Morbid ObesityNCT04106661
Tai Chi as Physical Activity for Women With Morbid Obesity
A study testing Tai Chi in people with Morbid Obesity, run by Husson University.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Tai Chi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2016to 21 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index greater than 40
- Completion of the four square step test in less than 15 seconds.
Who cannot join
- History of neurological insult or disease
- Cardiac condition limiting exercise
- Joint pain severely limiting movement
- Major surgery within 6 months
About this study
Official title: Tai Chi Via DVD Instruction as an Introduction to Physical Activity for Women With Morbid Obesity: a Feasibility Study
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.
Read the 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.
- Conditions
- Morbid Obesity
- Being tested
- Tai Chi
- Keywords
- Tai Chi, physical activity, morbid obesity
- Medical subject headings
- Obesity, Morbid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiOther
Also called physical activity
Physical activity requiring slow, controlled whole body movement and weight shifting.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi Intervention 1 | Experimental | The intervention group and control group were recruited during the same time frame. The intervention group received Tai Chi instruction via a weekly group session and home use of a DVD. The control group received no formal instruction in physical activity. Receives: Other: Tai Chi |
| Tai Chi Intervention 2 | Experimental | The intervention group and control group were recruited during the same time frame. The intervention group received Tai Chi instruction via a weekly group session and home use of a DVD. The control group received no formal instruction in physical activity. Receives: Other: Tai Chi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Four Square Step Test
Three-quarter inch diameter plastic tubing was placed on the ground to form a plus sign. The participant was required to step as fast as possible starting in square 1 in a clockwise direction and then returning counterclockwise making full contact in each square with both feet and not touching the tubing. The participants were required to complete the Four Square Step Test in 15 seconds or less in order to be included in the study based on the research that a time longer than 15 seconds is predictive of multiple falls. The results were compared at the conclusion of the study as an indicator of balance.
Measured: 10 weeks
Zeno Walkway Analysis of Gait Speed
Participants were asked to walk along the gait mat for a total of four passes. A piece of tape was placed one meter before and after the gait mat. Participants were instructed to turn around once they reached the piece of tape to decrease the effects of acceleration and deceleration on the gait mat. Data collected on the Protokinetics Zeno Walkway included the participants' gait speed.
Measured: 10 weeks
36-item Short Form Health Survey (SF-36)
The SF-36 was used to measure how each participant viewed their physical and mental health. The questionnaire contained sections that covered vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Overall, the SF-36 has the ability to measure the well-being of older adults . Scores on the SF-36 range from 0-700, with a lower score identifying greater disability and a higher score suggesting less disability.
Measured: 10 weeks
Six Minute Walk Test (6MWT)
The 6MWT is a submaximal test of endurance measuring total distance walked in six minutes. A 100 foot walking path was measured down a level, hard surfaced hallway. The participant was asked to repeatedly walk the complete length of the 100 foot walking path as many times as possible in six minutes at a comfortable pace. The participant was allowed to rest during this test, however, the timer did not stop until the six minute time frame had been completed. The total distance upon completion of the 6MWT was documented.
Measured: 10 weeks
30 Second Sit to Stand
The 30 Second Sit to Stand is a test of lower extremity functional strength. This test consists of rising from a standard height chair and returning to sitting as many times as the person is able to within 30 seconds without the use of their upper extremities. It is a measure of lower extremity functional strength.
Measured: 10 weeks
Timed up and go Test
The Timed Up and Go test (TUG) begins with the participant seated in an armchair. The participant is instructed to stand up and walk at a comfortable pace to a mark three meters in front of the chair, turn around, walk back to the chair, and sit down. The test is timed, and participants are allowed to use the arms of the chair and an assistive device if they choose. This assessment correlates with fall risk and functional mobility.
Measured: 10 weeks
Single Leg Stance Test
The Single Leg Stance test (SLS) test measures static balance while standing on one leg, with a longer time indicating better balance ability. A participant would stand on one leg and hold the position as long as they could up to 30 seconds. Participants were required to perform 3 trials with eyes open and 3 trials with eyes closed on both limbs. The longest of the three trials was used for data analysis. The timer was stopped in the following situations: (1) the foot of the non-stance leg touched the floor, (2) the lower extremities made contact with each other, (3) the participant exceeded 30 seconds of single leg stance, or (4) the participant opened their eyes on the eyes closed trial.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start2 Sep 2016
- Primary completion21 Nov 2017
- Study completion21 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Husson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathy Stucker, Husson University
- Investigators
- Cathy Stucker, DSc, Principal investigator, Husson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106661
- Sponsor's protocol ID
- 16PT03
- Other IDs
- 16-1-M-325
- Status last verified
- Oct 2024
- First submitted
- 25 Sep 2019
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22253363Ogden 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.
PubMed 24570244Kahn 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.
PubMed 11985936Puhl 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.
PubMed 26627213Liu 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.
PubMed 25688280Lachman 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.
PubMed 29161890Jagielski 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.
PubMed 24671197Fjeldstad 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.
PubMed 18304350Mitchell 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.
PubMed 24494939de 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.
PubMed 16259878Yeh 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.
PubMed 16505081Audette 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.
PubMed 16624847Yildirim 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.
PubMed 26519119Xiang 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.
