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Multiple SclerosisNCT04585659

Qigong for Multiple Sclerosis: A Feasibility Study

A study testing Qigong in people with Multiple Sclerosis, run by National University of Natural Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
Qigong
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Feb 2017to 16 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • National University of Natural Medicine, Helfgott Research Institute

    Portland, Oregon, 97201

Other trials in United States

About this study

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.

Read the 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.

Being tested
Qigong
Keywords
Qigong, Pragmatic Design, Gait, Multiple Sclerosis
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QigongOther

    Also called Qi-gong

    Mind-body movement art that includes specific movements, breath exercises, stretching and meditation.

Study groups in NCT04585659
Study groupRoleWhat they receive
Qigong InterventionExperimental60-90 minute community qigong classes, once per week plus at least 10 minutes of home practice
Receives: Other: Qigong
Wait-List ControlNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility Outcome 1: Number of participants recruited for the study

    Ability to recruit and enroll 20 participants with multiple sclerosis (MS) within 8 months.

    Measured: 8 months

  2. Feasibility Outcome 2: Number of participants retained in the study

    Goal to retain 80 percent of participants in the trial.

    Measured: 10 weeks

  3. Feasibility Outcome 3: Percent able to participate in qigong classes

    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.

    Measured: 10 weeks

  4. Feasibility Outcome 4: Percent attendance in qigong classes

    Class attendance measured by self-report in exit survey and tracked by qigong instructor, with the goal of 70 percent attendance in class.

    Measured: 10 weeks

Secondary outcomes (11)
  1. Clinical Measure 1: Walking speed assessed by the Timed-25-Foot-Walk Test

    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.

    Measured: Baseline and 10 weeks

  2. Clinical Measure 2: Mobility, balance and walking ability assessed by the Timed-Up-and-Go Test

    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.

    Measured: Baseline and 10 weeks

  3. Clinical Measure 3: Multidirectional mobility assessed by the Four-Square-Step-Test

    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.

    Measured: Baseline and 10 weeks

  4. Clinical Measure 4: Physical and psychological well-being assessed by the Multiple Sclerosis Impact Scale (MSIS-29)

    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.

    Measured: Baseline and 10 weeks

  5. Clinical Measure 5: Impact of multiple sclerosis on walking ability assessed by the Multiple Sclerosis Walking Scale (MSWS-12)

    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).

    Measured: Baseline and 10 weeks

  6. Clinical Measure 6: Fatigue assessed by the Modified Fatigue Impact Scale Short Version (MFIS-5)

    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.

    Measured: Baseline and 10 weeks

  7. Clinical Measure 7: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System global heath (mental and physical, v1.1)

    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.

    Measured: Baseline and 10 weeks

  8. Clinical Measure 8: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System physical function (v1.2)

    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.

    Measured: Baseline and 10 weeks

  9. Clinical Measure 9: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System fatigue (v1.0)

    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.

    Measured: Baseline and 10 weeks

  10. Clinical Measure 10: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System anxiety (v1.0)

    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.

    Measured: Baseline and 10 weeks

  11. Clinical Measure 11: Health-related quality of life assessed by the Patient Reported Outcomes Measurement Information System depression (v1.0)

    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.

    Measured: Baseline and 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start1 Feb 2017
  3. Primary completion16 Mar 2018
  4. Study completion16 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04585659
Sponsor's protocol ID
102015
Status last verified
Sep 2020
First submitted
2 Sep 2020
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li F, Harmer P, Fitzgerald K, Eckstrom E, Stock R, Galver J, Maddalozzo G, Batya SS. Tai chi and postural stability in patients with Parkinson's disease. N Engl J Med. 2012 Feb 9;366(6):511-9. doi: 10.1056/NEJMoa1107911.

    PubMed 22316445
  • Amano S, Nocera JR, Vallabhajosula S, Juncos JL, Gregor RJ, Waddell DE, Wolf SL, Hass CJ. The effect of Tai Chi exercise on gait initiation and gait performance in persons with Parkinson's disease. Parkinsonism Relat Disord. 2013 Nov;19(11):955-60. doi: 10.1016/j.parkreldis.2013.06.007. Epub 2013 Jul 5.

    PubMed 23835431
  • Schmitz-Hubsch T, Pyfer D, Kielwein K, Fimmers R, Klockgether T, Wullner U. Qigong exercise for the symptoms of Parkinson's disease: a randomized, controlled pilot study. Mov Disord. 2006 Apr;21(4):543-8. doi: 10.1002/mds.20705.

    PubMed 16229022
  • Wayne PM, Buring JE, Davis RB, Connors EM, Bonato P, Patritti B, Fischer M, Yeh GY, Cohen CJ, Carroll D, Kiel DP. Tai Chi for osteopenic women: design and rationale of a pragmatic randomized controlled trial. BMC Musculoskelet Disord. 2010 Mar 1;11:40. doi: 10.1186/1471-2474-11-40.

    PubMed 20193083
  • D'Souza E. Modified Fatigue Impact Scale - 5-item version (MFIS-5). Occup Med (Lond). 2016 Apr;66(3):256-7. doi: 10.1093/occmed/kqv106. No abstract available.

    PubMed 27016749
  • Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology. 2003 Jan 14;60(1):31-6. doi: 10.1212/wnl.60.1.31.

    PubMed 12525714
  • Hobart J, Lamping D, Fitzpatrick R, Riazi A, Thompson A. The Multiple Sclerosis Impact Scale (MSIS-29): a new patient-based outcome measure. Brain. 2001 May;124(Pt 5):962-73. doi: 10.1093/brain/124.5.962.

    PubMed 11335698
  • Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

    PubMed 1991946
  • Learmonth YC, Dlugonski DD, Pilutti LA, Sandroff BM, Motl RW. The reliability, precision and clinically meaningful change of walking assessments in multiple sclerosis. Mult Scler. 2013 Nov;19(13):1784-91. doi: 10.1177/1352458513483890. Epub 2013 Apr 15.

    PubMed 23587605
  • Chan JS, Ho RT, Wang CW, Yuen LP, Sham JS, Chan CL. Effects of qigong exercise on fatigue, anxiety, and depressive symptoms of patients with chronic fatigue syndrome-like illness: a randomized controlled trial. Evid Based Complement Alternat Med. 2013;2013:485341. doi: 10.1155/2013/485341. Epub 2013 Jul 31.

    PubMed 23983785
  • Ni X, Liu S, Lu F, Shi X, Guo X. Efficacy and safety of Tai Chi for Parkinson's disease: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2014 Jun 13;9(6):e99377. doi: 10.1371/journal.pone.0099377. eCollection 2014.

    PubMed 24927169
  • Ho RT, Chan JS, Wang CW, Lau BW, So KF, Yuen LP, Sham JS, Chan CL. A randomized controlled trial of qigong exercise on fatigue symptoms, functioning, and telomerase activity in persons with chronic fatigue or chronic fatigue syndrome. Ann Behav Med. 2012 Oct;44(2):160-70. doi: 10.1007/s12160-012-9381-6.

    PubMed 22736201
  • Oh B, Butow P, Mullan B, Clarke S, Beale P, Pavlakis N, Kothe E, Lam L, Rosenthal D. Impact of medical Qigong on quality of life, fatigue, mood and inflammation in cancer patients: a randomized controlled trial. Ann Oncol. 2010 Mar;21(3):608-614. doi: 10.1093/annonc/mdp479. Epub 2009 Oct 30.

    PubMed 19880433
  • Mills N, Allen J. Mindfulness of movement as a coping strategy in multiple sclerosis. A pilot study. Gen Hosp Psychiatry. 2000 Nov-Dec;22(6):425-31. doi: 10.1016/s0163-8343(00)00100-6.

    PubMed 11072058
  • Asano M, Finlayson ML. Meta-analysis of three different types of fatigue management interventions for people with multiple sclerosis: exercise, education, and medication. Mult Scler Int. 2014;2014:798285. doi: 10.1155/2014/798285. Epub 2014 May 14.

    PubMed 24963407

Questions about this trial

What is this clinical trial studying?

A study testing Qigong in people with Multiple Sclerosis, run by National University of Natural Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility Outcome 1: Number of participants recruited for the study (time frame: 8 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04585659, which also lists 42 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020; AzTrials last refreshed its copy on 28 Oct 2026.

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