Hanes D, Bradley R, Senders A. Community qigong for People with Multiple Sclerosis: A Pragmatic Feasibility Study. J Altern Complement Med. 2021 Jun;27(6):506-514. doi: 10.1089/acm.2020.0481. Epub 2021 Mar 26.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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https://www.nationalmssociety.org/What-is-MS/Definition-of-MS
Definition of Multiple Sclerosis
Other Identifiers
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102015
Identifier Type: -
Identifier Source: org_study_id
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