Breathing Relaxation Exercise Heart Failure

June 21, 2023 updated by: Gürcan Solmaz, University of Yalova

The Effect of Breathing and Relaxation Exercise on Dyspnea, Fatigue and Self-Care Level

The aim of the study is to determine the effect of breathing and relaxation exercises on dyspnea, fatigue and self-care level in heart failure patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Effect of Breathing and Relaxation Exercise on Dyspnea, Fatigue and Self-Care Level in Patients with Heart Failure: A Randomized Controlled Study It was planned according to CONSORT rules as a randomized controlled study to determine its effect on self-care level.

The hypotheses of the research are as follows:

a: Breathing exercise applied to HF patients has an effect on the mean dyspnea score. b: Breathing exercise applied to HF patients has an effect on the mean fatigue score. c: Breathing exercise applied to HF patients has an effect on self-care mean scores. d: Relaxation exercise applied to HF patients has an effect on the mean dyspnea score. e: Relaxation exercise applied to HF patients has an effect on the mean fatigue score.

f: Relaxation exercise applied to HF patients has an effect on self-care mean scores.

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Yalova, Turkey
        • Yalova University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The universe of the research; all heart failure patients. In order to determine the sample of the study, a similar study Lopes et al. (2018) considering the data obtained from the study, power=0.80, α=0.05 and β=0.20 were calculated. It was determined that 80% power could be reached if the study was conducted with at least 20 individuals in each group, at a significance level of p<0.05, with a medium effect size (ES: 0.5) in independent groups, with a 95% confidence interval. As a result of the calculation, taking into account the problems that may arise during the study process, it is planned to sample a total of 75 patients, 25 patients in each group (intervention group (yoga breathing and progressive relaxation exercise group) and control group).

Description

Inclusion Criteria:

(a) 18 years of age or older; (b) Patients with HF stage NYHA II-III; (c) hospitalized for two weeks; (d) Not pregnant; (e) Not applying any integrated treatment; (f) Patients who have been taking the same heart failure medication for at least three months.

Exclusion Criteria:

The exclusion criteria of patients are as follows: (a) Not expected to participate in a breathing or progressive relaxation exercise study in expert opinion; (b) Patients with COPD, (d) Patients with severe mental disorders.

Individuals' eligibility for inclusion and exclusion criteria will be evaluated through patient file records and interviews with the physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
breathing exercise group
Behavioral: exercise
intervention group
Other Names:
  • breathing and relaxation exercise
relaxation exercise group
Behavioral: exercise
intervention group
Other Names:
  • breathing and relaxation exercise
control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of ephesus exercise on the mean fatigue score
Time Frame: 3 months
The effect of ephesus exercise on the mean fatigue score
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Yalova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2023

Primary Completion (Actual)

June 11, 2023

Study Completion (Actual)

June 21, 2023

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gurcan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is planned to collect data between May and July 2023. Initially, patients' compliance with the inclusion and exclusion criteria will be determined through patient file records and interviews with the physician, and randomization will be performed. The research will be carried out in the hospital with the patients whose sample group is determined. In the first interview at the hospital, BPF, Borg Dyspnea Scale, Piper Fatigue and Self-Care Scale will be evaluated by the researcher through face-to-face interviews with the patients.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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