Back to resultsStudy for Breathing Interventions in Congestive Heart Failure
Primary Purpose
Congestive Heart Failure
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Slow breathing techniques
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Breathing, Mind-body
Eligibility Criteria
Inclusion Criteria:
- Documented heart failure from medical chart review with signs and symptoms consistent with disease
- Reduced left ventricular function with ejection fraction of less than or equal to 40%
- English speaking
Exclusion Criteria:
- New York Heart Failure Association Class I or IV
- Myocardial infarction in the last 3 months
- Cardiac surgery in the last 3 months
- Significant valvular heart disease
- Uncontrolled cardiac arrhythmias
- Uncontrolled diabetes mellitus (hemoglobin a1c ≥ 8)
- Uncontrolled hypertension
- Systolic greater than 140 mmHg
- Diastolic greater than or 90 mmHg
- Cognitive impairment (Mini-mental state exam less than or equal to 24)
- Acute major depression in the last 3 months
- Other psychiatric conditions including schizophrenia or bipolar disorder
- Attention-deficit-disorder or attention-deficit-hyperactivity disorder
- Musculoskeletal condition limiting capacity to perform simple movements such as significant chronic lower back pain or neck pain
- Unstable or severe chronic lung conditions
- Current participation in a mind-body practice/program
- Current cancer other than non-melanoma skin cancer
- Regular swimmer
- Plays wind or brass musical instruments
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Slow breathing
Arm Description
Slow breathing techniques with exhale greater than inhale
Outcomes
Primary Outcome Measures
Feasibility of intervention administration measured by frequency of visits
Investigators will document weekly attendance
Feasibility of intervention administration measured by home practice adherence
Investigators will ask participants how often they practiced yoga at home since last session
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".
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03449121
First Posted
January 31, 2018
Last Updated
February 28, 2019
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03449121
Brief Title
Study for Breathing Interventions in Congestive Heart Failure
Official Title
Pilot Study for Breathing Interventions in Congestive Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Why Stopped
PI left VUMC
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Breathing, Mind-body
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Slow breathing
Arm Type
Experimental
Arm Description
Slow breathing techniques with exhale greater than inhale
Intervention Type
Behavioral
Intervention Name(s)
Slow breathing techniques
Intervention Description
8 sessions of instruction in slow breathing exercises over 12 weeks of study
Primary Outcome Measure Information:
Title
Feasibility of intervention administration measured by frequency of visits
Description
Investigators will document weekly attendance
Time Frame
Weekly for 12 weeks
Title
Feasibility of intervention administration measured by home practice adherence
Description
Investigators will ask participants how often they practiced yoga at home since last session
Time Frame
Weekly for 12 weeks
Title
Feasibility of intervention administration measured by patient satisfaction
Description
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
Title
Safety of yoga practice as measured by occurrence of adverse events
Description
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
Secondary Outcome Measure Information:
Title
Magnitude of change in PROMIS Depression scale
Description
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
Title
Magnitude of change in PROMIS Anxiety scale
Description
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
Title
Magnitude of change in PROMIS Global Health scale
Description
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
Title
Magnitude of change in PROMIS Physical Function scale
Description
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
Title
Magnitude of change in PROMIS Fatigue scale
Description
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
Title
Magnitude of change in PROMIS Dyspnea scale
Description
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
Title
Autonomic tone
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented heart failure from medical chart review with signs and symptoms consistent with disease
Reduced left ventricular function with ejection fraction of less than or equal to 40%
English speaking
Exclusion Criteria:
New York Heart Failure Association Class I or IV
Myocardial infarction in the last 3 months
Cardiac surgery in the last 3 months
Significant valvular heart disease
Uncontrolled cardiac arrhythmias
Uncontrolled diabetes mellitus (hemoglobin a1c ≥ 8)
Uncontrolled hypertension
Systolic greater than 140 mmHg
Diastolic greater than or 90 mmHg
Cognitive impairment (Mini-mental state exam less than or equal to 24)
Acute major depression in the last 3 months
Other psychiatric conditions including schizophrenia or bipolar disorder
Attention-deficit-disorder or attention-deficit-hyperactivity disorder
Musculoskeletal condition limiting capacity to perform simple movements such as significant chronic lower back pain or neck pain
Unstable or severe chronic lung conditions
Current participation in a mind-body practice/program
Current cancer other than non-melanoma skin cancer
Regular swimmer
Plays wind or brass musical instruments
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study for Breathing Interventions in Congestive Heart Failure
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