Heart Failure Clinical Trial
Official title:
Mindfulness-Based Stress Reduction as an Adjunct Intervention to Cardiac Rehabilitation: A Pilot Study
NCT number | NCT02722213 |
Other study ID # | 1603M85502 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | August 2017 |
Verified date | October 2019 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The guideline-recommended standard of care for patients who have experienced a heart attack, heart failure, or other coronary event or procedure is exercise-based cardiac rehabilitation (CR). Despite proven benefits, traditional CR is severely underutilized. Moreover, what is typically lacking from traditional CR programs is effective psychosocial risk management. This represents a critical gap in care given the well-documented psychosocial needs of this patient population.The objective of this feasibility study is to conduct a pilot randomized controlled trial (RCT) of Mindfulness-Based Stress Reduction (MBSR) versus usual care in CR-eligible cardiac patients. Randomization will be stratified within two strata based on participation in CR (yes/no) among CR-eligible patients. The primary goals of this pilot study are to: 1) obtain estimates of treatment effects and variability; 2) evaluate recruitment and retention strategies; and 3) examine the safety of the MBSR protocol in CR-eligible patients.
Status | Completed |
Enrollment | 47 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - Men and women age 21 and older that are medically eligible and been referred for traditional exercise-based CR (heart attack within the past 12 months, open heart surgery such as coronary bypass/valve/heart transplant, coronary angioplasty or stent placement, current stable angina, or heart failure) - Willing to participate in all assessments and be randomized to either study condition - Able to give informed consent. Exclusion Criteria: - Has a cardiac pacemaker and is pacemaker-dependent or has an untreated atrial arrhythmia; - Previously completed an MBSR course; - Unable to read and write in English |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota Medical Center | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota | Fairview Health Services |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change (improvement) in heart rate variability (HRV). | Time domain and frequency domain variables will be assessed via 24-hour Holter monitoring at baseline, 3-month follow-up and 9-month follow-up. HRV is a well-established method to assess the autonomic nervous system, and has been shown to be a predictor of hard outcomes in cardiac patients. Given the deranged autonomic milieu in these patients, HRV is an appropriate surrogate end point for improved outcomes in this cohort. | 0-9 months | |
Secondary | Psychosocial function | Depressive symptoms, anxiety, stress, and health-related quality of life measures will be used to assess psychosocial function at baseline and changes in psychosocial function over the course of the study. | 0-9 months | |
Secondary | Cardiovascular risk factors: C-reactive protein (CRP), lipids, hemoglobin A1c (HgA1c) | Measures of lipids, inflammation (CRP) and glucose metabolism (HgA1c) will be obtained at 3 time points (baseline; 3-month follow-up; 9-month follow-up) to determine changes over the course of the study in these important cardiovascular risk factors. | 0-9 months | |
Secondary | Physical functioning | The Short Physical Performance Battery (SPPB) will be administered at baseline, 3-month follow-up and 9-month follow-up and will allow study investigators to evaluate changes in participants' physical function over time. | 0-9 months |
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