Clinical trial NCT04407403: Health Outcomes of Two Different Tai Chi Interventions
Official title: A Comparison of the Practice of Two Tai Chi Interventions Tailored for Different Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Fall
Keywords: Tai Chi
Hypertension
Balance function
Older adults
Lead sponsor: University of Connecticut
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 42
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: By 2030, older adults (≥65 years) will comprise approximately 20% (\~72 million) of the United States (US) population. Currently in the US, over 70% of older adults have hypertension, and approximately 30% of healthy US older adults experience a fall annually. Therefore, preventing and treating high blood pressure (BP) and improving balance to reduce falling are priorities for healthy aging. Tai Chi is a low impact, social, and enjoyable form of exercise that is particularly suitable for older adults. In addition, BP and balance are the two most studied health outcomes of Tai Chi. Of note, Tai Chi varies considerably in terms of the styles (e.g., Yang), forms (e.g., cloud hands), and combinations of breathing techniques, mental relaxation, and movement principles. However, Tai Chi is rarely tailored for the health outcomes being targeted in research studies. Therefore, it is still unclear if healthcare professionals should recommend or design specific types of Tai Chi practice based on the health outcomes being targeted to maximize the benefits.

Investigators compared two different Tai Chi interventions, one tailored for reductions in BP (PRESSURE) and the other for improvements in balance (BALANCE) for their resultant health benefits among community dwelling older adults. Investigators hypothesized that PRESSURE would elicit statistically significantly greater BP reductions compared to BALANCE; meanwhile, BALANCE would elicit statistically significantly greater improvements in balance measures than PRESSURE.

All participants participated in three research visits. Visit1, and Visit 2 before, and Visit 3 after the 12-week Tai Chi exercise intervention or control group assignments. During Visit 1, investigators: 1) measured resting BP and completed the screening checklist; 2) administered questionnaires assessing life style habits (i.e., the Paffenbarger Physical Activity Questionnaire, the Block Rapid Food Screener, the Pittsburgh Sleep Quality Index), mental health (i.e., the Perceived Stress Scale Short Form, the Geriatric Anxiety Inventory); and 3) gave participants accelerometers to wear at home for 96 consecutive hours to measure habitual physical activity levels. Between Visits 1 and 2, investigators: 1) obtained medical clearance for all participants; and 2) perform the randomization of participants. During Visit 2, investigators assessed balance function (i.e., the Single Leg Stance Test, the Timed Up and Go Test, the Four Square Step Test, the Postural Stability Test, the Limits of Stability Test, the Modified Clinical Test of Sensory Interaction and Balance Test); BP; and functional fitness (i.e., the Hand Grip Test, the 30-Second Sit-to-Stand Test, the Chair Sit-and-Reach Test, the 10-Meter Walk Test). During the 12-week Tai Chi exercise intervention or control group assignments, participants assigned to BALANCE and PRESSURE groups were asked to attend Tai Chi exercise sessions for 3 sessions/week 60 minutes/session. Participants assigned to the control group did attend Tai Chi exercise sessions and were asked to maintain their regular level of physical activity. During Visit 3, investigators administered all measurements completed in Visit 2, and questionnaires administered in Visit 1.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. The participant was 50 or older, which was the age limit to be enrolled in any Seabury programs.
3. The participant was ambulatory without using an assistive device (e.g., walkers, canes, crutches).

Exclusion Criteria:

* 1. 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.

  2. 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.

  3. 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.

Primary outcomes:
measure: Change in Resting Blood Pressure (BP)
timeFrame: 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.
measure: Change in the Single Leg Stance Test (SLS)
timeFrame: 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.
measure: Change in the Timed Up and Go Test (TUG)
timeFrame: 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.
measure: Change in the Four Square Step Test (FFS)
timeFrame: 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.
measure: Change in the Postural Stability Test (PST)
timeFrame: 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.
measure: Change in the Limits of Stability Test (LST)
timeFrame: 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.
measure: Change in the Modified Clinical Test of Sensory Interaction and Balance (CTSIB)
timeFrame: 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:
measure: Change in the Paffenbarger Physical Activity Questionnaire (PAFF)
timeFrame: 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.
measure: Change in the Block Rapid Food Screener (BRFS)
timeFrame: 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.
measure: Change in the Perceived Stress Scale Short Form (PSS)
timeFrame: 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.
measure: Change in the Geriatric Anxiety Inventory (GAI)
timeFrame: 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.
measure: Change in the Hand Grip Test (HGT)
timeFrame: 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.
measure: Change in the 30-Second Sit-to-Stand Test (STS)
timeFrame: Changes in STS were calculated as the post-intervention STS measured at Visit 3 in week 14 minus the pre-intervention STS measured at Visit 2 in week 1.
measure: Change in the Chair Sit-and-Reach Test (CSRT)
timeFrame: Changes in CSRT were calculated as the post-intervention CSRT measured at Visit 3 in week 14 minus the pre-intervention CSRT measured at Visit 2 in week 1.
measure: Change in the 10-Meter Walk Test (10MWT)
timeFrame: Changes in 10MWT were calculated as the post-intervention 10MWT measured at Visit 3 in week 14 minus the pre-intervention 10MWT measured at Visit 2 in week 1.
Other outcomes:
Locations:
city: Bloomfield
country: United States
facility: Seabury
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Linda Pescatello, PhD
role: PRINCIPAL_INVESTIGATOR
References: