Progressive Muscle RelaxationNCT05846204
Progressive Muscle Relaxation and Deep Breathing Exercises
A study testing Progressive Muscle Relaxation and Deep Breathing Exercise Group-DBE in people with Progressive Muscle Relaxation and Deep Breath, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The population of the study was composed of 186 patients whose cells were assigned to Atatürk University Hospital Educational Diseases Polyclinic between April and June 2023, and whose cells were found to have COPD according to the Chronic Obstructive Pulmonary Disease Initiative by the physician. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Progressive Muscle Relaxation, Deep Breath, COPD
- What is being tested?
- Progressive Muscle Relaxation and Deep Breathing Exercise Group-DBE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 15 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not having any physical problems
- Conscious
- Fully oriented
- Not have an acute exacerbation attack in the past month
Who cannot join
- Having a hearing problem,
- Inability to practice relaxation exercises regularly,
- Wanting to leave the study
- Neurological diseases,
- Those with comorbidities such as acute myocardial infarction or cancer,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Progressive Muscle Relaxation and Deep Breathing Exercises Training on Dyspnea, Fatigue and, Quality of Sleep in Patients With COPD: A Randomized Controlled Clinical Trial
The population of the study was composed of 186 patients whose cells were assigned to Atatürk University Hospital Educational Diseases Polyclinic between April and June 2023, and whose cells were found to have COPD according to the Chronic Obstructive Pulmonary Disease Initiative by the physician. A total of 140 patients approved the inclusion criteria and agreed to participate in the study. Priori power analysis was performed for sampling determination. In the power analysis, Cohen's medium effect size reference method was chosen. As a result of the power analysis, it was determined that it should be done with a total of 90 patients, 30 patients in each group, two experimental groups and the control group (α=0.05, power=0.8, and effect expectation=0.65). In case of data loss, this number plus approximately 20% reserve allocation included 36 patients in each group. However, the study was completed with a total of 96 patients, including PMR(n=31), DB(n=32) and 33 control subjects.
Read the detailed description
The PMR exercise, which includes the systematic relaxation of the main muscle groups of the body aimed at physical and psychological relaxation, was applied twice a day, every weekday, for eight weeks. PMR exercises and these exercises were given to the patients individually.
The training for the implementation of the exercises was given by face-to-face interview method. During the training process, "Muscle Relaxation Exercises Practice Guide" and "Relaxation Exercises Audio Recordings", which were prepared by the researcher and included relaxation exercises, were used.
Deep Breath exercises training was given to the patients in this group individually by face-to-face interview. During the application, the importance of deep and comfortable breathing was explained and correct breathing technique was taught. Informing and application training took an average of 20-25 minutes for each patient. The patients were told to do the 10-minute application at home 3 times a day for 8 weeks. They were called once a week and asked whether they continued the practice and whether they had any difficulties during the exercises.
- Conditions
- Progressive Muscle Relaxation, Deep Breath, COPD
- Being tested
- Progressive Muscle Relaxation, Deep Breathing Exercise Group-DBE
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle RelaxationBehavioural
The PMR exercise, which includes the systematic relaxation of the main muscle groups of the body aimed at physical and psychological relaxation, was applied twice a day, every weekday, for eight weeks.
DB exercises training was given to the patients in this group individually by face-to-face interview. During the application, the importance of deep and comfortable breathing was explained and correct breathing technique was taught.
Deep Breathing Exercise Group-DBEBehavioural
Breathing exercise is an exercise to improve breathing and functional performance. deep breathing exercise; It is a nursing intervention that helps to increase the function of respiratory muscles and improve ventilation and oxygenation.
