Qigong for Multiple Sclerosis: A Feasibility Study

October 12, 2020 updated by: National University of Natural Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97201
        • National University of Natural Medicine, Helfgott Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Qigong Intervention
60-90 minute community qigong classes, once per week plus at least 10 minutes of home practice
Other: Qigong
Mind-body movement art that includes specific movements, breath exercises, stretching and meditation.
Other Names:
  • Qi-gong
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility Outcome 1: Number of participants recruited for the study
Time Frame: 8 months
Ability to recruit and enroll 20 participants with multiple sclerosis (MS) within 8 months.
8 months
Feasibility Outcome 2: Number of participants retained in the study
Time Frame: 10 weeks
Goal to retain 80 percent of participants in the trial.
10 weeks
Feasibility Outcome 3: Percent able to participate in qigong classes
Time Frame: 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.
10 weeks
Feasibility Outcome 4: Percent attendance in qigong classes
Time Frame: 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.
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Measure 1: Walking speed assessed by the Timed-25-Foot-Walk Test
Time Frame: Baseline and 10 weeks
The Timed-25-Foot-Walk (T25FW) reliably measures walking ability for people with MS, and has a high test-retest reliability (intraclass correlation coefficient (ICC) of 0.99). The test is administered and rated by a trained examiner, and consists of having the participant walk a 25-foot long course as quickly as safely possible while being timed. Once the subject reaches the end-point, he/she is asked to turn around and walk back through the course, also while being timed. The score is an average of the time needed to complete each of the two trials. Lower scores indicate faster walking ability.
Baseline and 10 weeks
Clinical Measure 2: Mobility, balance and walking ability assessed by the Timed-Up-and-Go Test
Time Frame: Baseline and 10 weeks
The Timed-Up-and-Go tests muscle function and mobility, predicts safe walking ability, and correlates with other mobility tests (r=0.81 correlation with Berg Balance Scale, r=-0.61 for gait speed). The test begins with the participant sitting in an armchair with his/her back resting on the back of the chair and arms resting on the arms of the chair. The participant is then asked to stand up and walk 3 m at a comfortable and safe speed, turn around, walk back and return to a seated position. The time that it takes to complete this exercise is then recorded. Lower scores indicate faster walking ability.
Baseline and 10 weeks
Clinical Measure 3: Multidirectional mobility assessed by the Four-Square-Step-Test
Time Frame: Baseline and 10 weeks
The Four-Square-Step-Test is a validated measure of multi-directional mobility for MS, with high interrater (ICC=0.99) and retest reliability (ICC=0.98). The test measures a person's ability to step over objects in four directions. We created 4 3-ft boxes on the floor using colored masking tape. Participants are asked to step from the first box forward to the second, then right to square 3, back to square 4, and left to square 1, and then go back in the opposite order (4 to 3 to 2 to 1) while being timed. The participant is allowed practice this sequence before being timed. The test is repeated twice, with the best time taken as the score. Lower scores indicate greater multi-directional mobility.
Baseline and 10 weeks
Clinical Measure 4: Physical and psychological well-being assessed by the Multiple Sclerosis Impact Scale (MSIS-29)
Time Frame: Baseline and 10 weeks
The Multiple Sclerosis Impact Scale (MSIS-29) is a validated core outcome measure that allows people with multiple sclerosis (MS) to self-assess the impact of MS on their physical and psychological well-being. This scale is commonly used to assess quality of life in studies of exercise and MS. The MSIS-29 was developed in 2000 as a patient-administered survey for MS, and includes 20 questions on physical impacts and 9 questions on psychological impacts of MS.55 The MSIS scales have good variability, small floor-to-ceiling effects, high internal consistency (Cronbach's alpha < 0.91), and high test-retest reliability (intraclass correlation > 0.87). Scores are adjusted to a 0 (min) to100 (max) scale. Higher scores indicate a worsening or more severe impact of MS on a person's physical and/or psychological condition.
Baseline and 10 weeks
Clinical Measure 5: Impact of multiple sclerosis on walking ability assessed by the Multiple Sclerosis Walking Scale (MSWS-12)
Time Frame: Baseline and 10 weeks
The MS Walking Scale is a 12-question self-reported measure of impact of MS on walking ability. The test has good test-retest reliability (intraclass correlation > 0.78), and high internal consistency, criterion validity, and reliability (> 0.94). We included this measure to complement the physical tests on balance and gait. Scores are adjusted to a 0-100 scale. Higher scores indicate a greater impact of MS on walking ability (i.e., more difficulty walking).
Baseline and 10 weeks
Clinical Measure 6: Fatigue assessed by the Modified Fatigue Impact Scale Short Version (MFIS-5)
Time Frame: Baseline and 10 weeks
The Modified Fatigue Impact Scale (MFIS) has been recommended by the ICM as a measure of energy and drive. The measure assesses physical, cognitive and psychosocial aspects of fatigue, and has a high internal consistency (Cronbach's alpha of 0.80). The 5-item version takes 2 minutes to complete, has an adequate test-retest reliability (r=0.76), and has been shown to capture meaningful changes in fatigue. Scores range from 0-20. Higher scores indicate higher levels of fatigue.
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)
Time Frame: Baseline and 10 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) are patient reported outcome surveys developed by the National Institutes for Health. The minimum raw score is 4, and maximum is 20. Raw scores are converted to standardized T-scores relative to a population mean of 50 and SD of 10 (T-scores range from 16.2 (minimum) to 67.7 (maximum) for physical measures, and 21.2-67.6 for mental). Higher T-scores represent higher levels of global health. Scores are calibrated against the general population.
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)
Time Frame: Baseline and 10 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) are patient reported outcome surveys developed by the National Institutes for Health. This test is a computer adaptive test. Scores are represented as standardized T-scores relative to a population mean of 50 and SD of 10, with a minimum of 15.4 and maximum of 73.3. Higher T-scores represent higher levels of physical function. Scores are calibrated against the general population.
Baseline and 10 weeks
Clinical Measure 9: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System fatigue (v1.0)
Time Frame: Baseline and 10 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) are patient reported outcome surveys developed by the National Institutes for Health. This test is a computer adaptive test. Scores are represented as standardized T-scores relative to a population mean of 50 and SD of 10, with a minimum of 34.4 and maximum of 84.7. Higher T-scores represent higher levels of fatigue. Scores are calibrated against the general population.
Baseline and 10 weeks
Clinical Measure 10: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System anxiety (v1.0)
Time Frame: Baseline and 10 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) are patient reported outcome surveys developed by the National Institutes for Health. This test is a computer adaptive test. Raw scores are converted to standardized T-scores relative to a population mean of 50 and SD of 10 (minimum T-score is 32.9, maximum is 84.9). Higher T-scores represent higher levels of anxiety. Scores are calibrated against the general population.
Baseline and 10 weeks
Clinical Measure 11: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System depression (v1.0)
Time Frame: Baseline and 10 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) are patient reported outcome surveys developed by the National Institutes for Health. This test is a computer adaptive test. Scores are represented as standardized T-scores relative to a population mean of 50 and SD of 10 (minimum T-score is 34.2, maximum is 84.4). Higher T-scores represent higher levels of depression. Scores are calibrated against the general population.
Baseline and 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Natural Medicine

Investigators

  • Principal Investigator: Angela Senders, ND, MCR, Research Investigator and Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

March 16, 2018

Study Completion (Actual)

March 16, 2018

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

October 12, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 12, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102015 (Other Identifier: GSK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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