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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gentle Yoga | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra K Moser, Ph.D | University of Kentucky | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40526 | United States |
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A total of 41 individuals were recruited. Of these, 36 provided informed consent and were formally enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | 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. |
| FG001 | Online Yoga Intervention | Participants in the intervention group will attend two virtual 60-minute gentle yoga sessions per week for 12 weeks. Gentle Yoga: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline measures are only reported for study participants who completed all of baseline and 3-month assessments
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 287 is the number of participants approached to join the study. The number of participants enrolled (n = 36). Number of eligible patients approached (n = 287). | Posted | Count of Participants | Participants | Three months |
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12-weeks
During and after the yoga classes, both the yoga instructor and the PI monitored participants for symptoms and stopped the yoga session to question any participant who appeared to be having symptoms or who reported having symptoms. No all-cause mortality, serious adverse events, or other adverse events were observed in either group during the 12-week intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | 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. |
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The measures of anxiety (Brief Symptom Index) and intervention acceptability although reported here have reliability issues.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Geunyeong Cha | University of Tennessee | 8596290657 | drivek67@gmail.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Aug 6, 2024 | Sep 8, 2025 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Three months |
| Online Yoga Intervention |
Participants in the intervention group will attend two virtual 60-minute gentle yoga sessions per week for 12 weeks. Gentle Yoga: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Three months |
|
|
|
| Primary | 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. | This measure was only taken by the intervention group | Posted | Number | percentage of sessions | Three months | sessions | sessions |
|
|
|
| Primary | 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. | Only participants in the intervention arm completed this satisfaction survey. One out of 16 participants did not respond to this survey and was excluded, leaving 15 participants for analysis. | Posted | Mean | Standard Deviation | score on a scale | Three months |
|
|
|
| Primary | 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. | Only participants in the intervention arm completed this satisfaction survey. | Posted | Mean | Standard Deviation | score on a scale | Three months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Three months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Three months |
|
|
|
| Secondary | 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. | Although baseline data were collected, it was pre-specified to report a change value at month 3. No data were collected at month 3 for participants because the use of the survey was abandoned and therefore data were not collected for the Outcome Measure | Posted | Baseline and Three months |
|
|
| Secondary | 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. | Although some baseline data were collected, it was pre-specified to report a change value at month 3. No participants were assessed at month 3 and therefore the pre-specified change value cannot be calculated. Data not collected. | Posted | Number | units on a scale | Baseline and Three months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | peak force (kgf) | Baseline |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | meters per second squared | Baseline and Three months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | minutes per day | Baseline and Three months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | peak force (kgf) | Three months |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Online Yoga Intervention | Participants in the intervention group will attend two virtual 60-minute gentle yoga sessions per week for 12 weeks. Gentle Yoga: 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. | 0 | 16 | 0 | 16 | 0 | 16 |
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| Quadricep, Right, Baseline |
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| Quadricep, Left, Baseline |
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| Quadricep, Right, 3-month |
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| Quadricep, Left, 3-month |
|