Yoga in Older Cardiac Patients

NCT06235658 | Completed Results

• 1 other identifier: 86669
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Physical Activity; Yoga; Mind-body therapies

Outcome Measures

Primary Outcomes (5)

• 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.

  Three months

Secondary Outcomes (8)

• Change in Patient Health Questionnaire-9

  Baseline and Three months

• Change in Brief Symptom Inventory

  Baseline and Three months

• Change in Vulnerable Elders Survey 13

  Baseline and Three months

• Change in Short-term Heart Rate Variability

  Baseline and Three months

• Muscle Strength at Baseline

  Baseline

Study Arms (2)

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.

Behavioral: Gentle Yoga

Interventions

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.

Online Yoga Intervention

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Geunyeong Cha: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40526, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

The measures of anxiety (Brief Symptom Index) and intervention acceptability although reported here have reliability issues.

Results Point of Contact

• Title: Dr. Geunyeong Cha
• Organization: University of Tennessee

drivek67@gmail.com

8596290657

Study Officials

• Debra K Moser, Ph.D

  University of Kentucky

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 1, 2024
• Study Start: November 15, 2023
• Primary Completion: November 26, 2024
• Study Completion: November 26, 2024
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)