NCT05905627

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 6, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2023

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

5 days

First QC Date

June 6, 2023

Last Update Submit

June 21, 2023

Conditions

Keywords

heart failure, breathing exercise, relaxation exercise

Outcome Measures

Primary Outcomes (1)

  • The effect of ephesus exercise on the mean fatigue score

    The effect of ephesus exercise on the mean fatigue score

    3 months

Study Arms (3)

breathing exercise group

breathing exercise group

Behavioral: exercise

relaxation exercise group

relaxation exercise group

Behavioral: exercise

control group

control group

Interventions

exerciseBEHAVIORAL

intervention group

Also known as: breathing and relaxation exercise
breathing exercise grouprelaxation exercise group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yalova University

Yalova, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure

Interventions

ExerciseRespiration

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 6, 2023

First Posted

June 15, 2023

Study Start

June 6, 2023

Primary Completion

June 11, 2023

Study Completion

June 21, 2023

Last Updated

June 23, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

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.

Locations