COPD AsthmaNCT05397275
The Effect of Progressive Relaxation and Breathing Exercise on Sleep Quality and Exercise Self-Efficacy in Patients With COPD
A study testing progressive muscle relaxation+breathe exercises and breathe exercises in people with COPD Asthma, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study was conducted to determine the effect of progressive muscle relaxation and breathing exercise on sleep quality and exercise self-efficacy in chronic obstructive pulmonary patients. Methods: This study was conducted as a randomized controlled experimental study. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COPD Asthma
- What is being tested?
- progressive muscle relaxation+breathe exercises and breathe exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 1 Oct 2021
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- were to be 18 years of age or older
- not using sleeping pills
- verbally stating that they have moderate and severe sleep disorders.
Who cannot join
- having any lung disease other than COPD
- having cardiological problems (heart failure, uncontrollable hypertension, history of angina and myocardial infarction, heart valve problems), psychotic disorder,
- inability to communicate verbally and having hearing problems.
Trial locations and contacts
1 site in 1 country.
About this study
Aim: This study was conducted to determine the effect of progressive muscle relaxation and breathing exercise on sleep quality and exercise self-efficacy in chronic obstructive pulmonary patients.
Methods: This study was conducted as a randomized controlled experimental study. The study was conducted with 64 chronic obstructive pulmonary patients, where 36 of them were in the intervention group and 34 in the control group. Data of the study were collected using the descriptive information form, the Pittsburgh Sleep Quality Index, and the Exercise Self-Regulatory Efficacy Scale (Ex-SRES) for patients with COPD.
Read more
Results: When the total scores pertaining to the sleep quality index and exercise self-efficacy of the individuals in the intervention and control groups were compared, it was found that there were statistically significant differences in the intervention group compared to the control group (p < 0.05).
Keywords: Exercise Self-Regulatory Efficacy, sleep quality in patients with COPD, PGE along with breathing exercises, pulmonary rehabilitation
- Conditions
- COPD Asthma
- Being tested
- progressive muscle relaxation+breathe exercises, breathe exercises
- Keywords
- Exercise Self-Regulatory Efficacy,, sleep quality, PGE with breathing exercises, pulmonary rehabilitation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive muscle relaxation+breathe exercisesOther
progressive muscle relaxation+breathe exercises
breathe exercisesOther
breathe exercises
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | progressive muscle relaxation exercises + breathing exercise Receives: Other: progressive muscle relaxation+breathe exercises |
| control group | Experimental | only breathing exercise Receives: Other: breathe exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
progressive muscle relaxation exercises changes sleep quality and exercise self-efficacy.
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index as an pre- test and 4 weeks later as a post-test test.
Measured: 1 mounth
Secondary outcomes (1)
progressive muscle relaxation exercises with breathing exercise changes sleep quality and exercise self-efficacy.
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index as an pre-test and 4 weeks later as a post-test.
.The Exercise Self-Regulatory Efficacy Scale will be used as a pre-test and after 4 weeks as a post-test to measure the exercise capacity of COPD patients.
Measured: 1 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Feb 2021
- Primary completion1 Jul 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD AsthmaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevser Sevgi Ünal Aslan, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397275
- Sponsor's protocol ID
- osmaniye korkut ata university
- Status last verified
- May 2022
- First submitted
- 20 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: may be published at the discretion of the authors, provided appropriate justifications are provided.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation and Breathing Exercise on Sleep Quality and Exercise Self-Efficacy in Patients With COPD
- ClinicalTrials.gov ID
- NCT05397275
- Acronym / sponsor ID
- osmaniye korkut ata university
- Conditions
- COPD Asthma
- Keywords
- Exercise Self-Regulatory Efficacy,, sleep quality, PGE with breathing exercises, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 31 May 2022 (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.
Aim: This study was conducted to determine the effect of progressive muscle relaxation and breathing exercise on sleep quality and exercise self-efficacy in chronic obstructive pulmonary patients.
Methods: This study was conducted as a randomized controlled experimental study. The study was conducted with 64 chronic obstructive pulmonary patients, where 36 of them were in the intervention group and 34 in the control group. Data of the study were collected using the descriptive information form, the Pittsburgh Sleep Quality Index, and the Exercise Self-Regulatory Efficacy Scale (Ex-SRES) for patients with COPD.
Results: When the total scores pertaining to the sleep quality index and exercise self-efficacy of the individuals in the intervention and control groups were compared, it was found that there were statistically significant differences in the intervention group compared to the control group (p < 0.05).
Keywords: Exercise Self-Regulatory Efficacy, sleep quality in patients with COPD, PGE along with breathing exercises, pulmonary rehabilitation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: progressive muscle relaxation+breathe exercisesprogressive muscle relaxation exercises + breathing exercise |
| control group | Experimental | Other: breathe exercisesonly breathing exercise |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- were to be 18 years of age or older
- not using sleeping pills
- verbally stating that they have moderate and severe sleep disorders.
Key exclusion criteria (3 listed)
- having any lung disease other than COPD
- having cardiological problems (heart failure, uncontrollable hypertension, history of angina and myocardial infarction, heart valve problems), psychotic disorder,
- inability to communicate verbally and having hearing problems.
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 |
|---|---|---|
| progressive muscle relaxation+breathe exercisesprogressive muscle relaxation+breathe exercises | Other | experimental group |
| breathe exercisesbreathe exercises | Other | control group |
Primary outcome
progressive muscle relaxation exercises changes sleep quality and exercise self-efficacy.
Time frame: 1 mounth
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index as an pre- test and 4 weeks later as a post-test test.
1 secondary outcome
progressive muscle relaxation exercises with breathing exercise changes sleep quality and exercise self-efficacy.
Time frame: 1 mounth
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 31 May 2022.
- Individual participant dataSharing planned: Undecided. may be published at the discretion of the authors, provided appropriate justifications are provided.
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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?
A study testing progressive muscle relaxation+breathe exercises and breathe exercises in people with COPD Asthma, run by Osmaniye Korkut Ata University 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 3 inclusion and 3 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 31 May 2022. 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?
progressive muscle relaxation exercises changes sleep quality and exercise self-efficacy. (time frame: 1 mounth). 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 31 May 2022.