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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Cardiovascular Diseases in Old Age
- 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 group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants 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 Intervention | Experimental | Participants 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.
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
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
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
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
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)
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
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
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
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
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
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
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
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.
- First posted1 Feb 2024
- Study start15 Nov 2023
- Primary completion26 Nov 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular Diseases in Old AgeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geunyeong Cha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Geunyeong Cha, University of Kentucky
- Investigators
- Debra K Moser, Ph.D, Study chair, University of Kentucky
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yoga on Physical and Psychological Outcomes in Older Patients Discharged From Cardiac Rehabilitation: A Pilot Study
- ClinicalTrials.gov ID
- NCT06235658
- Acronym / sponsor ID
- 86669
- Conditions
- Cardiovascular Diseases in Old Age
- Keywords
- Physical Activity, Yoga, Mind-body therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Geunyeong ChaUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Posted 27 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants 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 Intervention | Experimental | Behavioral: Gentle YogaParticipants in the intervention group will attend two virtual 60-minute gentle yoga sessions per week for 12 weeks. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Gentle YogaParticipants 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. | Behavioural | Online Yoga Intervention |
Primary outcome
Recruitment Rate
Time frame: Three months
The recruitment rate (%) will be calculated by dividing the total number of patients enrolled by approached eligible patients and then multiplying it by 100.
Number of Participants Who Completed the Study
Time frame: Three months
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.
Intervention Adherence Rate
Time frame: Three months
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.
Intervention Acceptability
Time frame: Three months
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.
Intervention Satisfaction
Time frame: Three months
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.
8 secondary outcomes
Change in Patient Health Questionnaire-9
Time frame: Baseline and Three months
Change in Brief Symptom Inventory
Time frame: Baseline and Three months
Change in Vulnerable Elders Survey 13
Time frame: Baseline and Three months
Change in Short-term Heart Rate Variability
Time frame: Baseline and Three months
Muscle Strength at Baseline
Time frame: Baseline
Change in Balance
Time frame: Baseline and Three months
Change in Physical Activity
Time frame: Baseline and Three months
Muscle Strength at 3 Months
Time frame: Three months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Debra K Moser, Ph.D study chair
University of Kentucky
1 site in 1 country: see every site and its status.
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.