Healthy Aging Practice-centered Instruction Cardiovascular Health Investigation (HAPI-CHI) (HAPI-CHI)

Autonomic and Immuno-Vascular Mechanisms of Antihypertensive Effects of Tai Chi

Over 30% of American adults have hypertension (HTN) (high blood pressure), and the rate increases considerably with age; 64% of men and 78% of women over 65 have HTN. High blood pressure associated with HTN can force of the blood against artery walls with enough pressure that it can eventually cause health problems, such as heart disease and stroke. HTN is one of the most significant causes of early death worldwide and one of the most preventable causes of death. Many studies reveal that lowering blood pressure (BP) reduces the incidence of diseases of the heart and blood vessels. Non-drug related treatments are known to reduce BP which can have a great effect on public health. Research suggests that Tai Chi (TC) is effective in lowering BP in patients with HTN, but because of the low quality of existing studies there is no definite proof. Also, it is not known how TC reduces BP. One possibility is that TC practice, which is shown to reduce psychological distress such as anxiety and depression and reduce the body's responses to stress, can improve the balance of the autonomic nervous system (the part of your nervous system that controls beating of the heart and the widening or narrowing of blood vessels). This may lead to lower BP. The investigators plan to investigate the pathways among autonomic, blood vessel, immune and psychological factors in relation to BP changes in response to 12-weeks of TC compared with Healthy Aging Practice-centered Education (HAP-E). 250 older adults (60+ years old) with mild HTN will be enrolled, and the investigators will take several measurements of heart and nervous system functioning. The investigators hypothesize that performing TC for 12 weeks will result in autonomic "re-regulation" which will improve BP and blood vessel health (Aim 1) and sympathetic nervous system (part of the nervous system that serves to speed up heart rate, contract blood vessels, and raise blood pressure) regulation of the immune system (Aim 2). Lastly, the investigators hypothesize that psychological factors will be related to TC effects on autonomic regulation (Aim 3). Findings from the investigators study will hopefully shed light on the pathways by which TC reduces BP. Also, the particular effects of TC ("meditative movement") in an older, "hard-to-treat" hypertensive population will be better understood.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hypertension; Prehypertension
• Intervention / Treatment: Behavioral: Healthy Aging Practice-centered Instruction (HAPI); Behavioral: Tai Chi (CHI)

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 1. SBP≥130 but overall BP ≤ 170/110;
2. Able to perform light to moderate exercise;
3. Able to give informed consent;
4. Able to complete study assessments as described;
5. Understand study procedures and to comply with them for the entire length of the study;
6. 5. 60+ years;
7. Able to complete written questionnaires without assistance (reading devices okay);
8. Have not had a fall in that resulted in hospitalization in the past 12 months;
9. Willing to be randomized to TC or HAP-E;
10. Able to attend regular study activities at the center and/or UCSD.

Exclusion Criteria:

1. Currently performing meditation for more than 15 minutes at a time 2X/week or more);
2. Currently performing moderate exercise (enough to work up a sweat) for more than 15 minutes 2X/week or more.
3. Oxygen-dependent COPD;
4. Stroke, cerebral neurologic impairment, cardiac surgery or MI within the past year;
5. Current use of mood stabilizers, or antipsychotics;
6. Medications (steroids) and conditions affecting our immune assays or our physiological measures of vascular function (anti-cholinergics);
7. Severe kidney disease;
8. Current cancer diagnosis or treatment;
9. Insulin-dependent diabetes mellitus;
10. Meets criteria for bipolar disorder, schizophrenia, substance use disorder;
11. Suicidality;
12. Inability to read and write in English;
13. Inability to provide written informed consent;
14. Inability to adequately answer questions on the post-consent assessment;
15. Current smoker;
16. Body Mass Index > 40 kg/m2;
17. Currently meets criteria for major depressive episode (per patient self-report of clinical diagnosis by a professional);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy Aging Practice-centered Instruction (HAPI); 24 hours of group instruction in which experts present on a variety of health-related topics followed by class discussion, goal-setting, and goal review. Themes will include: sleep, nutrition, mental health, social support, bone-health, diabetes prevention, cognitive wellness, and resilience.	Behavioral: Healthy Aging Practice-centered Instruction (HAPI); Sessions will include interactive activities derived from the CDC's "Program to Encourage Active and Rewarding LiveS (PEARLS)" and will include lectures based on health-related topics from presentations given by experts as part of the UC San Diego Stein Institute of Aging's Successful Aging project. The PEARLS Problem Solving Treatment (PST) group discussions will be facilitated by a trained instructor in order for participants to identify problems or barriers they have in engaging in healthy behaviors relevant to each of 12 topic areas (e.g. sleep, nutrition, mental health, social support, bone health, diabetes prevention, cognitive wellness, and resilience). Each session will be composed of: Successful Aging video (45 min), discussion (40 min), and identifying problem solving strategies (25 min) with a homework assignment each week, for a total of 24 hours of in-class instruction and discussion.
Experimental: Tai Chi (CHI); 24 hours of group instruction in 8 meditative Tai Chi movements.	Behavioral: Tai Chi (CHI); Sessions will include expert instruction in the brief Yang-style 8-form Tai Chi meditative movements. Each class will include a 10-minute warm-up and cool-down plus 40 minutes of Tai Chi instruction and or practice, for a total of 24 hours of in-class instruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Change From Pre-intervention to Post-intervention in Blood Pressure (mmHg)	Pre- to post-intervention (12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Volume	Change From Pre-intervention to Post-intervention in Stroke Volume (mL)	Pre- to post-intervention (12 weeks)
Cardiac Output	Change From Pre-intervention to Post-intervention in Cardiac Output (mL/min)	Pre- to post-intervention (12 weeks)
Total Peripheral Resistance (TPR)	Change From Pre-intervention to Post-intervention in TPR (mmHg·min/l)	Pre- to post-intervention (12 weeks)
Ejection Fraction (EF)	Change From Pre-intervention to Post-intervention in EF (%)	Pre- to post-intervention (12 weeks)
Pulse Wave Velocity (PWV)	Change From Pre-intervention to Post-intervention in PWV	Pre- to post-intervention (12 weeks)
Heart Rate Variability (HRV)	Change From Pre-intervention to Post-intervention in HRV	Pre- to post-intervention (12 weeks)

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): May 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 29, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Prehypertension
• Other Study ID Numbers: R01HL126056 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO