Qigong for Multiple Sclerosis: A Feasibility Study

Multiple Sclerosis Clinical Trial

Official title:

Qigong for Multiple Sclerosis: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04585659
• Other study ID #: 102015
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: March 16, 2018

Study information

• Verified date: September 2020
• Source: National University of Natural Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 16, 2018
• Est. primary completion date: March 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	National University of Natural Medicine, Helfgott Research Institute	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
National University of Natural Medicine

Country where clinical trial is conducted

United States, 

References & Publications (40)

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. — View Citation

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. Review. — View Citation

Beckerman 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. — View Citation

Ben-Zacharia AB. Therapeutics for multiple sclerosis symptoms. Mt Sinai J Med. 2011 Mar-Apr;78(2):176-91. doi: 10.1002/msj.20245. Review. — View Citation

Carter 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. — View Citation

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. — View Citation

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. — View Citation

Dite 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. — View Citation

Ensari 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. — View Citation

Fischer 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. d — View Citation

Fisk 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. — View Citation

González López-Arza MV, Varela-Donoso E, Montanero-Fernández J, Rodríguez-Mansilla J, González-Sánchez B, González López-Arza L. Qigong improves balance in young women: a pilot study. J Integr Med. 2013 Jul;11(4):241-5. doi: 10.3736/jintegrmed2013038. — View Citation

Guo 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. — View Citation

Haak T, Scott B. The effect of Qigong on fibromyalgia (FMS): a controlled randomized study. Disabil Rehabil. 2008;30(8):625-33. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Latimer-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. Review. — View Citation

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. — View Citation

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. — View Citation

Linke 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. Review. — View Citation

Marck 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. — View Citation

Mayo 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. — View Citation

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. — View Citation

Motl 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 — View Citation

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. Review. — View Citation

Nilsagård 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: 10.1177/13 — View Citation

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. — View Citation

Paul 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. Review. — View Citation

Peterson 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. — View Citation

Pilutti 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. — View Citation

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. — View Citation

Sawynok 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. — View Citation

Schmitz-Hübsch T, Pyfer D, Kielwein K, Fimmers R, Klockgether T, Wüllner U. Qigong exercise for the symptoms of Parkinson's disease: a randomized, controlled pilot study. Mov Disord. 2006 Apr;21(4):543-8. — View Citation

Senders 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. — View Citation

Taylor 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. Review. — View Citation

Warner L, McNeill ME. Mental imagery and its potential for physical therapy. Phys Ther. 1988 Apr;68(4):516-21. Review. — View Citation

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. — View Citation

Wu 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. — View Citation

Yost 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. — View Citation

* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Feasibility Outcome 2: Number of participants retained in the study	Goal to retain 80 percent of participants in the trial.	10 weeks
Primary	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
Primary	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	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.	Baseline and 10 weeks
Secondary	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.	Baseline and 10 weeks
Secondary	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.	Baseline and 10 weeks
Secondary	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.	Baseline and 10 weeks
Secondary	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).	Baseline and 10 weeks
Secondary	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.	Baseline and 10 weeks
Secondary	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.	Baseline and 10 weeks
Secondary	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.	Baseline and 10 weeks
Secondary	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.	Baseline and 10 weeks
Secondary	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.	Baseline and 10 weeks
Secondary	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.	Baseline and 10 weeks

External Links

•   Definition of Multiple Sclerosis
•   Provides information on MS including definition, treatment, prognosis, clinical trials