HypertensionNCT04407403
Health Outcomes of Two Different Tai Chi Interventions
A study testing Tai Chi tailored for lowering blood pressure (PRESSURE) and Tai Chi tailored for improving balance (BALANCE) in people with Hypertension and Fall, run by University of Connecticut at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Fall
- What is being tested?
- Tai Chi tailored for lowering blood pressure (PRESSURE) and Tai Chi tailored for improving balance (BALANCE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of the Practice of Two Tai Chi Interventions Tailored for Different Health Outcomes
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.
Read the 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.
- Conditions
- Hypertension, Fall
- Being tested
- Tai Chi tailored for lowering blood pressure (PRESSURE), Tai Chi tailored for improving balance (BALANCE)
- Keywords
- Tai Chi, Hypertension, Balance function, Older adults
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi tailored for lowering blood pressure (PRESSURE)Behavioural
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 improving balance (BALANCE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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)
The PAFF is a validated tool to assess habitual physical activity levels, including informal activities of daily living (e.g., city blocks walked, stairs climbed), leisure-time activities, and formal exercise. Activity scores in Kcal/week, and MET-minutes/week were calculated for walking, stair climbing, sport and leisure activity, and totaled. Activity scores in hours/week were calculated for sitting, light intensity, moderate intensity, and vigorous intensity activities.
Measured: 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)
The BRFS is a validated tool assess nutrient intake. It captures the nutrient intake such as dietary fat, and fiber, by collecting the frequency of consumptions of 24 food items (6 fruit/vegetable items, 3 bread/cereal items, and 15 meat/snack items). It was measured on a 5-point scale from 0 (Never, or less than once per week) to 4 (about 1 time per day or more).
Measured: 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)
The PSS is a validated tool to assess the level of perceived stress. It assesses the extent to which situations during the past month have been perceived as stressful. It has 10 individual items which are measured on a 6-point scale from 0 (never) to 5 (very often).
Measured: 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)
The GAI is validated tool to assess level of anxiety. It assesses typical common anxiety symptoms. The measurements of somatic symptoms with the instrument are limited in order to minimize confusion between symptoms common to anxiety and general medical conditions. This questionnaire has 20 individual questions that were answered as "agree" or "disagree".
Measured: 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)
The HGT is a validated test as an indicator of overall body strength. The HGT was performed on the dominant arm with a calibrated Jamar Hydraulic Handgrip Dynamometer model 5030J1 (Lafayette Instrument Co., Lafayette, IN) in its second handle position. Participants were sitting with the arm against the trunk and the elbow flexed 90 degrees on the tested side.
Measured: 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.
Change in the 30-Second Sit-to-Stand Test (STS)
The STS is a validated test for assessing lower extremity strength. Participants were sitting in a standard padded chair (43.20 cm) without armrests and performed the test with both arms crossed against the chest. Participants started from the seated position, and then stood up until legs were straight and sat down with full weight placed on the chair. Investigators counted the number of chair stands completed in 30 seconds.
Measured: 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.
Change in the Chair Sit-and-Reach Test (CSRT)
The CSRT is a validated test for assessing hamstring flexibility. Participants sat in a chair with one leg extended and the other bent, then reached down and forward slowly in an attempt to touch the toes of the extended leg. Participants held a brief static position for 2 seconds, while investigators recorded the distance between the tips of the middle fingers and the middle of the toe at the end of the shoe in cm using an 18-inch (46 cm) ruler positioned parallel to the shin.
Measured: 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.
Change in the 10-Meter Walk Test (10MWT)
: The 10-Meter Walk Test is a validated test for assessing participants' walking speed which is an important indicator of survival rates of older adults. Participants walked as fast as possible through a 15-meter walking path with 2.5 meters provided for acceleration and deceleration on each end. Investigators measured the seconds used to pass the data collection area at 10 meters with a handheld stopwatch. The fast walking speed (cm/second) was calculated for data analysis.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Nov 2017
- Primary completion16 May 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Pescatello, University of Connecticut
- Investigators
- Linda Pescatello, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407403
- Sponsor's protocol ID
- H16-262
- Status last verified
- May 2020
- First submitted
- 22 May 2020
- Last updated
- 29 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Practice of Two Tai Chi Interventions Tailored for Different Health Outcomes
- ClinicalTrials.gov ID
- NCT04407403
- Acronym / sponsor ID
- H16-262
- Conditions
- Hypertension, Fall
- Keywords
- Tai Chi, Hypertension, Balance function, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tai Chi tailored for lowering blood pressure (PRESSURE) | Experimental | Behavioral: Tai Chi tailored for lowering blood pressure (PRESSURE)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. |
| Tai Chi tailored for improving balance (BALANCE) | Experimental | Behavioral: Tai Chi tailored for improving balance (BALANCE)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. |
| 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi tailored for lowering blood pressure (PRESSURE)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. | Behavioural | Tai Chi tailored for lowering blood pressure (PRESSURE) |
| Tai Chi tailored for improving balance (BALANCE)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. | Behavioural | Tai Chi tailored for improving balance (BALANCE) |
Primary outcome
Change in Resting Blood Pressure (BP)
Time frame: 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.
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.
Change in the Single Leg Stance Test (SLS)
Time frame: 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.
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.
Change in the Timed Up and Go Test (TUG)
Time frame: 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.
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.
Change in the Four Square Step Test (FFS)
Time frame: 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.
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.
Change in the Postural Stability Test (PST)
Time frame: 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.
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.
Change in the Limits of Stability Test (LST)
Time frame: 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.
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).
Change in the Modified Clinical Test of Sensory Interaction and Balance (CTSIB)
Time frame: 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.
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).
8 secondary outcomes
Change in the Paffenbarger Physical Activity Questionnaire (PAFF)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Change in the 30-Second Sit-to-Stand Test (STS)
Time frame: 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.
Change in the Chair Sit-and-Reach Test (CSRT)
Time frame: 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.
Change in the 10-Meter Walk Test (10MWT)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Pescatello, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi tailored for lowering blood pressure (PRESSURE) and Tai Chi tailored for improving balance (BALANCE) in people with Hypertension and Fall, run by University of Connecticut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Resting Blood Pressure (BP) (time frame: 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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.