AnxietyNCT04559503
Progressive Relaxation Exercises in COPD
A study testing Progressive relaxation exercises in people with Anxiety and Dyspnea, run by Nigde Omer Halisdemir University.
Trial summary
Background: This study aimed to determine the effect of progressive relaxation exercises (PMR) on dyspnea and anxiety level in individuals with COPD Methods: The study was conducted in the pretest-posttest randomized-controlled trial and completed with 44 COPD individuals, 22 interventions and 22 controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Progressive relaxation exercises
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2016to 15 Sep 2017
- 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
- Diagnosed with COPD,
- Must be able to competence to answer the questionnaire questions,
- Must be able to communicate verbally,
- Over 18 years of age,
- To have 2nd or 3rd grade COPD according to the GOLD Guide Staging System,
- To have 2 or more severe dyspnea according to the mMRC Dyspnea Scale,
- No medication changes have been made in the last three months,
- Not having received pulmonary rehabilitation in the last 6 months,
Who cannot join
- To have severe psychological disorders,
- To have non-COPD pulmonary diseases,
- To have cancer,
- To have renal failure,
- To have thyroid dysfunction,
- To have liver dysfunction
About this study
Official title: The Effect of Progressive Relaxation Exercises on Dyspnea and Anxiety Levels in Individuals With COPD
Background: This study aimed to determine the effect of progressive relaxation exercises (PMR) on dyspnea and anxiety level in individuals with COPD Methods: The study was conducted in the pretest-posttest randomized-controlled trial and completed with 44 COPD individuals, 22 interventions and 22 controls. PMR were applied once a day for four weeks in the intervention group in addition to the standard treatments. The control group received standard treatment.
Read the detailed description
Background: This study aimed to determine the effect of progressive relaxation exercises (PMR) on dyspnea and anxiety level in individuals with COPD Methods: The study was conducted in the pretest-posttest randomized-controlled trial and completed with 44 COPD individuals, 22 interventions and 22 controls. PMR were applied once a day for four weeks in the intervention group in addition to the standard treatments. The control group received standard treatment. For data collection Questionnaire Forms, Patient Follow-Up Schedules, Modified Borg Scale (MBS), Modified British Medical Research Council Dyspnea Scale (mMRC), COPD Assessment Test (CAT), and Beck Anxiety Scale were used.
- Being tested
- Progressive relaxation exercises
- Medical subject headings
- Anxiety Disorders, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive relaxation exercisesOther
Progressive relaxation exercises are those involving the voluntary, regular and consecutive relaxation of the muscles until there is relaxation all over the body. PMR are consisted of taking a deep breath and then tensing and relaxing muscles in both hands and arms, shoulders, chest, abdomen, hips, legs, feet, and face regions. The training was given in line with the CD that was prepared by the Turkish Psychologists Association as three-part relaxation exercises. The first part of the CD contains the definition, purpose and applications to consider when doing the exercises and a definition of 10-minute deep relaxation. In the second 30-minute section, relaxation exercises are explained accompanied by the sound of streams and oral instructions. The last section, which consists of 30 minutes, contains only relaxation music without instructions.
| Study group | Role | What they receive |
|---|---|---|
| İntervention Group | Experimental | Progressive relaxation exercises were applied once a day for four weeks in the intervention group in addition to the standard treatments. The patients were called 3 times each week on the telephone, and it was monitored whether they continued to do the exercises. Receives: Other: Progressive relaxation exercises |
| Control group | No intervention | The control group received standard treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Borg Scale
The Modified Borg Scale was developed by Borg in 1970 to measure the effort that is spent during physical exercise. It is a scale that is often used to assess the exertion dyspnea severity and resting dyspnea severity. There are 10 items that define the severity of the dyspnea according to their degrees. The scoring is made between 0 (none) and 10 (very severe)
Measured: change from baseline score at the end of four weeks
Modified British Medical Research Council Dyspnea Scale
Fletcher et al. developed the mMRC Dyspnea Scale in 1940s when he worked on the respiratory problems of the coal workers. Then, the British Medical Research Board developed this scale more, and used to monitor the natural course of the disease. There are 5 grade (grade 0 to grade 4) that define the description of breathlessness on various physical activities, which cause dyspnea sense.
Grade 0: breathless with strenuous exercise; Grade 1: short of breath when hurrying on level ground or walking up a slight hill; Grade 2: walked slower than people of the same age on level ground, and experienced breathlessness or the need to stop to breathe when walking on level ground at their own pace; Grade 3: stop to breathe after walking about 100 yards, or after a few minutes on level ground; and Grade 4: too breathless to leave the house, or breathless when dressing / undressing.
