Health Outcomes of Two Different Tai Chi Interventions

NCT04407403 | Completed

• 1 other identifier: H16-262
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Tai Chi results in numerous health benefits but whether it can be tailored to elicit different health outcomes is not clear. Therefore, investigators compared the health benefits of two different Tai Chi interventions tailored for improvements in blood pressure (BP) (PRESSURE) or balance (BALANCE). Investigators tailored PRESSURE to emphasize breathing techniques and mental relaxation and BALANCE to emphasize movement principles that challenged balance. Participants were randomized to PRESSURE (n=12), BALANCE (n=13), or CONTROL (n=10). Tai Chi was practiced 3 sessions/week, 60 minute/session for 12 weeks. CONTROL performed normal daily activities. Investigators tested the change in cardiometabolic health, balance, and functional fitness outcomes among groups. Investigators hypothesized that PRESSURE would elicit greater BP reductions compared to BALANCE; meanwhile, BALANCE would elicit greater improvements in balance measures than PRESSURE.

Conditions

Hypertension; Fall

Keywords

Tai Chi; Hypertension; Balance function; Older adults

Outcome Measures

Primary Outcomes (7)

• Change in Resting Blood Pressure (BP)

  Investigators measured resting systolic BP (SBP) and resting diastolic BP (DBP) according to standards set by the American Heart Association using the OMRON automated BP monitors model HEM-705CPN in mmHg.

  Changes in resting SBP and DBP were calculated as the post-intervention resting BP measured at Visit 3 in week 14 minus the pre-intervention resting BP measured at Visit 2 in week 1.

• Change in the Single Leg Stance Test (SLS)

  The SLS is a validated clinical test to measure static balance. Participants balanced on their dominant leg for as long as they can without any assistance from the ground or other objects. Investigators measured the seconds of successful balance using a handheld stopwatch.

  Changes SLS were calculated as the post-intervention SLS measured at Visit 3 in week 14 minus the pre-intervention SLS measured at Visit 2 in week 1.

• Change in the Timed Up and Go Test (TUG)

  The TUG is a valid clinical test that was developed to assess dynamic balance and mobility in older adults. Following the word "Go", participants stood up from a standard chair (46 cm seat height, 65 cm armrest height), walk three meters as quickly as they could to a mark on the floor, turn and sit back down to the chair. Investigators measured the seconds used to finish the trial using a handheld stopwatch.

  Changes in TUG were calculated as the post-intervention TUG measured at Visit 3 in week 14 minus the pre-intervention TUG measured at Visit 2 in week 1.

• Change in the Four Square Step Test (FFS)

  The FFS is a validated dynamic standing balance test that puts high demand on the ability to plan and recall movements and execute those movements in a correct sequence. During the test, participants were asked to step in a predetermined sequence over four 90-cm-long walking sticks, placed in a cross configuration on the ground. The participant's starting position is in square 1 facing square 2. Then, the participant stepped forward, to the right, backward, and to the left into each quadrant in the clockwise direction, followed by the reverse sequence in the counterclockwise direction (i.e., the sequence 2, 3, 4, 1, 4, 3, 2, 1). Participants were instructed to complete the sequence as fast as possible without touching the sticks. Investigators measured the seconds used to finish the trial using a handheld stopwatch.

  Changes in FFS were calculated as the post-intervention FFS measured at Visit 3 in week 14 minus the pre-intervention FFS measured at Visit 2 in week 1.

• Change in the Postural Stability Test (PST)

  The PST is a validated test to assess overall ability to maintain center of mass. It was administered using the Biodex Balance System SD (BBS) (Biodex Medical Systems, Shirley, USA). Investigators used the default setting that the stability of the platform was set on 8 (12 is the most stable, and 1 is the least stable). Participants stood on the platform with both feet and remain as still as possible. Each participant performed three 20-second trials, with ten seconds rest between trials. The BBS software (Biodex Medical Systems, Inc., version 1.3.4) calculated the medial-lateral stability index, the anterior-posterior stability index, and the overall stability index.

