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Cardiovascular Diseases in Old AgeNCT06235658

Yoga in Older Cardiac Patients

A study testing Gentle Yoga in people with Cardiovascular Diseases in Old Age, run by Geunyeong Cha at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to compare, at 3 months, the effects of a yoga intervention on physical health, including balance, muscle strength, physical activity levels, cardiac autonomic function, and physical vulnerability, as well as psychological health, including depressive symptoms and anxiety, in cardiac… Read more about this study

Who is it for?
Ages 65 to 100 years
Conditions the study is for
Cardiovascular Diseases in Old Age
What is being tested?
Gentle Yoga
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
15 Nov 2023to 26 Nov 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 65 to 100 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • have a history of an acute myocardial infarction within the preceding year, stable angina, cardiac surgery (including heart transplantation, valve surgery, or coronary artery bypass), coronary artery angioplasty or stents, or heart failure (ejection fraction < 35%) diagnosed in the past year
  • have completed facility-based cardiac rehabilitation program (phase CR-II) within 12 months
  • can read and understand English
  • have no major comorbidities limiting their ability to participate in a yoga intervention
  • reside in Kentucky.

Who cannot join

  • have incapacitating neurologic, orthopedic, or neoplastic conditions such as stroke paralysis, terminal cancer, or a cognitive disorder
  • currently practice yoga
  • have no home WIiFi access

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Kentucky

    Lexington, Kentucky, 40526

Other trials in United States

About this study

Official title: Effects of Yoga on Physical and Psychological Outcomes in Older Patients Discharged From Cardiac Rehabilitation: A Pilot Study

The goal of this clinical trial is to compare, at 3 months, the effects of a yoga intervention on physical health, including balance, muscle strength, physical activity levels, cardiac autonomic function, and physical vulnerability, as well as psychological health, including depressive symptoms and anxiety, in cardiac patients who are older than 65 years old and randomized to the intervention or control group. The main questions aim to 1) determine if yoga can improve physical health outcomes such as balance, muscle strength, cardiac function, and physical vulnerability in older adults with cardiovascular disease, and 2) determine if yoga can positively impact psychological health, including reducing depressive symptoms and anxiety in this population. Participants in the intervention group will attend yoga sessions twice a week for three months. The intervention group will be asked to complete surveys and physical function assessments at the beginning and three months later. Researchers will compare the intervention group and the control group to see if there is any difference and improvement in physical and psychological health between the two groups.

Being tested
Gentle Yoga
Keywords
Physical Activity, Yoga, Mind-body therapies
Medical subject headings
Motor Activity

What participants receive

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

  • Gentle YogaBehavioural

    Participants will attend two virtual 60-minute gentle yoga sessions per week for 12 weeks. Each session will be conducted via videoconference using the Zoom platform, with participants joining from their homes.

Study groups in NCT06235658
Study groupRoleWhat they receive
ControlNo interventionParticipants in the control group will not receive any intervention but will be provided with printed or electronic versions of the American Heart Association's 'Life's Essential 8' at baseline, which includes information on how to improve and maintain cardiovascular health.
Online Yoga InterventionExperimentalParticipants in the intervention group will attend two virtual 60-minute gentle yoga sessions per week for 12 weeks.
Receives: Behavioral: Gentle Yoga

What is being measured

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

  1. Recruitment Rate

    The recruitment rate (%) will be calculated by dividing the total number of patients enrolled by approached eligible patients and then multiplying it by 100.

    Measured: Three months

  2. Number of Participants Who Completed the Study

    The completion rate of the study will be calculated by dividing the total number of patients by the number of patients who will complete the study and then multiplying it by 100.

    Measured: Three months

  3. Intervention Adherence Rate

    The intervention adherence rate will be calculated by dividing the total number of sessions attended by the total number of intervention sessions (i.e., 24) and multiplying that number by 100.

    Measured: Three months

  4. Intervention Acceptability

    The investigators will use modified versions of the Treatment Acceptability Adherence Scale (TAAS) to assess acceptability of the yoga intervention at 3-months follow-up. The TAAS is a 10-item self-report questionnaire designed to evaluate treatment acceptability and adherence. Items are rated on a 7-point Likert-type scale (1 = disagree strongly; 7 = agree strongly). The total score is a sum of ten items, ranging from 10 to 70 where a higher score means greater adherence.

    Measured: Three months

  5. Intervention Satisfaction

    The investigators will use modified versions of the Client Satisfaction Questionnaire (CSQ) to assess the satisfaction of the yoga intervention at 3-month follow-up. The CSQ is an 8-item self-report questionnaire to evaluate participant satisfaction with a specific intervention. Items are rated on a 4-point Likert-type scale (1 = very satisfied; 4= quite dissatisfied). The total score is the sum of eight items, ranging from 8 to 32, where a higher score indicates greater satisfaction with the intervention. This instrument was validated for patients and has internal consistency reliability.

