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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

10 weeks

Results posted on

2024-10-09

Participant Flow

Participant milestones

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

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

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 20-7992-1958

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place