Trial Outcomes & Findings for Tai Chi as Physical Activity for Women With Morbid Obesity (NCT NCT04106661)
NCT ID: NCT04106661
Last Updated: 2024-10-09
Results Overview
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.
COMPLETED
NA
17 participants
10 weeks
2024-10-09
Participant Flow
Participant milestones
| Measure |
Tai Chi Intervention
The intervention group received Tai Chi instruction via a weekly group session and home use of a DVD (digital versatile disc) for a period of 8 weeks.
|
Control Group
The control group received no formal instruction in physical activity.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
6
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Tai Chi Intervention
The intervention group received Tai Chi instruction via a weekly group session and home use of a DVD (digital versatile disc) for a period of 8 weeks.
|
Control Group
The control group received no formal instruction in physical activity.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Scheduling difficulties
|
1
|
1
|
Baseline Characteristics
Tai Chi as Physical Activity for Women With Morbid Obesity
Baseline characteristics by cohort
| Measure |
Tai Chi Intervention
n=7 Participants
The intervention group received Tai Chi instruction via a weekly group session and home use of a DVD for a period of 8 weeks.
|
Control Group
n=5 Participants
The control group received no formal instruction in physical activity.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 10.6 • n=99 Participants
|
51.8 years
STANDARD_DEVIATION 10.3 • n=107 Participants
|
51.7 years
STANDARD_DEVIATION 10.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
5 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Weight
|
278.36 pounds
STANDARD_DEVIATION 28.95 • n=99 Participants
|
266.72 pounds
STANDARD_DEVIATION 23.01 • n=107 Participants
|
273.51 pounds
STANDARD_DEVIATION 26.18 • n=206 Participants
|
|
BMI
|
45.93 kg/meters squared
STANDARD_DEVIATION 4.9 • n=99 Participants
|
50.04 kg/meters squared
STANDARD_DEVIATION 3.63 • n=107 Participants
|
47.64 kg/meters squared
STANDARD_DEVIATION 4.72 • n=206 Participants
|
|
Four Square Step Test
|
9.91 seconds
STANDARD_DEVIATION 2.02 • n=99 Participants
|
10.17 seconds
STANDARD_DEVIATION 2.82 • n=107 Participants
|
10.02 seconds
STANDARD_DEVIATION 2.27 • n=206 Participants
|
|
30 Second Sit to Stand
|
13.14 repetitions
STANDARD_DEVIATION 2.12 • n=99 Participants
|
13.80 repetitions
STANDARD_DEVIATION 3.83 • n=107 Participants
|
13.42 repetitions
STANDARD_DEVIATION 2.81 • n=206 Participants
|
|
Timed Up and Go
|
8.62 seconds
STANDARD_DEVIATION 1.27 • n=99 Participants
|
10.08 seconds
STANDARD_DEVIATION 1.67 • n=107 Participants
|
9.23 seconds
STANDARD_DEVIATION 1.57 • n=206 Participants
|
|
6 Minute Walk Test
|
416.14 feet
STANDARD_DEVIATION 95.69 • n=99 Participants
|
363.20 feet
STANDARD_DEVIATION 86.76 • n=107 Participants
|
394.08 feet
STANDARD_DEVIATION 92.06 • n=206 Participants
|
PRIMARY outcome
Timeframe: 10 weeksThree-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.
Outcome measures
| Measure |
Tai Chi Intervention 1
n=7 Participants
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.
Tai Chi: Physical activity requiring slow, controlled whole body movement and weight shifting.
|
Tai Chi Intervention 2
n=5 Participants
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.
Tai Chi: Physical activity requiring slow, controlled whole body movement and weight shifting.
|
|---|---|---|
|
Four Square Step Test
Pre-test
|
9.91 seconds
Standard Deviation 2.02
|
10.17 seconds
Standard Deviation 2.82
|
|
Four Square Step Test
Post-test
|
8.93 seconds
Standard Deviation 2.04
|
9.50 seconds
Standard Deviation 1.74
|
PRIMARY outcome
Timeframe: 10 weeksParticipants 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.
Outcome measures
| Measure |
Tai Chi Intervention 1
n=7 Participants
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.
Tai Chi: Physical activity requiring slow, controlled whole body movement and weight shifting.
|
Tai Chi Intervention 2
n=5 Participants
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.
Tai Chi: Physical activity requiring slow, controlled whole body movement and weight shifting.
|
|---|---|---|
|
Zeno Walkway Analysis of Gait Speed
Gait Speed Pre Test
|
1.20 meters/second
Standard Deviation .14
|
1.07 meters/second
Standard Deviation .23
|
|
Zeno Walkway Analysis of Gait Speed
Gait Speed Post Test
|
1.27 meters/second
Standard Deviation .14
|
1.17 meters/second
Standard Deviation .21
|
PRIMARY outcome
Timeframe: 10 weeksThe 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.
