Qigong for Multiple Sclerosis: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility Outcome 1: Number of participants recruited for the study
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Qigong Intervention
60-90 minute community qigong classes, once per week plus at least 10 minutes of home practice
干预措施: Qigong (Other)
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.
结局指标
主要结局
Feasibility Outcome 1: Number of participants recruited for the study
时间窗: 8 months
Ability to recruit and enroll 20 participants with multiple sclerosis (MS) within 8 months.
Feasibility Outcome 2: Number of participants retained in the study
时间窗: 10 weeks
Goal to retain 80 percent of participants in the trial.
Feasibility Outcome 4: Percent attendance in qigong classes
时间窗: 10 weeks
Class attendance measured by self-report in exit survey and tracked by qigong instructor, with the goal of 70 percent attendance in class.
Feasibility Outcome 3: Percent able to participate in qigong classes
时间窗: 10 weeks
Participation based on participants' subjective report at week 1, 2, 7 phone check-ins and exit survey. Participants select from the following options: full participation, partial, a little, or none.
次要结局
- Clinical Measure 1: Walking speed assessed by the Timed-25-Foot-Walk Test(Baseline and 10 weeks)
- Clinical Measure 2: Mobility, balance and walking ability assessed by the Timed-Up-and-Go Test(Baseline and 10 weeks)
- Clinical Measure 5: Impact of multiple sclerosis on walking ability assessed by the Multiple Sclerosis Walking Scale (MSWS-12)(Baseline and 10 weeks)
- Clinical Measure 8: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System physical function (v1.2)(Baseline and 10 weeks)
- Clinical Measure 6: Fatigue assessed by the Modified Fatigue Impact Scale Short Version (MFIS-5)(Baseline and 10 weeks)
- Clinical Measure 9: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System fatigue (v1.0)(Baseline and 10 weeks)
- Clinical Measure 10: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System anxiety (v1.0)(Baseline and 10 weeks)
- Clinical Measure 3: Multidirectional mobility assessed by the Four-Square-Step-Test(Baseline and 10 weeks)
- Clinical Measure 7: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System global heath (mental and physical, v1.1)(Baseline and 10 weeks)
- Clinical Measure 4: Physical and psychological well-being assessed by the Multiple Sclerosis Impact Scale (MSIS-29)(Baseline and 10 weeks)
- Clinical Measure 11: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System depression (v1.0)(Baseline and 10 weeks)