An interventional study of Slow breathing techniques in Congestive Heart Failure, sponsored by Vanderbilt University Medical Center. Withdrawn. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-04.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
Slow breathing may reduce stress. Adults with congestive heart failure have higher stress than the general population. This study will examine if using slow breathing is feasible among adults with heart failure.
Exclusion Criteria:
Slow breathing techniques with exhale greater than inhale
Behavioral: Slow breathing techniques
8 sessions of instruction in slow breathing exercises over 12 weeks of study
Feasibility of intervention administration measured by frequency of visits
Investigators will document weekly attendance
Time frame: Weekly for 12 weeks
Feasibility of intervention administration measured by home practice adherence
Investigators will ask participants how often they practiced yoga at home since last session
Time frame: Weekly for 12 weeks
Feasibility of intervention administration measured by patient satisfaction
A survey will be administered that assesses participant satisfaction with the yoga. Overall satisfaction will be assessed by "Very Unsatisfied", "Unsatisfied", "Satisfied", "Very Satisfied".
Time frame: One time, at 12 week survey
Safety of yoga practice as measured by occurrence of adverse events
Investigators will monitor for adverse events related to yoga practice during the intervention and will solicit any adverse events during home practice since last meeting.
Time frame: Weekly for 12 weeks
Magnitude of change in PROMIS Depression scale
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Computer Adaptive Test (CAT). The PROMIS Depression instruments assess self-reported negative mood (sadness, guilt), views of self (selfcriticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). With CAT, participant responses guide the system's choice of subsequent items from the full item bank (28 items in total) and a T-Score is generated. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A higher score reflects higher levels of depression.
Time frame: Baseline, 6 week, 12 week
Magnitude of change in PROMIS Anxiety scale
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computer Adaptive Test (CAT). The PROMIS Anxiety instruments measure self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). With CAT, participant responses guide the system's choice of subsequent items from the full item bank (29 items in total) and a T-Score is generated. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A higher score reflects higher levels of anxiety.
Time frame: Baseline, 6 week, 12 week
Magnitude of change in PROMIS Global Health scale
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health. The PROMIS Global Health measures assess an individual's physical, mental, and social health. Each of the 10 items are totaled into a raw sum score and Raw Sum Scores are then converted into T-Scores. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A higher score reflects higher levels of physical, mental, and social health.
Time frame: Baseline, 6 week, 12 week
Magnitude of change in PROMIS Physical Function scale
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (CAT). PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living, such as running errands. With CAT, participant responses guide the system's choice of subsequent items from the full item bank (165 items in total) and a T-Score is generated. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A higher score reflects higher levels of physical functioning.
Time frame: Baseline, 6 week, 12 week
Magnitude of change in PROMIS Fatigue scale
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Computer Adaptive Test (CAT). The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. With CAT, participant responses guide the system's choice of subsequent items from the full item bank (95 items in total) and a T-Score is generated. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A higher score reflects higher levels of fatigue.
Time frame: Baseline, 6 week, 12 week
Magnitude of change in PROMIS Dyspnea scale
Patient-Reported Outcomes Measurement Information System (PROMIS) Dyspnea Severity Computer Adaptive Test (CAT). The PROMIS Dyspnea instruments evaluate a range of self-reported symptoms related to dyspnea. With CAT, participant responses guide the system's choice of subsequent items from the full item bank (33 items in total) and a T-Score is generated. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A higher score reflects higher levels of dyspnea.
Time frame: Baseline, 6 week, 12 week
Autonomic tone
The investigators will estimate autonomic tone of participants by extracting data from implantable cardioverter defibrillator (ICD). Data analyses will consist of heart rate spectral analyses.
Time frame: Monthly data extraction from ICD: Baseline, week 4, week 8, week 12
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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Vanderbilt University Medical Center