CopdNCT06459882
Effect of Progressive Relaxation Exercıses on Dyspnea and Comfort Level in Individuals With COPD
A study testing progressive relaxation exercises in people with Copd and Dyspnea, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
The study is a randomised controlled experimental study conducted to examine the effect of progressive relaxation exercises on dyspnea and comfort level in individuals with chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copd, Dyspnea, Nursing Caries
- What is being tested?
- progressive relaxation exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 30 Aug 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and over
- Inpatient treatment in the Internal Medicine Clinic of Izmir Urla State Hospital
- Standardised Mini Mental Test score ≥24
- Dyspnea severity ≥2 according to the MMRC dyspnoea scale
- Diagnosed with Stage II and Stage III COPD according to GOLD criteria
- Functional competence to participate in progressive relaxation exercises
- Able to access and use a smartphone
- COPD patients who agreed to participate in the study.
Who cannot join
- Have any speech and hearing problems
- Lung disease other than COPD, physical dependence and psychiatric illness diagnosed with
- COPD patients in the acute exacerbation period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Progressive Relaxation Exercises on Dyspnea and Comfort Level in Individuals With Chronıc Obstructive Lung Disease: A Randomized Controlled Study
The study is a randomised controlled experimental study conducted to examine the effect of progressive relaxation exercises on dyspnea and comfort level in individuals with chronic obstructive pulmonary disease. The study was conducted between January and August 2023 in the Internal Medicine Clinic of Izmir Urla State Hospital. Stratified and block randomisation method was used in the study and 42 patients, 21 intervention group and 21 control group, were completed. Patients in the intervention group received 30-minute progressive relaxation exercises for 6 weeks. Patients in the control group did not receive any intervention other than standard care practices. The data of the study were collected by face-to-face interview method using the Descriptive Information Form, Medical Research Council Dyspnea Scale, General Comfort Scale-Short Form and Patient Follow-up Form. Descriptive statistics, Shapiro Wilk test, Levene's test, Mauchly's W test, independent sample T test, Mann Whitney U test, dependent sample t test, Wilcoxon Signed Ranks test, Friedman test, Benferoni test and Fisher's Exact test were used to analyse the data obtained from the study. It was determined that the mean dyspnea level scores of the patients in the intervention group at week 6 were lower than the control group and this difference between the groups was statistically significant (p<0.05). It was determined that the decrease in the mean comfort level scores of the patients in the intervention group according to the follow-up periods was statistically significant (p<0.05). According to the results of the study, progressive relaxation exercises can be recommended as an effective nursing intervention to provide dyspnea management in patients with COPD.
- Conditions
- Copd, Dyspnea, Nursing Caries
- Being tested
- progressive relaxation exercises
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive relaxation exercisesBehavioural
Patients in the intervention group received 30-minute progressive relaxation exercises for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| progressive relaxation exercises | Experimental | Patients in the intervention group received 30-minute progressive relaxation exercises for 6 weeks. Receives: Behavioral: progressive relaxation exercises |
| control | No intervention | Patients in the control group did not receive any intervention other than standard care practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
dyspnea level
Medical Research Council Scale: MMRC is an easily applicable 5-item scale that shows similar results with lung function tests and arterial blood gas measurement and is recommended for use in determining the dyspnea levels of COPD patients in GOLD guidelines. The dyspnea level is graded between 0-4. A score of 0 indicates the absence of dyspnea, and an increase in the rating indicates an increase in the severity of dyspnea.
Measured: baseline, week 3, and week 6
comfort level
The scale consists of 28 items and three sub-dimensions: relief (9 items), relaxation (9 items) and overcoming problems (10 items). The lowest value of 1 indicates a low comfort level and the highest value of 6 indicates a high comfort level. In this study, the Cronbach alpha reliability coefficient of the scale was 0.74 for the intervention group and 0.82 for the control group.
