Clinical trial NCT04585659: Qigong for Multiple Sclerosis: A Feasibility Study
Official title: Qigong for Multiple Sclerosis: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Qigong
Pragmatic Design
Gait
Multiple Sclerosis
Lead sponsor: National University of Natural Medicine
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

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.

Primary outcomes:
measure: Feasibility Outcome 1: Number of participants recruited for the study
timeFrame: 8 months
measure: Feasibility Outcome 2: Number of participants retained in the study
timeFrame: 10 weeks
measure: Feasibility Outcome 3: Percent able to participate in qigong classes
timeFrame: 10 weeks
measure: Feasibility Outcome 4: Percent attendance in qigong classes
timeFrame: 10 weeks
Secondary outcomes:
measure: Clinical Measure 1: Walking speed assessed by the Timed-25-Foot-Walk Test
timeFrame: Baseline and 10 weeks
measure: Clinical Measure 2: Mobility, balance and walking ability assessed by the Timed-Up-and-Go Test
timeFrame: Baseline and 10 weeks
measure: Clinical Measure 3: Multidirectional mobility assessed by the Four-Square-Step-Test
timeFrame: Baseline and 10 weeks
measure: Clinical Measure 4: Physical and psychological well-being assessed by the Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: Baseline and 10 weeks
measure: Clinical Measure 5: Impact of multiple sclerosis on walking ability assessed by the Multiple Sclerosis Walking Scale (MSWS-12)
timeFrame: Baseline and 10 weeks
measure: Clinical Measure 6: Fatigue assessed by the Modified Fatigue Impact Scale Short Version (MFIS-5)
timeFrame: Baseline and 10 weeks
measure: Clinical Measure 7: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System global heath (mental and physical, v1.1)
timeFrame: Baseline and 10 weeks
measure: Clinical Measure 8: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System physical function (v1.2)
timeFrame: Baseline and 10 weeks
measure: Clinical Measure 9: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System fatigue (v1.0)
timeFrame: Baseline and 10 weeks
measure: Clinical Measure 10: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System anxiety (v1.0)
timeFrame: Baseline and 10 weeks
measure: Clinical Measure 11: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System depression (v1.0)
timeFrame: Baseline and 10 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: National University of Natural Medicine, Helfgott Research Institute
state: Oregon
Study officials:
affiliation: Research Investigator and Assistant Professor
name: Angela Senders, ND, MCR
role: PRINCIPAL_INVESTIGATOR
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