Yoga for Cognitive Impairment in Heart Failure

Overseen By Chin-Yen Lin, RN, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Auburn University

Disqualifiers: Neurological, Psychiatric, Terminal, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether yoga can improve brain function in people with heart failure and mild cognitive impairment. The study compares the effects of a 12-week yoga program to a control group that does not practice yoga. Participants must have heart failure, mild cognitive issues, and symptoms like shortness of breath or fatigue during regular activities. The trial aims to determine if yoga's gentle movements and breathing exercises can enhance mental clarity and quality of life. As an unphased trial, it offers a unique opportunity to explore yoga's potential benefits for mental and physical well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that yoga is safe for patients with heart failure and mild cognitive impairment?

Research has shown that yoga is a safe and beneficial activity for people with heart failure. One study on a specific yoga program found it not only safe but also effective in enhancing physical abilities such as strength and balance. Participants reported no major negative side effects.

Another study suggested that yoga may improve overall health and exercise capacity in heart failure patients, including better breathing and heart function, which are crucial for well-being.

Overall, heart failure patients generally tolerate yoga well. It offers a gentle and supportive way to enhance both physical and mental health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using yoga to address cognitive impairment in heart failure patients because it offers a non-pharmaceutical approach that could complement existing treatments like medication and cognitive behavioral therapy. Unlike traditional medications, yoga focuses on improving both mental and physical well-being through mindfulness, breathing exercises, and physical postures, which may enhance brain function and reduce stress. This holistic method could provide an accessible and low-cost option with minimal side effects, potentially benefiting patients who are unable or unwilling to use conventional medications.

What evidence suggests that yoga might be an effective treatment for cognitive impairment in heart failure?

Research has shown that yoga might improve thinking skills, particularly attention and memory, in individuals with mild memory problems. For patients with conditions like cancer, yoga has shown promise in enhancing both brain and heart health. In this trial, participants in the yoga intervention arm will practice yoga to assess its effects on cognitive impairment in heart failure patients. A study review found that people with heart failure who practiced yoga had better thinking skills than those who did not. While these findings are encouraging, the specific effects of yoga on heart failure patients with mild memory issues remain under investigation. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients with heart failure who also have mild cognitive impairment. It aims to explore if yoga can improve their cognitive function and overall quality of life.

Inclusion Criteria

I have heart failure and mild memory or thinking problems.

I am 55 years old or older.

My heart condition limits my physical activity.

Exclusion Criteria

Have any other implanted metals that interfere with the MRI magnetic field for patient safety

I cannot do yoga because of my physical condition or illness.

Co-existing neurological disorders, traumatic brain injury, psychiatric disorders, or terminal illnesses

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 60-minute yoga session twice per week for 12 weeks

12 weeks

24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Yoga

Trial Overview

The study tests a 12-week yoga program against a control condition to see if yoga benefits cognitive health in those with heart failure and mild cognitive issues.

How Is the Trial Designed?

Group I: Yoga intervention Experimental Treatment 1 Intervention

Group II: Control condition Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Auburn University

Lead Sponsor

Trials

81

Recruited

14,600+

VCOM, Auburn campus

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

A meta-analysis of two randomized controlled trials involving 30 patients practicing yoga and 29 control patients showed that yoga significantly improved exercise capacity (peak VO2) and health-related quality of life (HRQOL) in individuals with chronic heart failure (CHF).

The yoga group demonstrated a weighted mean difference of 3.87 in peak VO2 and a standardized mean difference of -12.46 in HRQOL compared to the control group, suggesting that yoga could be a beneficial addition to cardiac rehabilitation programs for CHF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Yoga in Patients with Chronic Heart Failure: A Meta-Analysis. Gomes-Neto, M., Rodrigues, ES., Silva, WM., et al.[2021]

A systematic review of 94 randomized controlled trials involving 8,430 participants found that yoga is as safe as usual care and exercise, with no significant differences in serious adverse events or dropouts due to adverse events.

While yoga had a higher occurrence of nonserious adverse events compared to psychological or educational interventions, the overall safety profile suggests that it is a viable therapeutic option, highlighting the need for better reporting of safety data in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cramer, H., Ward, L., Saper, R., et al.[2018]

The Tele-Yoga intervention was found to be acceptable and appropriate for individuals with heart failure and chronic obstructive pulmonary disease, with participants appreciating the home-based format and reporting enjoyment from the yoga sessions.

Despite some technological issues affecting video quality, the intervention showed potential benefits through physical postures, breathing exercises, and relaxation techniques, highlighting the need for further research to improve delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Appropriateness and acceptability of a Tele-Yoga intervention for people with heart failure and chronic obstructive pulmonary disease: qualitative findings from a controlled pilot study. Selman, L., McDermott, K., Donesky, D., et al.[2022]

Computerized Cognitive Training (CCT) significantly improved psychomotor and attention abilities in individuals with Mild Cognitive Impairment (pwMCI) compared to yoga, with a moderate effect size observed at 12 months post-intervention.

Continued practice of CCT at home further enhanced these cognitive benefits, while neither CCT nor yoga showed significant improvements in learning or working memory abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Training (CCT) versus Yoga Impact on 12 Month Post Intervention Cognitive Outcome in Individuals with Mild Cognitive Impairment. Phatak, VS., Smith, GE., Locke, D., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6541218/

The effects of yoga on patients with mild cognitive ...

Results suggest that yoga may have beneficial effects on cognitive functioning, particularly on attention and verbal memory.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9524232/

Impact of integrated yoga therapy on cognitive impairment ...

Practices such as yoga have shown promising results in improving cognitive (30) and cardiac functioning as studied in subjects with cancer (31).

3.

withpower.com

withpower.com/trial/phase-heart-failure-6-2024-defac

Yoga for Cognitive Impairment in Heart Failure

A meta-analysis of two randomized controlled trials involving 30 patients practicing yoga and 29 control patients showed that yoga significantly improved ...

4.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2799406

Effects of Mindfulness Training and Exercise on Cognitive ...

The findings do not support the use of mindfulness training, exercise, or a combination of both for significantly improving cognitive function in older adults.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352906718301763

Effectiveness of mindfulness-based stress reduction ...

The MBSR program led to a stable improvement of the scores of self-efficacy and quality of life of cardiovascular patients. Abstract. Introduction.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11145560/

Mindfulness-Based Interventions for Patients with ...

This meta-analysis review demonstrated that mindfulness-based interventions have favorable effects on psychological and physiological outcomes ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1071916410002034

Yoga in Heart Failure Patients: A Pilot Study

This study of a modified yoga program was safe, feasible, and demonstrated improvements in physical function (strength, balance, and endurance) and symptom ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00696852

Mindfulness, Yoga, and Cardiovascular Disease ...

The yoga and mindfulness classes will combine specific techniques of meditation, simple yoga postures, and breathing exercises. · Other Names: MBSR.

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10550367/

Yoga as Adjunct Therapy for Chronic Heart Failure

Current evidence suggests that yoga may be an effective complementary and integrative therapy for improving peak VO 2 exercise capacity, NT-proBNP, and quality ...