    Measured: Three months

Secondary outcomes (8)
  1. Change in Patient Health Questionnaire-9

    The Patient Health Questionnaire-9 (PHQ-9) was developed to correspond to symptoms used in the DSMV-IV to diagnose clinical depression. Nine symptoms are rated on a 4-point Likert scale (0 = 'Not at all; 3 = 'Nearly every day'), with possible total scores ranging from 0 to 27 and higher scores indicating higher levels of depressive symptoms.

    Measured: Baseline and Three months

  2. Change in Brief Symptom Inventory

    The Brief Symptom Inventory (BSI), anxiety index, consists of 6 items rated on a 5-point Likert scale (0 = not at all; 4 = extremely). The total score ranges from 0 to 24, with a higher score reflecting greater anxiousness.

    Measured: Baseline and Three months

  3. Change in Vulnerable Elders Survey 13

    The Vulnerable Elders Survey 13 (VES-13) includes four dimensions: age, self-assessment of health, physical function, and living function. Each domain is scored differently. Age is scored as follows: 75-84 years = 1 point, ≥ 85 years = 3 points. Self-rated health is categorized into "fair and poor" or "good", "very good", or "excellent", with only the "fair and poor" category scoring 1 point. The total score ranges from 0 to 15, with higher scores indicating greater vulnerability.

    Measured: Baseline and Three months

  4. Change in Short-term Heart Rate Variability

    Short-term Heart Rate Variability (HRV) will be collected using the Polar H9 heart rate monitor (Polar Electro OY, Kempele, Finland). The investigator will send a reminder about the precautions to be taken (e.g., avoiding caffeine, alcohol, smoking, and intense physical activity, as these factors could affect the HRV measurement for successful HRV measurement the day before the scheduled test. The investigator will again ask if the instructions have been followed when they arrive for data collection.

    Study patients will be instructed to lay supine for 10 minutes without speaking and to remain as still as possible. The investigator will place the Polar H9 heart rate monitor on the center of the sternum to measure HRV. During HRV data collection, the study patients will also wear the ActiGraph on the waist because the Polar H9 communicates with the ActiGraph.

    Measured: Baseline and Three months

  5. Muscle Strength at Baseline

    Muscle strengths will be measured using the handheld dynamometry (HHD, Lafayette dynamometer, model01165APP; Lafayette Instrument Company, Lafayette, Ind., USA). This device measures the peak force exerted in kilograms for five seconds during muscle contraction on hips and quadriceps.

    Measured: Baseline

  6. Change in Balance

    Balance will be measured using an Inertial Measurement Unit device (DOTIMU; Xsens Technologies, Enschede., the Netherlands). The investigators attach the IMU sensor (a small device the size of a large watch face) to the participant's lower back at the level of L3 vertebra. Patients will be asked to take off their shoes and stand up on the mat with their hands on their hips for 30 seconds. The investigators will measure balance 3 times, with 30 seconds of rest between assessments. The total estimated time for the balance test is 3-5 minutes. All signal processing, subsequent feature extraction, and analysis will be performed using MATLAB version R2018B (The Mathworks Inc., Natick, MA, USA). The root-mean-square (RMS) value of the acceleration signal will be used to quantify the magnitude and trajectory of postural sway in each direction. The RMS of the magnitude vector of the 3-axis acceleration signal will be used as the summary score.

    Measured: Baseline and Three months

  7. Change in Physical Activity

    Physical activity (PA) will be measured using actigraphy, the gold-standard for measuring physical activity. The investigator will use the ActiGraph (GT3X Link model), a triaxial instrument, which is the most widely used wearable accelerometer in clinical research. All patients will be instructed to wear the device for nine consecutive days, including at least one weekend day. Both baseline and 3-month values were calculated in a similar way.

    Measured: Baseline and Three months

  8. Muscle Strength at 3 Months

    Muscle strengths will be measured using the handheld dynamometry (HHD, Lafayette dynamometer, model01165APP; Lafayette Instrument Company, Lafayette, Ind., USA). This device measures the peak force exerted in kilograms for five seconds during muscle contraction on hips and quadriceps.

    Measured: Three months

Timeline

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

  1. First posted1 Feb 2024
  2. Study start15 Nov 2023
  3. Primary completion26 Nov 2024
  4. Study completion26 Nov 2024

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
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06235658
Sponsor's protocol ID
86669
Status last verified
Feb 2026
First submitted
23 Jan 2024
Last updated
27 Feb 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Gentle Yoga in people with Cardiovascular Diseases in Old Age, run by Geunyeong Cha 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 5 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 27 Feb 2026. 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?

Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Recruitment Rate (time frame: Three months). The study lists 5 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 27 Feb 2026.

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