NCT04106661

Tai Chi as Physical Activity for Women With Morbid Obesity

Completed NA Results posted Last updated 9 October 2024

What this trial tests

NA trial testing Tai Chi in Morbid Obesity in 17 participants. Completed in 21 November 2017.

Timeline

2 September 2016

Primary endpoint
21 November 2017

21 November 2017

Quick facts

Lead sponsor	Husson University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	17
Start date	2 September 2016
Primary completion	21 November 2017
Estimated completion	21 November 2017

Drugs / interventions tested

• Tai Chi

Conditions studied

• Morbid Obesity — all drugs for Morbid Obesity →

Sponsor

Husson University

Who can join

21 and older, female only, with Morbid Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Four Square Step Test Primary · 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

Pre-test

Group	Value	95% CI
Tai Chi Intervention 1	9.91	± 2.02
Tai Chi Intervention 2	10.17	± 2.82

Post-test

Group	Value	95% CI
Tai Chi Intervention 1	8.93	± 2.04
Tai Chi Intervention 2	9.50	± 1.74

Zeno Walkway Analysis of Gait Speed Primary · 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.

Gait Speed Pre Test

Group	Value	95% CI
Tai Chi Intervention	1.20	± .14
Control Group	1.07	± .23

Gait Speed Post Test

Group	Value	95% CI
Tai Chi Intervention	1.27	± .14
Control Group	1.17	± .21

36-item Short Form Health Survey (SF-36) Primary · 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.

Overall Score, Pre Test

Group	Value	95% CI
Tai Chi Intervention	586.0	139 – 663
Control Group	564.0	221.5 – 615

Overall Score, Post Test

Group	Value	95% CI
Tai Chi Intervention	598.5	289 – 680
Control Group	533.0	247.3 – 644

Six Minute Walk Test (6MWT) Primary · 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.

Pre-test

Group	Value	95% CI
Tai Chi Intervention 1	126.84	± 29.17
Tai Chi Intervention 2	110.70	± 26.45

Post-test

Group	Value	95% CI
Tai Chi Intervention 1	131.58	± 30.81
Tai Chi Intervention 2	116.52	± 25.01

30 Second Sit to Stand Primary · 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.

Pre-test

Group	Value	95% CI
Tai Chi Intervention 1	13.14	± 2.12
Tai Chi Intervention 2	13.80	± 3.84

Post-test

Group	Value	95% CI
Tai Chi Intervention 1	13.29	± 1.50
Tai Chi Intervention 2	14.60	± 2.70

Timed up and go Test Primary · 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.

Pre-test

Group	Value	95% CI
Tai Chi Intervention 1	8.62	± 1.27
Tai Chi Intervention 2	10.08	± 1.67

Post-test

Group	Value	95% CI
Tai Chi Intervention 1	8.07	± 1.51
Tai Chi Intervention 2	9.46	± 2.91

Single Leg Stance Test Primary · 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 3

Eyes Closed, Right Pre-test

Group	Value	95% CI
Tai Chi Intervention 1	1.95	± 2.23
Tai Chi Intervention 2	3.29	± 2.23

Eyes Closed, Right Post-test

Group	Value	95% CI
Tai Chi Intervention 1	2.22	± 2.32
Tai Chi Intervention 2	3.62	± 1.60

Eyes Closed, Left Pre-test

Group	Value	95% CI
Tai Chi Intervention 1	3.71	± 2.29
Tai Chi Intervention 2	5.27	± 4.70

Eyes Closed, Left Post-test

Group	Value	95% CI
Tai Chi Intervention 1	8.35	± 10.56
Tai Chi Intervention 2	3.53	± 2.17

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.