  Changes in PST were calculated as the post-intervention PST measured at Visit 3 in week 14 minus the pre-intervention PST measured at Visit 2 in week 1.

• Change in the Limits of Stability Test (LST)

  The LST is a validated test to assess functional stability limits, and anticipatory postural control. The LST was administered with the Biodex Balance System SD (BBS) (Biodex Medical Systems, Shirley, USA) following default settings. Reflecting the movement of the center of mass, a cursor on the screen in front of the participants were moved from a central circle to eight peripheral circles appearing successively in a random order on the screen. Participant were instructed to start moving the cursor toward the flashing target. The cursor had to stay within the target circle for a minimum of 0.5 seconds before it disappeared and showed the next target on the screen. Each trial ended when the eight target circles have been reached and the cursor repositioned in the central circle. The overall dynamic limit-of-stability score and the eight individual directional dynamic limit-of stability scores were calculated by the BBS software (Biodex Medical Systems, Inc., version 1.3.4).

  Changes in LST were calculated as the post-intervention LST measured at Visit 3 in week 14 minus the pre-intervention LST measured at Visit 2 in week 1.

• Change in the Modified Clinical Test of Sensory Interaction and Balance (CTSIB)

  The CTSIB is a valid clinical assessment for investigating the sensory organization inputs in postural control. The CTSIB was administered with the Biodex Balance System SD (BBS) (Biodex Medical Systems, Shirley, USA) following default settings. Participants stood on the platform with both feet under four conditions: 1) eyes opened on firm surface; 2) eyes closed on firm surface; 3) eyes opened on a dynamic surface; and 4) eyes closed on dynamic surface. Each condition lasted 30 seconds with 10 seconds in between. A sway index was calculated for each of the four conditions by the BBS software (Biodex Medical Systems, Inc., version 1.3.4).

  Changes in CTSIB were calculated as the post-intervention CTSIB measured at Visit 3 in week 14 minus the pre-intervention CTSIB measured at Visit 2 in week 1.

Secondary Outcomes (8)

• Change in the Paffenbarger Physical Activity Questionnaire (PAFF)

  Changes in PAFF were calculated as the post-intervention PAFF measured at Visit 3 in week 14 minus the pre-intervention PAFF measured at Visit 1 in week 1.

• Change in the Block Rapid Food Screener (BRFS)

  Changes in BRFS were calculated as the post-intervention BRFS measured at Visit 3 in week 14 minus the pre-intervention BRFS measured at Visit 1 in week 1.

• Change in the Perceived Stress Scale Short Form (PSS)

  Changes in PSS were calculated as the post-intervention PSS measured at Visit 3 in week 14 minus the pre-intervention PSS measured at Visit 1 in week 1.

• Change in the Geriatric Anxiety Inventory (GAI)

  Changes in GAI were calculated as the post-intervention GAI measured at Visit 3 in week 14 minus the pre-intervention GAI measured at Visit 1 in week 1.

• Change in the Hand Grip Test (HGT)

  Changes in HGT were calculated as the post-intervention HGT measured at Visit 3 in week 14 minus the pre-intervention HGT measured at Visit 2 in week 1.

Study Arms (3)

Tai Chi tailored for lowering blood pressure (PRESSURE)

EXPERIMENTAL

During the 12-week Tai Chi intervention, participants in the PRESSURE group attended supervised Tai Chi sessions led by a certified Tai Chi instructor for 3 sessions/week, 60 minutes/session for 12 weeks. In addition, participants in the PRESSURE group were instructed: 1) to maintain their regular level of physical activity outside of the supervised Tai Chi exercise sessions, and diet during the study; and 2) to inform the researchers when there is a change(s) in a medical condition or medication prescribed.

