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HypertensionHAPI-CHINCT02761603

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

A study testing Healthy Aging Practice-centered Instruction (HAPI) and Tai Chi (CHI) in people with Hypertension and Prehypertension, run by University of California, San Diego.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Hypertension, Prehypertension
What is being tested?
Healthy Aging Practice-centered Instruction (HAPI) and Tai Chi (CHI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
No sites listed yet
Study dates
Apr 2015to Dec 2022
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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.

Being tested
Healthy Aging Practice-centered Instruction (HAPI), Tai Chi (CHI)
Medical subject headings
Hypertension, Prehypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy Aging Practice-centered Instruction (HAPI)Behavioural

    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.

  • Tai Chi (CHI)Behavioural

    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

Study groups in NCT02761603
Study groupRoleWhat they receive
Healthy Aging Practice-centered Instruction (HAPI)Active comparator24 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.
Receives: Behavioral: Healthy Aging Practice-centered Instruction (HAPI)
Tai Chi (CHI)Experimental24 hours of group instruction in 8 meditative Tai Chi movements.
Receives: Behavioral: Tai Chi (CHI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Pressure

    Change From Pre-intervention to Post-intervention in Blood Pressure (mmHg)

    Measured: Pre- to post-intervention (12 weeks)

Secondary outcomes (6)

  1. Stroke Volume

    Change From Pre-intervention to Post-intervention in Stroke Volume (mL)

    Measured: Pre- to post-intervention (12 weeks)

  2. Cardiac Output

    Change From Pre-intervention to Post-intervention in Cardiac Output (mL/min)

    Measured: Pre- to post-intervention (12 weeks)

  3. Total Peripheral Resistance (TPR)

    Change From Pre-intervention to Post-intervention in TPR (mmHg·min/l)

    Measured: Pre- to post-intervention (12 weeks)

  4. Ejection Fraction (EF)

    Change From Pre-intervention to Post-intervention in EF (%)

    Measured: Pre- to post-intervention (12 weeks)

  5. Pulse Wave Velocity (PWV)

    Change From Pre-intervention to Post-intervention in PWV

    Measured: Pre- to post-intervention (12 weeks)

  6. Heart Rate Variability (HRV)

    Change From Pre-intervention to Post-intervention in HRV

    Measured: Pre- to post-intervention (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2016 (estimated)
  2. Study startApr 2015
  3. Primary completionMay 2021
  4. Study completionDec 2022 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02761603
Sponsor's protocol ID
R01HL126056
Acronym
HAPI-CHI
Status last verified
Jan 2022
First submitted
29 Apr 2016
Last updated
21 Jan 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Kohn JN, Lobo JD, Troyer EA, Wilson KL, Ang G, Walker AL, Pruitt C, Pung MA, Redwine LS, Hong S. Tai chi or health education for older adults with hypertension: effects on mental health and psychological resilience to COVID-19. Aging Ment Health. 2023 Mar;27(3):496-504. doi: 10.1080/13607863.2022.2053836. Epub 2022 Mar 21.

    PubMed 35311437

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Aging Practice-centered Instruction (HAPI) and Tai Chi (CHI) in people with Hypertension and Prehypertension, run by University of California, San Diego.

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 10 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Blood Pressure (time frame: Pre- to post-intervention (12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02761603, which also lists 1 linked publication.

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 21 Jan 2022.

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