Clinical trial NCT04106661: Tai Chi as Physical Activity for Women With Morbid Obesity
Official title: Tai Chi Via DVD Instruction as an Introduction to Physical Activity for Women With Morbid Obesity: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Tai Chi
physical activity
morbid obesity
Lead sponsor: Husson University
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 17
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pretest-posttest control group design: The groups were determined by convenience sample due to the time-sensitive need to form the exercise groups. There were two arms of the study that aligned with two concurrent academic years. The first six participants to express interest were placed in the first Tai Chi intervention group. The next three participants were in the first control group. The second arm of the study had five participants who made contact before the second exercise group began. The second control group had three participants.
Primary purpose: TREATMENT

Brief summary: This study investigated the use of Tai Chi as a feasible form of physical activity for women with morbid obesity utilizing an instructional digital video disc (DVD). Two groups of women with morbid obesity (body mass index of \>40) were placed into the Tai Chi intervention group or the control group. Initial function was assessed with a series of tests and then repeated after 8 weeks. During the 8 weeks, the Tai Chi intervention group met once a week for 45 minutes to participate in a group exercise class. The control group was asked to continue their regular activity. At the end of the 8 weeks, both groups were reassessed with the same tests from the start of the study. The investigators hypothesized that the Tai Chi group would show more improvement in their functional scores for strength, balance and quality of life than the control group.

Detailed description: The purpose of this study was to investigate an alternative approach to physical activity in people who are morbidly obese to improve their overall health, functional mobility, and quality of life. Although physical activity is recommended in most weight management programs, the type of physical activity that results in the most successful outcomes has not been determined. Walking programs are among the most common forms recommended, however few parameters or guidelines are provided, and well-controlled comparisons to other types of exercise are lacking. Compliance with exercise programs is also a factor that impacts success, therefore offering solutions that improve compliance would be beneficial as well. This study investigated the use of home-based exercise enhanced with DVDs along with weekly, supervised group sessions to compare Tai Chi to a walking program in participants who are morbidly obese.

The participants were recruited from the community with the requirement that they have a body mass index of \>40 and have a diagnosis of morbid obesity. A falls risk screening, the Four Square Step Test (FSST), was performed on which they must score as a low fall risk. A battery of physical and paper tests will be completed prior to starting the study to assess balance, endurance, functional lower extremity strength, and quality of life. Both groups completed a self-report of their weekly physical activity that was submitted on an Activity Log. Those who were designated to be in the control group did not have any additional interaction with the study until week 10 when they returned for post-testing. The Tai Chi intervention group met one time per week as a group to practice Tai Chi with the DVD as the guide. Physical therapy students and faculty were present at each session to modify and supervise as needed. The intervention group also followed the DVD in the home setting for 2 additional sessions each week. Following the 8 weeks of structured classes and home activity, the participants returned the following week for the post-testing session.

Eligibility criteria: Inclusion Criteria:

* Body mass index greater than 40
* Completion of the four square step test in less than 15 seconds.

Exclusion Criteria:

* History of neurological insult or disease
* Cardiac condition limiting exercise
* Joint pain severely limiting movement
* Major surgery within 6 months

