What side effects are associated with this type of intervention?

Common treatments for high blood pressure include antihypertensive medications and lifestyle modifications. Antihypertensive medications, such as ACE inhibitors, beta-blockers, diuretics, and calcium channel blockers, can have side effects including dizziness, fatigue, headaches, and gastrointestinal issues. Non-pharmacologic treatments like Tai Chi, which is being studied for its potential to reduce blood pressure and improve cognitive function, generally have fewer side effects. Tai Chi is considered safe and may improve balance, reduce stress, and enhance overall well-being, with minimal adverse effects reported.

What prior FDA approvals exist?

The FDA has approved various pharmacologic treatments for high blood pressure, including ACE inhibitors, beta-blockers, calcium channel blockers, and diuretics. However, non-pharmacologic treatments like Tai Chi, which have shown potential in reducing blood pressure and improving cognitive function, are not typically subject to FDA approval. Tai Chi and similar meditative movement therapies, such as qigong and yoga, have demonstrated benefits in lowering blood pressure and enhancing cognitive function, particularly executive function, through mechanisms that may involve improved brain structure and function. These therapies are often recommended as complementary approaches to traditional pharmacologic treatments.

What other types of research exist?

Promising alternatives to Tai Chi for high blood pressure patients include Baduanjin exercise and combined physical exercise with cognitive training. Baduanjin has been shown to improve cognitive function in stroke survivors with cognitive impairment. Combined physical exercise and cognitive training have demonstrated benefits in cognitive function for stroke survivors with vascular cognitive impairment. Both interventions are nonpharmacological and may offer similar benefits to Tai Chi in terms of reducing blood pressure and enhancing cognitive function.

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Tai Chi for High Blood Pressure and Cognitive Function (ACTION Trial)

N/A

Waitlist Available

Led By Linda S Pescatello, PhD

Research Sponsored by University of Connecticut

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up acute change in the flanker will be calculated as (post - pre-tai chi session flanker in acute exercise visit a or b) minus (post - pre-sham control session flanker in control and mri visit a or b).

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how Tai Chi, a gentle exercise, affects blood pressure and brain function in older adults with high blood pressure. Participants will do Tai Chi online for a few months. Researchers aim to see if lowering blood pressure through Tai Chi can improve thinking skills needed for daily tasks. Tai Chi is an ancient Chinese internal martial art that has increased in popularity across the United States over the past 2 decades.

Who is the study for?

This trial is for postmenopausal women with high blood pressure who have finished high school or equivalent, are not regular exercisers, and have no recent Tai Chi experience. They must be non-smokers, drink less than two alcoholic drinks daily, and have internet access. Those with certain chronic diseases, a history of drug use or taking specific medications may be excluded.

What is being tested?

The ACTION study tests if practicing Tai Chi can lower blood pressure and improve cognitive function in older women with hypertension. It involves measuring the effects of a single session and a 12-week online program on heart health and brain function, particularly executive skills.

What are the potential side effects?

Tai Chi is generally considered safe with minimal risk of side effects. However, participants might experience muscle soreness or strain from new physical activity. Since it's gentle exercise, serious side effects are unlikely.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ chronic change in the scwt will be calculated as scwt measured at visit 7 in week 15 (pre-tai chi session in the acute exercise visit b) minus the scwt measured at visit 4 or 5 in week 2 (pre-tai chi session in the acute exercise visit a).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~chronic change in the scwt will be calculated as scwt measured at visit 7 in week 15 (pre-tai chi session in the acute exercise visit b) minus the scwt measured at visit 4 or 5 in week 2 (pre-tai chi session in the acute exercise visit a).

This trial's timeline: 3 weeks for screening, Varies for treatment, and chronic change in the scwt will be calculated as scwt measured at visit 7 in week 15 (pre-tai chi session in the acute exercise visit b) minus the scwt measured at visit 4 or 5 in week 2 (pre-tai chi session in the acute exercise visit a). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Chronic Change in Ambulatory Blood Pressure (BP)

Magnetic Resonance Imaging

Chronic Change in Resting Systolic and Diastolic Blood Pressure (BP)

+6 more

Secondary study objectives

Body Weight Changes

Bronchial Provocation Tests

Acute Change in the Computerized California Assessment Package-Abbreviated Version (CalCAP)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Tai Chi groupExperimental Treatment1 Intervention

During the 12-week online Tai Chi intervention, participants in the Tai Chi group will attend live online Tai Chi sessions led by a certified Tai Chi instructor for 3 sessions/week, 45 minutes/session for 12 weeks. The participants will also practice Tai Chi offline between sessions using instructional videos that will be shared with them at the end of each live online Tai Chi session. Participants in the Tai Chi group will be instructed: 1) to maintain their regular level of physical activity outside of the live online Tai Chi exercise sessions and offline Tai Chi exercise, and diet during the study; and 2) to inform the researchers when there is a change(s) in a medical condition or medication prescribed.

Group II: controlActive Control1 Intervention

Participants in the control group will perform only their regular habitual daily activities throughout the 12 weeks of intervention period. Participants in the control group will be 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tai Chi

2014

Completed Phase 2

~1660

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure include lifestyle modifications, medications, and alternative therapies like Tai Chi. Lifestyle changes such as diet and exercise improve cardiovascular health by reducing arterial stiffness and promoting better blood flow. Medications like ACE inhibitors, beta-blockers, and diuretics work by relaxing blood vessels, reducing heart rate, and decreasing blood volume, respectively. Tai Chi, a low-impact exercise, reduces blood pressure by enhancing relaxation, improving blood flow, and potentially altering brain structure and function, which also benefits cognitive function. These mechanisms are crucial for high blood pressure patients as they help manage blood pressure levels, reduce the risk of cardiovascular events, and improve overall quality of life.

Analysis of Clinical Efficacy of Traditional Chinese Medicine in Recovery Stage of Stroke: A Systematic Review and Meta-Analysis.A systematic review and meta-analysis of buyang huanwu decoction in animal model of focal cerebral ischemia.The effect of Chinese food therapy on community dwelling Chinese hypertensive patients with Yin-deficiency.