Study for Breathing Interventions in Congestive Heart Failure

NCT03449121 | Withdrawn DMC

• 1 other identifier: 171991
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Congestive Heart Failure

Keywords

Breathing; Mind-body

Outcome Measures

Primary Outcomes (4)

• Feasibility of intervention administration measured by frequency of visits

  Investigators will document weekly attendance

  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

  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".

  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.

  Weekly for 12 weeks

Secondary Outcomes (7)

• Magnitude of change in PROMIS Depression scale

  Baseline, 6 week, 12 week

• Magnitude of change in PROMIS Anxiety scale

  Baseline, 6 week, 12 week

• Magnitude of change in PROMIS Global Health scale

  Baseline, 6 week, 12 week

• Magnitude of change in PROMIS Physical Function scale

  Baseline, 6 week, 12 week

• Magnitude of change in PROMIS Fatigue scale

  Baseline, 6 week, 12 week

Study Arms (1)

Slow breathing

EXPERIMENTAL

Slow breathing techniques with exhale greater than inhale

Behavioral: Slow breathing techniques

Interventions

Slow breathing techniques BEHAVIORAL

8 sessions of instruction in slow breathing exercises over 12 weeks of study

Slow breathing

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

MeSH Terms

Conditions

Heart Failure; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 28, 2018
• Study Start: November 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: March 4, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share