Behavioral: Tai Chi tailored for lowering blood pressure (PRESSURE)

Tai Chi tailored for improving balance (BALANCE)

EXPERIMENTAL

During the 12-week Tai Chi intervention, participants in the BALANCE group attended supervised Tai Chi sessions led by a certified Tai Chi instructor for 3 sessions/week, 60 minutes/session for 12 weeks. In addition, participants in the BALANCE group were instructed: 1) to maintain their regular level of physical activity outside of the supervised Tai Chi exercise sessions, and diet during the study; and 2) to inform the researchers when there is a change(s) in a medical condition or medication prescribed.

Behavioral: Tai Chi tailored for improving balance (BALANCE)

control group (CONTROL)

NO INTERVENTION

During the 12-week Tai Chi intervention, participants in the CONTROL group performed their regular daily activities. In addition, participants in the CONTROL group were instructed: 1) to maintain their regular level of physical activity and diet during the study; and 2) to inform the researchers when there is a change(s) in a medical condition or medication prescribed. Of note, both PRESSURE and BALANCE were offered to participants assigned in the CONTROL group after data collection was completed.

Interventions

Tai Chi tailored for lowering blood pressure (PRESSURE) BEHAVIORAL

PRESSURE Tai Chi routine consisted of eight forms following Yang style. PRESSURE was tailored for the targeted health outcome of BP in consultation with the professional, certified Tai Chi instructor and an experienced physical therapist. Specifically, investigators tailored PRESSURE to emphasize slow, deep breathing and relaxation by utilizing Tai Chi movements that: 1) were slow and smooth; 2) without break or pause; and 3) had minimal muscular force and exertion. Investigators included the following eight forms in PRESSURE: 1) Begin Tai Ji Quan; 2) Part the Horse's Mane; 3) Brush Knee and Push; 4) Cloud Hands; 5) Open and Close; 6) Part the Grass; 7) Single Whip; and 8) Finish Tai Ji Quan.

Tai Chi tailored for lowering blood pressure (PRESSURE)

Tai Chi tailored for improving balance (BALANCE) BEHAVIORAL

BALANCE Tai Chi routine consisted of eight forms following Yang style. BALANCE was tailored for the targeted health outcome of balance in consultation with the professional, certified Tai Chi instructor and an experienced physical therapist. Specifically, investigators tailored BALANCE to provide moderate to high levels of challenge to balance control by emphasizing movement principles (e.g., consciously control weight shifting during multi-directional stepping), and integrating Tai Chi movements that: 1) reduced the base of support; 2) moved the center of gravity; and 3) improved lower-extremity strength. Investigators included the following eight forms in BALANCE: 1) Begin Tai Ji Quan; 2) Roll the Ball; 3) Kick with Heel; 4) Repulse the Monkey; 5) Gather the Earth's Qi; 6) White Crane Spread Wing; 7) Fairy Weaves the Shuttle; and 8) Finish Tai Ji Quan.

Tai Chi tailored for improving balance (BALANCE)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant was enrolled in one of the three programs at Seabury including: the Seabury at Home program, the Independent Living program, and the Assisted Living program.
• The participant was 50 or older, which was the age limit to be enrolled in any Seabury programs.
• The participant was ambulatory without using an assistive device (e.g., walkers, canes, crutches).

You may not qualify if:

• \. Older adults who enrolled in the Memory Support Assisted Living program or the Skilled Nursing program at Seabury were not invited to participate because Tai Chi practice could be too cognitively and/or physically challenging for them.
• \. To ensure the safety of exercise and avoid potential exercise-related cardiac events, if the participant had blood pressure (BP) be systolic BP \<90 and/or systolic BP ≥160 mmHg and/or diastolic BP \<60 and/or diastolic BP ≥100 mmHg during screening, this participant was excluded from further participation.
• \. Participants were removed from the study if they were not willing to comply with all study procedures. Participants were also removed from the study in the event of injury, illness, or other change that may influence the outcome variables being measured.

Sponsors & Collaborators

• University of Connecticut: lead

Study Sites (1)

Seabury

Bloomfield, Connecticut, 06002, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Pressure

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Linda Pescatello, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 29, 2020
• Study Start: November 1, 2017
• Primary Completion: May 16, 2018
• Study Completion: November 30, 2018
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)