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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

Mild cognitive impairment is highly prevalent in patients with heart failure and results in poor well-being and quality of life. While yoga has proven effective in promoting cognitive health in older adults through its gentle movements, controlled breathing, and meditation, its effects on patients with heart failure remain unknown. Therefore, this feasibility and pilot study plans to deliver a 12-week yoga intervention and test its effects on cognitive function in patients with heart failure and mild cognitive impairment.

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 data supports the effectiveness of this treatment for cognitive impairment in heart failure?

Research suggests that yoga can improve exercise capacity and quality of life in heart failure patients, which may indirectly support its potential benefits for cognitive function. Yoga's combination of physical and breathing exercises has shown positive effects on physical and psychological health, which could be beneficial for cognitive impairment. ^{1 2 3 4 5}

Is yoga safe for people with heart failure?

Yoga is generally considered safe for people with heart failure, as studies have not reported any serious adverse events related to its practice. However, some nonserious adverse events have been noted, similar to those seen with other physical or educational interventions. ^{1 2 4 6 7}

How is yoga treatment different for cognitive impairment in heart failure?

Yoga is unique because it combines physical and breathing exercises, which may improve exercise capacity, reduce inflammation, and enhance quality of life in heart failure patients, unlike standard drug treatments that primarily focus on managing symptoms and heart function. ^{1 2 4 5 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Yoga in heart failure patients: a pilot study. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of yoga on inflammation and exercise capacity in patients with chronic heart failure. [2023]

3. Brazil pubmed.ncbi.nlm.nih.gov

Effects of Yoga in Patients with Chronic Heart Failure: A Meta-Analysis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Benefits of yoga for African American heart failure patients. [2023]

5. England 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. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Yoga as Adjunct Therapy for Chronic Heart Failure: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]

8. Switzerland 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. [2021]