Measured: baseline, week 3, and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Jan 2023
- Primary completion15 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysegul Celik, Izmir Bakircay University
- Investigators
- Ayşegül Çelik, PhD, Principal investigator, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459882
- Sponsor's protocol ID
- BakircaU
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Progressive Relaxation Exercises on Dyspnea and Comfort Level in Individuals With Chronıc Obstructive Lung Disease: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06459882
- Acronym / sponsor ID
- BakircaU
- Conditions
- Copd, Dyspnea, Nursing Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 14 Jun 2024 (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 study is a randomised controlled experimental study conducted to examine the effect of progressive relaxation exercises on dyspnea and comfort level in individuals with chronic obstructive pulmonary disease. The study was conducted between January and August 2023 in the Internal Medicine Clinic of Izmir Urla State Hospital. Stratified and block randomisation method was used in the study and 42 patients, 21 intervention group and 21 control group, were completed. Patients in the intervention group received 30-minute progressive relaxation exercises for 6 weeks. Patients in the control group did not receive any intervention other than standard care practices. The data of the study were collected by face-to-face interview method using the Descriptive Information Form, Medical Research Council Dyspnea Scale, General Comfort Scale-Short Form and Patient Follow-up Form. Descriptive statistics, Shapiro Wilk test, Levene's test, Mauchly's W test, independent sample T test, Mann Whitney U test, dependent sample t test, Wilcoxon Signed Ranks test, Friedman test, Benferoni test and Fisher's Exact test were used to analyse the data obtained from the study. It was determined that the mean dyspnea level scores of the patients in the intervention group at week 6 were lower than the control group and this difference between the groups was statistically significant (p<0.05). It was determined that the decrease in the mean comfort level scores of the patients in the intervention group according to the follow-up periods was statistically significant (p<0.05). According to the results of the study, progressive relaxation exercises can be recommended as an effective nursing intervention to provide dyspnea management in patients with COPD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| progressive relaxation exercises | Experimental | Behavioral: progressive relaxation exercisesPatients in the intervention group received 30-minute progressive relaxation exercises for 6 weeks. |
| control | No intervention | –Patients in the control group did not receive any intervention other than standard care practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age and over
- Inpatient treatment in the Internal Medicine Clinic of Izmir Urla State Hospital
- Standardised Mini Mental Test score ≥24
- Dyspnea severity ≥2 according to the MMRC dyspnoea scale
- Diagnosed with Stage II and Stage III COPD according to GOLD criteria
Key exclusion criteria (3 listed)
- Have any speech and hearing problems
- Lung disease other than COPD, physical dependence and psychiatric illness diagnosed with
- COPD patients in the acute exacerbation period.
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 relaxation exercisesPatients in the intervention group received 30-minute progressive relaxation exercises for 6 weeks | Behavioural | progressive relaxation exercises |
Primary outcome
dyspnea level
Time frame: baseline, week 3, and week 6
Medical Research Council Scale: MMRC is an easily applicable 5-item scale that shows similar results with lung function tests and arterial blood gas measurement and is recommended for use in determining the dyspnea levels of COPD patients in GOLD guidelines. The dyspnea level is graded between 0-4. A score of 0 indicates the absence of dyspnea, and an increase in the rating indicates an increase in the severity of dyspnea.
comfort level
Time frame: baseline, week 3, and week 6
The scale consists of 28 items and three sub-dimensions: relief (9 items), relaxation (9 items) and overcoming problems (10 items). The lowest value of 1 indicates a low comfort level and the highest value of 6 indicates a high comfort level. In this study, the Cronbach alpha reliability coefficient of the scale was 0.74 for the intervention group and 0.82 for the control group.
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 17 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Ayşegül Çelik, PhD principal investigator
Izmir Bakircay University
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 relaxation exercises in people with Copd and Dyspnea, run by Izmir Bakircay 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 8 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 17 Jun 2024. 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?
dyspnea level (time frame: baseline, week 3, and week 6). The study lists 2 primary outcomes in all. 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 17 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.