PubMed 28380067Xu 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.
PubMed 25803604
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi Via DVD Instruction as an Introduction to Physical Activity for Women With Morbid Obesity: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04106661
- Acronym / sponsor ID
- 16PT03
- Conditions
- Morbid Obesity
- Keywords
- Tai Chi, physical activity, morbid obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Husson UniversityUniversity, hospital or other
- Study start
- 2 Sep 2016 (actual)
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 21 Nov 2017 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Posted 9 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tai Chi Intervention 1 | Experimental | Other: Tai ChiThe intervention group and control group were recruited during the same time frame. The intervention group received Tai Chi instruction via a weekly group session and home use of a DVD. The control group received no formal instruction in physical activity. |
| Tai Chi Intervention 2 | Experimental | Other: Tai ChiThe intervention group and control group were recruited during the same time frame. The intervention group received Tai Chi instruction via a weekly group session and home use of a DVD. The control group received no formal instruction in physical activity. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index greater than 40
- Completion of the four square step test in less than 15 seconds.
Key exclusion criteria (4 listed)
- History of neurological insult or disease
- Cardiac condition limiting exercise
- Joint pain severely limiting movement
- Major surgery within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai ChiAlso: physical activityPhysical activity requiring slow, controlled whole body movement and weight shifting. | Other | Tai Chi Intervention 1, Tai Chi Intervention 2 |
Primary outcome
Four Square Step Test
Time frame: 10 weeks
Three-quarter inch diameter plastic tubing was placed on the ground to form a plus sign. The participant was required to step as fast as possible starting in square 1 in a clockwise direction and then returning counterclockwise making full contact in each square with both feet and not touching the tubing. The participants were required to complete the Four Square Step Test in 15 seconds or less in order to be included in the study based on the research that a time longer than 15 seconds is predictive of multiple falls. The results were compared at the conclusion of the study as an indicator of balance.
Zeno Walkway Analysis of Gait Speed
Time frame: 10 weeks
Participants were asked to walk along the gait mat for a total of four passes. A piece of tape was placed one meter before and after the gait mat. Participants were instructed to turn around once they reached the piece of tape to decrease the effects of acceleration and deceleration on the gait mat. Data collected on the Protokinetics Zeno Walkway included the participants' gait speed.
36-item Short Form Health Survey (SF-36)
Time frame: 10 weeks
The SF-36 was used to measure how each participant viewed their physical and mental health. The questionnaire contained sections that covered vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Overall, the SF-36 has the ability to measure the well-being of older adults . Scores on the SF-36 range from 0-700, with a lower score identifying greater disability and a higher score suggesting less disability.
Six Minute Walk Test (6MWT)
Time frame: 10 weeks
The 6MWT is a submaximal test of endurance measuring total distance walked in six minutes. A 100 foot walking path was measured down a level, hard surfaced hallway. The participant was asked to repeatedly walk the complete length of the 100 foot walking path as many times as possible in six minutes at a comfortable pace. The participant was allowed to rest during this test, however, the timer did not stop until the six minute time frame had been completed. The total distance upon completion of the 6MWT was documented.
30 Second Sit to Stand
Time frame: 10 weeks
The 30 Second Sit to Stand is a test of lower extremity functional strength. This test consists of rising from a standard height chair and returning to sitting as many times as the person is able to within 30 seconds without the use of their upper extremities. It is a measure of lower extremity functional strength.
Timed up and go Test
Time frame: 10 weeks
The Timed Up and Go test (TUG) begins with the participant seated in an armchair. The participant is instructed to stand up and walk at a comfortable pace to a mark three meters in front of the chair, turn around, walk back to the chair, and sit down. The test is timed, and participants are allowed to use the arms of the chair and an assistive device if they choose. This assessment correlates with fall risk and functional mobility.
Single Leg Stance Test
Time frame: 10 weeks
The Single Leg Stance test (SLS) test measures static balance while standing on one leg, with a longer time indicating better balance ability. A participant would stand on one leg and hold the position as long as they could up to 30 seconds. Participants were required to perform 3 trials with eyes open and 3 trials with eyes closed on both limbs. The longest of the three trials was used for data analysis. The timer was stopped in the following situations: (1) the foot of the non-stance leg touched the floor, (2) the lower extremities made contact with each other, (3) the participant exceeded 30 seconds of single leg stance, or (4) the participant opened their eyes on the eyes closed trial.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22253363Flegal 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.
- Background: PubMed 24570244Ogden 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.
- Background: PubMed 11985936Kahn 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.
- Background: PubMed 26627213Puhl 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.
- Background: PubMed 25688280Liu 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.
- Background: PubMed 29161890Lachman 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.
- Background: PubMed 24671197Jagielski 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.
- Background: PubMed 18304350Fjeldstad 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.
- Background: PubMed 24494939Mitchell 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.
- Background: PubMed 16259878de 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.
- Background: PubMed 16505081Yeh 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.
- Background: PubMed 16624847Audette 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy Stucker, DSc principal investigator
Husson University
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi in people with Morbid Obesity, run by Husson University.
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 2 inclusion and 4 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 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Four Square Step Test (time frame: 10 weeks). The study lists 7 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 NCT04106661, which also lists 25 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 9 Oct 2024.