| Study group | Role | What they receive |
|---|---|---|
| PMR Group | Experimental | The PMR exercise, which includes the systematic relaxation of the main muscle groups of the body aimed at physical and psychological relaxation, was applied twice a day, every weekday, for eight weeks. PMR exercises and training on the application of these exercises were given to the patients individually by face-to-face interview method. During the training process, "Muscle Relaxation Exercises Practice Guide" and "Relaxation Exercises Audio Recordings", which were prepared by the researcher and included relaxation exercises, were used. Voice recordings were uploaded to each patient's mobile phone so that they could continue the application at home. The steps of the relaxation exercises were explained to the patient by the researcher and he was shown exactly how to do the exercises. Receives: Behavioral: Progressive Muscle Relaxation |
| Deep Breath Group | Experimental | WB exercises training was given to the patients in this group individually by face-to-face interview. During the application, the importance of deep and comfortable breathing was explained and correct breathing technique was taught. Informing and application training took an average of 20-25 minutes for each patient. The patients were told to do the 10-minute application at home 3 times a day for 8 weeks. They were called once a week and asked whether they continued the practice and whether they had any difficulties during the exercises. Receives: Behavioral: Deep Breathing Exercise Group-DBE |
| Control | No intervention | No intervention will be applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Obstructive Pulmonary Disease and Asthma Fatigue Scale
The COPD and Asthma Fatigue Scale (CAFS) was developed by Revicki et al. In the scale consisting of a total of 12 questions, the items of the questions are graded in a Likert type. The total raw score is obtained by summing all item scores, and the raw scores are converted to a total scale score between 0 and 100 points. The increase in the scale score indicates the increase in the fatigue level of the person.
Measured: two week
Dyspnea-12 Scale
The scale developed by Yorke et al. consists of 12 items measuring the severity of dyspnea. It consists of 4-point Likert type options. The highest score that can be obtained from the physical sub-dimension of the scale is 21, and the highest score that can be obtained from the emotional sub-dimension is 15. The lowest score of the scale is 0, and the highest score is 36. An increase in the score obtained from the scale indicates an increase in the severity of dyspnea.
Measured: Two week
Pittsburgh Sleep Quality Index
Designed by PSQI, Buysee et al. PSQI specifically measures subjective sleep quality over a one-month period. The PSQI includes 19 items on seven subscales: subjective sleep quality, sleep duration, sleep disturbance, sleep delay, sleep efficiency, use of sleep medication, and daytime dysfunction. Items are scored on a 4-point Likert scale from 0 to 3 points. Scores of the subscales are added to an overall PSQI score. The total score of the questionnaire ranges from 1 to 21 points, where scores higher than 5 indicate poor sleep quality and scores lower than 5 indicate no sleep disturbance.
Measured: Two week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start15 Apr 2023
- Primary completion15 May 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Muscle RelaxationStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NİHAN TÜRKOĞLU, Ataturk University
- Investigators
- Nihan Türkoğlu, Assist.Prof., Study chair, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846204
- Sponsor's protocol ID
- AtaturkUnıv
- Status last verified
- Jul 2023
- First submitted
- 26 Apr 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- 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 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Muscle Relaxation and Deep Breathing Exercises Training on Dyspnea, Fatigue and, Quality of Sleep in Patients With COPD: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05846204
- Acronym / sponsor ID
- AtaturkUnıv
- Conditions
- Progressive Muscle Relaxation, Deep Breath, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 6 May 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 population of the study was composed of 186 patients whose cells were assigned to Atatürk University Hospital Educational Diseases Polyclinic between April and June 2023, and whose cells were found to have COPD according to the Chronic Obstructive Pulmonary Disease Initiative by the physician. A total of 140 patients approved the inclusion criteria and agreed to participate in the study. Priori power analysis was performed for sampling determination. In the power analysis, Cohen's medium effect size reference method was chosen. As a result of the power analysis, it was determined that it should be done with a total of 90 patients, 30 patients in each group, two experimental groups and the control group (α=0.05, power=0.8, and effect expectation=0.65). In case of data loss, this number plus approximately 20% reserve allocation included 36 patients in each group. However, the study was completed with a total of 96 patients, including PMR(n=31), DB(n=32) and 33 control subjects.
Detailed description
The PMR exercise, which includes the systematic relaxation of the main muscle groups of the body aimed at physical and psychological relaxation, was applied twice a day, every weekday, for eight weeks. PMR exercises and these exercises were given to the patients individually.
The training for the implementation of the exercises was given by face-to-face interview method. During the training process, "Muscle Relaxation Exercises Practice Guide" and "Relaxation Exercises Audio Recordings", which were prepared by the researcher and included relaxation exercises, were used.
Deep Breath exercises training was given to the patients in this group individually by face-to-face interview. During the application, the importance of deep and comfortable breathing was explained and correct breathing technique was taught. Informing and application training took an average of 20-25 minutes for each patient. The patients were told to do the 10-minute application at home 3 times a day for 8 weeks. They were called once a week and asked whether they continued the practice and whether they had any difficulties during the exercises.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PMR Group | Experimental | Behavioral: Progressive Muscle RelaxationThe PMR exercise, which includes the systematic relaxation of the main muscle groups of the body aimed at physical and psychological relaxation, was applied twice a day, every weekday, for eight weeks. PMR exercises and training on the application of these exercises were given to the patients individually by face-to-face interview method. During the training process, "Muscle Relaxation Exercises Practice Guide" and "Relaxation Exercises Audio Recordings", which were prepared by the researcher and included relaxation exercises, were used. Voice recordings were uploaded to each patient's mobile phone so that they could continue the application at home. The steps of the relaxation exercises were explained to the patient by the researcher and he was shown exactly how to do the exercises. |
| Deep Breath Group | Experimental | Behavioral: Deep Breathing Exercise Group-DBEWB exercises training was given to the patients in this group individually by face-to-face interview. During the application, the importance of deep and comfortable breathing was explained and correct breathing technique was taught. Informing and application training took an average of 20-25 minutes for each patient. The patients were told to do the 10-minute application at home 3 times a day for 8 weeks. They were called once a week and asked whether they continued the practice and whether they had any difficulties during the exercises. |
| Control | No intervention | –No intervention will be applied to the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Not having any physical problems
- Conscious
- Fully oriented
- Not have an acute exacerbation attack in the past month
Key exclusion criteria (5 listed)
- Having a hearing problem,
- Inability to practice relaxation exercises regularly,
- Wanting to leave the study
- Neurological diseases,
- Those with comorbidities such as acute myocardial infarction or cancer,
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 RelaxationThe PMR exercise, which includes the systematic relaxation of the main muscle groups of the body aimed at physical and psychological relaxation, was applied twice a day, every weekday, for eight weeks. DB exercises training was given to the patients in this group individually by face-to-face interview. During the application, the importance of deep and comfortable breathing was explained and correct breathing technique was taught. | Behavioural | PMR Group |
| Deep Breathing Exercise Group-DBEBreathing exercise is an exercise to improve breathing and functional performance. deep breathing exercise; It is a nursing intervention that helps to increase the function of respiratory muscles and improve ventilation and oxygenation. | Behavioural | Deep Breath Group |
Primary outcome
Chronic Obstructive Pulmonary Disease and Asthma Fatigue Scale
Time frame: two week
The COPD and Asthma Fatigue Scale (CAFS) was developed by Revicki et al. In the scale consisting of a total of 12 questions, the items of the questions are graded in a Likert type. The total raw score is obtained by summing all item scores, and the raw scores are converted to a total scale score between 0 and 100 points. The increase in the scale score indicates the increase in the fatigue level of the person.
Dyspnea-12 Scale
Time frame: Two week
The scale developed by Yorke et al. consists of 12 items measuring the severity of dyspnea. It consists of 4-point Likert type options. The highest score that can be obtained from the physical sub-dimension of the scale is 21, and the highest score that can be obtained from the emotional sub-dimension is 15. The lowest score of the scale is 0, and the highest score is 36. An increase in the score obtained from the scale indicates an increase in the severity of dyspnea.
Pittsburgh Sleep Quality Index
Time frame: Two week
Designed by PSQI, Buysee et al. PSQI specifically measures subjective sleep quality over a one-month period. The PSQI includes 19 items on seven subscales: subjective sleep quality, sleep duration, sleep disturbance, sleep delay, sleep efficiency, use of sleep medication, and daytime dysfunction. Items are scored on a 4-point Likert scale from 0 to 3 points. Scores of the subscales are added to an overall PSQI score. The total score of the questionnaire ranges from 1 to 21 points, where scores higher than 5 indicate poor sleep quality and scores lower than 5 indicate no sleep disturbance.
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 19 Jul 2023.
- 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.
Nihan Türkoğlu, Assist.Prof. study chair
Ataturk 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 Muscle Relaxation and Deep Breathing Exercise Group-DBE in people with Progressive Muscle Relaxation and Deep Breath, run by Ataturk 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 4 inclusion and 5 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 19 Jul 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?
Chronic Obstructive Pulmonary Disease and Asthma Fatigue Scale (time frame: two week). The study lists 3 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 19 Jul 2023.