Congestive Heart FailureNCT05905627
Breathing Relaxation Exercise Heart Failure
An observational study of Congestive Heart Failure, run by University of Yalova at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2023to 21 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Congestive Heart Failure
- Being tested
- exercise
- Keywords
- heart failure, breathing exercise, relaxation exercise
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
Also called breathing and relaxation exercise
intervention group
| Study group | Role | What they receive |
|---|---|---|
| breathing exercise group | breathing exercise group Receives: Behavioral: exercise | |
| relaxation exercise group | relaxation exercise group Receives: Behavioral: exercise | |
| control group | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of ephesus exercise on the mean fatigue score
The effect of ephesus exercise on the mean fatigue score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start6 Jun 2023
- Primary completion11 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gürcan Solmaz, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905627
- Sponsor's protocol ID
- gurcan
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breathing and Relaxation Exercise on Dyspnea, Fatigue and Self-Care Level
- ClinicalTrials.gov ID
- NCT05905627
- Acronym / sponsor ID
- gurcan
- Conditions
- Congestive Heart Failure
- Keywords
- heart failure, breathing exercise, relaxation exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 11 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| breathing exercise group | – | Behavioral: exercisebreathing exercise group |
| relaxation exercise group | – | Behavioral: exerciserelaxation exercise group |
| control group | – | –control group |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseAlso: breathing and relaxation exerciseintervention group | Behavioural | breathing exercise group, relaxation exercise group |
Primary outcome
The effect of ephesus exercise on the mean fatigue score
Time frame: 3 months
The effect of ephesus exercise on the mean fatigue score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by University of Yalova at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of ephesus exercise on the mean fatigue score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.