Qigong for Multiple Sclerosis: A Feasibility Study
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable multiple-sclerosis
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2018
CompletedFirst Submitted
Initial submission to the registry
September 2, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedOctober 14, 2020
September 1, 2020
1.1 years
September 2, 2020
October 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Feasibility Outcome 1: Number of participants recruited for the study
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
Goal to retain 80 percent of participants in the trial.
10 weeks
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.
10 weeks
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.
10 weeks
Secondary Outcomes (11)
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 3: Multidirectional mobility assessed by the Four-Square-Step-Test
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 5: Impact of multiple sclerosis on walking ability assessed by the Multiple Sclerosis Walking Scale (MSWS-12)
Baseline and 10 weeks
- +6 more secondary outcomes
Study Arms (2)
Qigong Intervention
EXPERIMENTAL60-90 minute community qigong classes, once per week plus at least 10 minutes of home practice
Wait-List Control
NO 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.
Interventions
Mind-body movement art that includes specific movements, breath exercises, stretching and meditation.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National University of Natural Medicine, Helfgott Research Institute
Portland, Oregon, 97201, United States
Related Publications (42)
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.
PMID: 22316445BACKGROUNDAmano 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.
PMID: 23835431BACKGROUNDSchmitz-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.
PMID: 16229022BACKGROUNDWayne 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.
PMID: 20193083BACKGROUNDD'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.
PMID: 27016749BACKGROUNDHobart 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.
PMID: 12525714BACKGROUNDHobart 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.
PMID: 11335698BACKGROUNDPodsiadlo 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.
PMID: 1991946BACKGROUNDLearmonth 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.
PMID: 23587605BACKGROUNDChan 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.
PMID: 23983785BACKGROUNDNi 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.
PMID: 24927169BACKGROUNDHo 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.
PMID: 22736201BACKGROUNDOh 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.
PMID: 19880433BACKGROUNDMills 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.
PMID: 11072058BACKGROUNDAsano 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.
PMID: 24963407BACKGROUNDBeckerman H, Blikman LJ, Heine M, Malekzadeh A, Teunissen CE, Bussmann JB, Kwakkel G, van Meeteren J, de Groot V; TREFAMS-ACE study group. The effectiveness of aerobic training, cognitive behavioural therapy, and energy conservation management in treating MS-related fatigue: the design of the TREFAMS-ACE programme. Trials. 2013 Aug 12;14:250. doi: 10.1186/1745-6215-14-250.
PMID: 23938046BACKGROUNDCarter AM, Daley AJ, Kesterton SW, Woodroofe NM, Saxton JM, Sharrack B. Pragmatic exercise intervention in people with mild to moderate multiple sclerosis: a randomised controlled feasibility study. Contemp Clin Trials. 2013 Jul;35(2):40-7. doi: 10.1016/j.cct.2013.04.003. Epub 2013 Apr 21.
PMID: 23612222BACKGROUNDEnsari I, Motl RW, Pilutti LA. Exercise training improves depressive symptoms in people with multiple sclerosis: results of a meta-analysis. J Psychosom Res. 2014 Jun;76(6):465-71. doi: 10.1016/j.jpsychores.2014.03.014. Epub 2014 Mar 31.
PMID: 24840141BACKGROUNDLatimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta AM, MacKibbon KA, Motl RW. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3. doi: 10.1016/j.apmr.2013.04.020. Epub 2013 May 10.
PMID: 23669008BACKGROUNDMarck CH, Hadgkiss EJ, Weiland TJ, van der Meer DM, Pereira NG, Jelinek GA. Physical activity and associated levels of disability and quality of life in people with multiple sclerosis: a large international survey. BMC Neurol. 2014 Jul 12;14:143. doi: 10.1186/1471-2377-14-143.
PMID: 25016312BACKGROUNDMayo NE, Bayley M, Duquette P, Lapierre Y, Anderson R, Bartlett S. The role of exercise in modifying outcomes for people with multiple sclerosis: a randomized trial. BMC Neurol. 2013 Jun 28;13:69. doi: 10.1186/1471-2377-13-69.
PMID: 23809312BACKGROUNDPilutti LA, Dlugonski D, Sandroff BM, Klaren R, Motl RW. Randomized controlled trial of a behavioral intervention targeting symptoms and physical activity in multiple sclerosis. Mult Scler. 2014 Apr;20(5):594-601. doi: 10.1177/1352458513503391. Epub 2013 Sep 5.