Primary outcomes:
measure: Four Square Step Test
timeFrame: 10 weeks
measure: Zeno Walkway Analysis of Gait Speed
timeFrame: 10 weeks
measure: 36-item Short Form Health Survey (SF-36)
timeFrame: 10 weeks
measure: Six Minute Walk Test (6MWT)
timeFrame: 10 weeks
measure: 30 Second Sit to Stand
timeFrame: 10 weeks
measure: Timed up and go Test
timeFrame: 10 weeks
measure: Single Leg Stance Test
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Husson University
name: Cathy Stucker, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA. 2012 Feb 1;307(5):491-7. doi: 10.1001/jama.2012.39. Epub 2012 Jan 17.
citation: Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
citation: Kahn EB, Ramsey LT, Brownson RC, Heath GW, Howze EH, Powell KE, Stone EJ, Rajab MW, Corso P. The effectiveness of interventions to increase physical activity. A systematic review. Am J Prev Med. 2002 May;22(4 Suppl):73-107. doi: 10.1016/s0749-3797(02)00434-8.
citation: Puhl R, Suh Y. Health Consequences of Weight Stigma: Implications for Obesity Prevention and Treatment. Curr Obes Rep. 2015 Jun;4(2):182-90. doi: 10.1007/s13679-015-0153-z.
citation: Liu X, Vitetta L, Kostner K, Crompton D, Williams G, Brown WJ, Lopez A, Xue CC, Oei TP, Byrne G, Martin JH, Whiteford H. The effects of tai chi in centrally obese adults with depression symptoms. Evid Based Complement Alternat Med. 2015;2015:879712. doi: 10.1155/2015/879712. Epub 2015 Jan 21.
citation: Lachman S, Boekholdt SM, Luben RN, Sharp SJ, Brage S, Khaw KT, Peters RJ, Wareham NJ. Impact of physical activity on the risk of cardiovascular disease in middle-aged and older adults: EPIC Norfolk prospective population study. Eur J Prev Cardiol. 2018 Jan;25(2):200-208. doi: 10.1177/2047487317737628. Epub 2017 Nov 21.
citation: Jagielski AC, Brown A, Hosseini-Araghi M, Thomas GN, Taheri S. The association between adiposity, mental well-being, and quality of life in extreme obesity. PLoS One. 2014 Mar 26;9(3):e92859. doi: 10.1371/journal.pone.0092859. eCollection 2014.
citation: Fjeldstad C, Fjeldstad AS, Acree LS, Nickel KJ, Gardner AW. The influence of obesity on falls and quality of life. Dyn Med. 2008 Feb 27;7:4. doi: 10.1186/1476-5918-7-4.
citation: Mitchell RJ, Lord SR, Harvey LA, Close JC. Associations between obesity and overweight and fall risk, health status and quality of life in older people. Aust N Z J Public Health. 2014 Feb;38(1):13-8. doi: 10.1111/1753-6405.12152.
citation: de Souza SA, Faintuch J, Valezi AC, Sant' Anna AF, Gama-Rodrigues JJ, de Batista Fonseca IC, Souza RB, Senhorini RC. Gait cinematic analysis in morbidly obese patients. Obes Surg. 2005 Oct;15(9):1238-42. doi: 10.1381/096089205774512627.
citation: Yeh SH, Chuang H, Lin LW, Hsiao CY, Eng HL. Regular tai chi chuan exercise enhances functional mobility and CD4CD25 regulatory T cells. Br J Sports Med. 2006 Mar;40(3):239-43. doi: 10.1136/bjsm.2005.022095.
citation: Audette JF, Jin YS, Newcomer R, Stein L, Duncan G, Frontera WR. Tai Chi versus brisk walking in elderly women. Age Ageing. 2006 Jul;35(4):388-93. doi: 10.1093/ageing/afl006. Epub 2006 Apr 19.
citation: Yildirim P, Ofluoglu D, Aydogan S, Akyuz G. Tai Chi vs. combined exercise prescription: A comparison of their effects on factors related to falls. J Back Musculoskelet Rehabil. 2016 Aug 10;29(3):493-501. doi: 10.3233/BMR-150645.
citation: Xiang Y, Lu L, Chen X, Wen Z. Does Tai Chi relieve fatigue? A systematic review and meta-analysis of randomized controlled trials. PLoS One. 2017 Apr 5;12(4):e0174872. doi: 10.1371/journal.pone.0174872. eCollection 2017.
citation: Xu F, Letendre J, Bekke J, Beebe N, Mahler L, Lofgren IE, Delmonico MJ. Impact of a program of Tai Chi plus behaviorally based dietary weight loss on physical functioning and coronary heart disease risk factors: a community-based study in obese older women. J Nutr Gerontol Geriatr. 2015;34(1):50-65. doi: 10.1080/21551197.2014.1003672.
citation: Thornton EW, Sykes KS, Tang WK. Health benefits of Tai Chi exercise: improved balance and blood pressure in middle-aged women. Health Promot Int. 2004 Mar;19(1):33-8. doi: 10.1093/heapro/dah105.
citation: Dechamps A, Gatta B, Bourdel-Marchasson I, Tabarin A, Roger P. Pilot study of a 10-week multidisciplinary Tai Chi intervention in sedentary obese women. Clin J Sport Med. 2009 Jan;19(1):49-53. doi: 10.1097/JSM.0b013e318193428f.
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. doi: 10.1053/apmr.2002.35469.
citation: Topolski TD, LoGerfo J, Patrick DL, Williams B, Walwick J, Patrick MB. The Rapid Assessment of Physical Activity (RAPA) among older adults. Prev Chronic Dis. 2006 Oct;3(4):A118. Epub 2006 Sep 15.
citation: Bennell K, Dobson F, Hinman R. Measures of physical performance assessments: Self-Paced Walk Test (SPWT), Stair Climb Test (SCT), Six-Minute Walk Test (6MWT), Chair Stand Test (CST), Timed Up & Go (TUG), Sock Test, Lift and Carry Test (LCT), and Car Task. Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S350-70. doi: 10.1002/acr.20538. No abstract available.
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. doi: 10.1111/j.1532-5415.1991.tb01616.x.
citation: Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.
citation: Lin MR, Hwang HF, Hu MH, Wu HD, Wang YW, Huang FC. Psychometric comparisons of the timed up and go, one-leg stand, functional reach, and Tinetti balance measures in community-dwelling older people. J Am Geriatr Soc. 2004 Aug;52(8):1343-8. doi: 10.1111/j.1532-5415.2004.52366.x.
citation: Springer BA, Marin R, Cyhan T, Roberts H, Gill NW. Normative values for the unipedal stance test with eyes open and closed. J Geriatr Phys Ther. 2007;30(1):8-15. doi: 10.1519/00139143-200704000-00003.
citation: Li F, Harmer P, McAuley E, Fisher KJ, Duncan TE, Duncan SC. Tai Chi, self-efficacy, and physical function in the elderly. Prev Sci. 2001 Dec;2(4):229-39. doi: 10.1023/a:1013614200329.