Clinical trial NCT05905627: Breathing Relaxation Exercise Heart Failure
Official title: The Effect of Breathing and Relaxation Exercise on Dyspnea, Fatigue and Self-Care Level
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Keywords: heart failure, breathing exercise, relaxation exercise
Lead sponsor: University of Yalova
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The effect of ephesus exercise on the mean fatigue score
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Yalova
country: Turkey
facility: Yalova University
Study officials:
References: