Diaphragmatic Breathing Retraining in Heart Failure Patients: Health-Behavior Related Outcomes

NCT01478932 | Terminated DMC

• 2 other identifiers: 0541-11-EP5P20NR011404-03
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to provide information on how the practicing of diaphragmatic breathing retraining (DBR) for 8-week at home may improve the health outcomes and encourage heart failure patients to engage in health-promoting activities by successfully controlling their shortness of breath (dyspnea).

Conditions

Dyspnea

Keywords

dyspnea; diaphragmatic breathing; Heart failure

Outcome Measures

Primary Outcomes (2)

• Dyspnea

  Dyspnea rating scale of 0 to 4 (0 = none to 4 = extraordinary)

  day 1, after 8-week intervention, after 5 months

• Fatigue

  Patient Reported Outcomes Measurement Information System (PROMIS-57) Profile fatigue scale of 0 to 5 (0 = not at all to 5 = very much)

  day 1, after 8-week intervention, after 5 months

Secondary Outcomes (7)

• Muscle Strength

  day 1, after 8-week intervention, after 5 months

• Physical activity

  day 1, after 8-week intervention, after 5 months

• Functional Status (6 minute walk test)

  day 1, after 8-week intervention, after 5 months

• Functional Status (Timed Get Up & Go)

  day 1, after 8-week intervention, after 5 months

• Depression Inventory

  day 1, after 8-week intervention, after 5 months

Study Arms (2)

Diaphragmatic Breathing Retraining

EXPERIMENTAL

In-person and written instructions will be given as to how to carry out the breathing retraining at home. Four telephone calls will be made from a member of the research team during the 8-week intervention at weeks 1, 2, 4, and 6. During the phone calls, progress and difficulties related to the breathing intervention will be discussed. A daily log to track performance of the intervention will be kept.

Behavioral: diaphragmatic breathing retraining

Health Promotion

PLACEBO COMPARATOR

In-person instructions will be given about what the intervention includes. Four telephone calls will be made from a member of the research team during the 8-week intervention at weeks 1, 2, 4, and 6. During the phone calls, health promotion topics will be discussed (lipid profile, healthy eating to improve lipid profile, importance of regular doctor visits, cancer screening, and so forth).

Behavioral: Health Promotion

Interventions

diaphragmatic breathing retraining BEHAVIORAL

In-person and written instructions will be given as to how to carry out the breathing retraining at home. Four telephone calls will be made from a member of the research team during the 8-week intervention at weeks 1, 2, 4, and 6. During the phone calls, progress and difficulties related to the breathing intervention will be discussed. A daily log to track performance of the intervention will be kept.

Diaphragmatic Breathing Retraining

Health Promotion BEHAVIORAL

n-person instructions will be given about what the intervention includes. Four telephone calls will be made from a member of the research team during the 8-week intervention at weeks 1, 2, 4, and 6. During the phone calls, health promotion topics will be discussed (lipid profile, healthy eating to improve lipid profile, importance of regular doctor visits, cancer screening, and so forth).

Health Promotion

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults age 19 or older
• diagnosed with chronic heart failure
• experiencing shortness of breath at rest or with activities
• experiencing shortness of breath that limits their activity
• cognitively intact indicated by being able to describe what participation in the study will involve
• have a telephone; AND
• reside in a rural area either large rural (10,000-49,000 residents), small rural (2500- 9999 residents), or isolated (\< 2499 residents) area

You may not qualify if:

• myocardial infarction or coronary bypass surgery within the last three months
• active chest pain
• uncontrolled arrhythmias (atrial fibrillation or ventricular tachycardia)
• on the transplant list or having a ventricular assist device
• orthopedic or neurological conditions that would impact muscle strength or interfere with the 6- minute walk test (6-MWT) (amputation, severe arthritis, Parkinson's, stroke, or severe neuropathy)
• history of severe chronic obstructive pulmonary disease (COPD); AND
• history of sleep breathing disorder

Sponsors & Collaborators

• University of Nebraska: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Dyspnea; Heart Failure

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Yaewon Seo, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

• Bernice Yates, PhD

  University of Nebraska

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 4, 2011
• First Posted: November 23, 2011
• Study Start: November 9, 2011
• Primary Completion: October 15, 2018
• Study Completion: October 15, 2018
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

US (1)