PMID: 24009162BACKGROUNDGuo LY, Yang CP, You YL, Chen SK, Yang CH, Hou YY, Wu WL. Underlying mechanisms of Tai-Chi-Chuan training for improving balance ability in the elders. Chin J Integr Med. 2014 Jun;20(6):409-15. doi: 10.1007/s11655-013-1533-4. Epub 2014 Jun 21.
PMID: 24952168BACKGROUNDGonzalez Lopez-Arza MV, Varela-Donoso E, Montanero-Fernandez J, Rodriguez-Mansilla J, Gonzalez-Sanchez B, Gonzalez Lopez-Arza L. Qigong improves balance in young women: a pilot study. J Integr Med. 2013 Jul;11(4):241-5. doi: 10.3736/jintegrmed2013038.
PMID: 23867242BACKGROUNDWu CY, Han HM, Huang MC, Chen YM, Yu WP, Weng LC. Effect of qigong training on fatigue in haemodialysis patients: A non-randomized controlled trial. Complement Ther Med. 2014 Apr;22(2):244-50. doi: 10.1016/j.ctim.2014.01.004. Epub 2014 Jan 10.
PMID: 24731895BACKGROUNDSawynok J, Lynch M, Marcon D. Extension trial of qigong for fibromyalgia: a quantitative and qualitative study. Evid Based Complement Alternat Med. 2013;2013:726062. doi: 10.1155/2013/726062. Epub 2013 Aug 28.
PMID: 24069054BACKGROUNDHaak T, Scott B. The effect of Qigong on fibromyalgia (FMS): a controlled randomized study. Disabil Rehabil. 2008;30(8):625-33. doi: 10.1080/09638280701400540.
PMID: 17852292BACKGROUNDWarner L, McNeill ME. Mental imagery and its potential for physical therapy. Phys Ther. 1988 Apr;68(4):516-21. doi: 10.1093/ptj/68.4.516.
PMID: 3281175BACKGROUNDPaul L, Coote S, Crosbie J, Dixon D, Hale L, Holloway E, McCrone P, Miller L, Saxton J, Sincock C, White L. Core outcome measures for exercise studies in people with multiple sclerosis: recommendations from a multidisciplinary consensus meeting. Mult Scler. 2014 Oct;20(12):1641-50. doi: 10.1177/1352458514526944. Epub 2014 Mar 17.
PMID: 24639480BACKGROUNDSenders A, Hanes D, Bourdette D, Whitham R, Shinto L. Reducing survey burden: feasibility and validity of PROMIS measures in multiple sclerosis. Mult Scler. 2014 Jul;20(8):1102-11. doi: 10.1177/1352458513517279. Epub 2014 Jan 8.
PMID: 24402035BACKGROUNDFisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis. 1994 Jan;18 Suppl 1:S79-83. doi: 10.1093/clinids/18.supplement_1.s79.
PMID: 8148458BACKGROUNDDite W, Temple VA. A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002 Nov;83(11):1566-71. doi: 10.1053/apmr.2002.35469.
PMID: 12422327BACKGROUNDLinke SE, Gallo LC, Norman GJ. Attrition and adherence rates of sustained vs. intermittent exercise interventions. Ann Behav Med. 2011 Oct;42(2):197-209. doi: 10.1007/s12160-011-9279-8.
PMID: 21604068BACKGROUNDYost KJ, Eton DT, Garcia SF, Cella D. Minimally important differences were estimated for six Patient-Reported Outcomes Measurement Information System-Cancer scales in advanced-stage cancer patients. J Clin Epidemiol. 2011 May;64(5):507-16. doi: 10.1016/j.jclinepi.2010.11.018.
PMID: 21447427BACKGROUNDBen-Zacharia AB. Therapeutics for multiple sclerosis symptoms. Mt Sinai J Med. 2011 Mar-Apr;78(2):176-91. doi: 10.1002/msj.20245.
PMID: 21425263RESULTNilsagard 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.
PMID: 24948687RESULTPeterson EW, Cho CC, von Koch L, Finlayson ML. Injurious falls among middle aged and older adults with multiple sclerosis. Arch Phys Med Rehabil. 2008 Jun;89(6):1031-7. doi: 10.1016/j.apmr.2007.10.043.
PMID: 18503796RESULTFischer 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.
PMID: 24845395RESULTMotl 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.
PMID: 28206828RESULTTaylor 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.
PMID: 28434462RESULTButtolph 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.
PMID: 36895618DERIVEDButtolph 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.
PMID: 33769837DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angela Senders, ND, MCR
Research Investigator and Assistant Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2020
First Posted
October 14, 2020
Study Start
February 1, 2017
Primary Completion
March 16, 2018
Study Completion
March 16, 2018
Last Updated
October 14, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share