Outcome measures
| Measure |
Tai Chi Intervention 1
n=7 Participants
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.
Tai Chi: Physical activity requiring slow, controlled whole body movement and weight shifting.
|
Tai Chi Intervention 2
n=5 Participants
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.
Tai Chi: Physical activity requiring slow, controlled whole body movement and weight shifting.
|
|---|---|---|
|
36-item Short Form Health Survey (SF-36)
Overall Score, Pre Test
|
586.0 score on a scale
Interval 139.0 to 663.0
|
564.0 score on a scale
Interval 221.5 to 615.0
|
|
36-item Short Form Health Survey (SF-36)
Overall Score, Post Test
|
598.5 score on a scale
Interval 289.0 to 680.0
|
533.0 score on a scale
Interval 247.3 to 644.0
|
PRIMARY outcome
Timeframe: 10 weeksThe 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.
Outcome measures
| Measure |
Tai Chi Intervention 1
n=7 Participants
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.
Tai Chi: Physical activity requiring slow, controlled whole body movement and weight shifting.
|
Tai Chi Intervention 2
n=5 Participants
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.
Tai Chi: Physical activity requiring slow, controlled whole body movement and weight shifting.
|
|---|---|---|
|
Six Minute Walk Test (6MWT)
Pre-test
|
126.84 meters
Standard Deviation 29.17
|
110.70 meters
Standard Deviation 26.45
|
|
Six Minute Walk Test (6MWT)
Post-test
|
131.58 meters
Standard Deviation 30.81
|
116.52 meters
Standard Deviation 25.01
|
PRIMARY outcome
Timeframe: 10 weeksThe 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.
Outcome measures
| Measure |
Tai Chi Intervention 1
n=7 Participants
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.
Tai Chi: Physical activity requiring slow, controlled whole body movement and weight shifting.
|
Tai Chi Intervention 2
n=5 Participants
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.
Tai Chi: Physical activity requiring slow, controlled whole body movement and weight shifting.
|
|---|---|---|
|
30 Second Sit to Stand
Pre-test
|
13.14 repetitions
Standard Deviation 2.12
|
13.80 repetitions
Standard Deviation 3.84
|
|
30 Second Sit to Stand
Post-test
|
13.29 repetitions
Standard Deviation 1.50
|
14.60 repetitions
Standard Deviation 2.70
|
PRIMARY outcome
Timeframe: 10 weeksThe 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.
Outcome measures
| Measure |
Tai Chi Intervention 1
n=7 Participants
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.
Tai Chi: Physical activity requiring slow, controlled whole body movement and weight shifting.
|
Tai Chi Intervention 2
n=5 Participants
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.
Tai Chi: Physical activity requiring slow, controlled whole body movement and weight shifting.
|
|---|---|---|
|
Timed up and go Test
Pre-test
|
8.62 seconds
Standard Deviation 1.27
|
10.08 seconds
Standard Deviation 1.67
|
|
Timed up and go Test
Post-test
|
8.07 seconds
Standard Deviation 1.51
|
9.46 seconds
Standard Deviation 2.91
|
PRIMARY outcome
Timeframe: 10 weeksThe 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.
Outcome measures
| Measure |
Tai Chi Intervention 1
n=7 Participants
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.
Tai Chi: Physical activity requiring slow, controlled whole body movement and weight shifting.
|
Tai Chi Intervention 2
n=5 Participants
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.
Tai Chi: Physical activity requiring slow, controlled whole body movement and weight shifting.
|
|---|---|---|
|
Single Leg Stance Test
Eyes Closed, Right Pre-test
|
1.95 seconds
Standard Deviation 2.23
|
3.29 seconds
Standard Deviation 2.23
|
|
Single Leg Stance Test
Eyes Closed, Right Post-test
|
2.22 seconds
Standard Deviation 2.32
|
3.62 seconds
Standard Deviation 1.60
|
|
Single Leg Stance Test
Eyes Closed, Left Pre-test
|
3.71 seconds
Standard Deviation 2.29
|
5.27 seconds
Standard Deviation 4.70
|
|
Single Leg Stance Test
Eyes Closed, Left Post-test
|
8.35 seconds
Standard Deviation 10.56
|
3.53 seconds
Standard Deviation 2.17
|
Adverse Events
Tai Chi Intervention
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
William Lindblad, Director of Research and Scholarship
Husson University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place