Measured: change from baseline score at the end of four weeks
COPD Assessment Test
It was developed by Jones et al. in 2009. The Turkish reliability and validity of it was conducted in 2012 by Yorgancıoğlu et al. (2012). It is an easy, 8-item, and short scale that clinically measures the effects of COPD and deterioration in health conditions. The lowest score that can be received from the scale is 0, and the highest score is 40.
Measured: change from baseline score at the end of four weeks
Beck Anxiety Scale
This scale, which can distinguish anxiety from depression, was developed by Beck et al. (1988). The validity and reliability studies of the scale were conducted for Turkey by Ulusoy et al. in 1998. The scale measures the frequency of the anxiety symptoms of the individuals with self-evaluation. It is a 4-Point Likert scale, and consists of 21 items. The scores range between 0 and 63. According to the scores received from the scale, the anxiety levels of patients are assessed as 0-7 points: minimal, 8-15 points: mild, 16-25 points moderate, 26 and above points: severe anxiety level.
Measured: change from baseline score at the end of four weeks
Patient Follow-Up Schedule
The Patient Follow-Up Schedule is the form in which the first follow-up (the first interview), the second follow-up (the second interview after 4 weeks), the results of the respiratory function, and the emergency admission status of the patients were recorded by the researcher.
Measured: change from baseline score at the end of four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start15 Nov 2016
- Primary completion15 Nov 2016
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Collaborators
- TC Erciyes University
- Responsible party
- Principal investigator, Züleyha Kılıç, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559503
- Sponsor's protocol ID
- OHU-zuleyha
- Status last verified
- Sep 2020
- First submitted
- 13 Sep 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercises on Dyspnea and Anxiety Levels in Individuals With COPD
- ClinicalTrials.gov ID
- NCT04559503
- Acronym / sponsor ID
- OHU-zuleyha
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Collaborators
- TC Erciyes University
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 23 Sep 2020 (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.
Background: This study aimed to determine the effect of progressive relaxation exercises (PMR) on dyspnea and anxiety level in individuals with COPD Methods: The study was conducted in the pretest-posttest randomized-controlled trial and completed with 44 COPD individuals, 22 interventions and 22 controls. PMR were applied once a day for four weeks in the intervention group in addition to the standard treatments. The control group received standard treatment.
Detailed description
Background: This study aimed to determine the effect of progressive relaxation exercises (PMR) on dyspnea and anxiety level in individuals with COPD Methods: The study was conducted in the pretest-posttest randomized-controlled trial and completed with 44 COPD individuals, 22 interventions and 22 controls. PMR were applied once a day for four weeks in the intervention group in addition to the standard treatments. The control group received standard treatment. For data collection Questionnaire Forms, Patient Follow-Up Schedules, Modified Borg Scale (MBS), Modified British Medical Research Council Dyspnea Scale (mMRC), COPD Assessment Test (CAT), and Beck Anxiety Scale were used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntervention Group | Experimental | Other: Progressive relaxation exercisesProgressive relaxation exercises were applied once a day for four weeks in the intervention group in addition to the standard treatments. The patients were called 3 times each week on the telephone, and it was monitored whether they continued to do the exercises. |
| Control group | No intervention | –The control group received standard treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with COPD,
- Must be able to competence to answer the questionnaire questions,
- Must be able to communicate verbally,
- Over 18 years of age,
- To have 2nd or 3rd grade COPD according to the GOLD Guide Staging System,
Key exclusion criteria (6 listed)
- To have severe psychological disorders,
- To have non-COPD pulmonary diseases,
- To have cancer,
- To have renal failure,
- To have thyroid dysfunction,
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 exercisesProgressive relaxation exercises are those involving the voluntary, regular and consecutive relaxation of the muscles until there is relaxation all over the body. PMR are consisted of taking a deep breath and then tensing and relaxing muscles in both hands and arms, shoulders, chest, abdomen, hips, legs, feet, and face regions. The training was given in line with the CD that was prepared by the Turkish Psychologists Association as three-part relaxation exercises. The first part of the CD contains the definition, purpose and applications to consider when doing the exercises and a definition of 10-minute deep relaxation. In the second 30-minute section, relaxation exercises are explained accompanied by the sound of streams and oral instructions. The last section, which consists of 30 minutes, contains only relaxation music without instructions. | Other | İntervention Group |
Primary outcome
Modified Borg Scale
Time frame: change from baseline score at the end of four weeks
The Modified Borg Scale was developed by Borg in 1970 to measure the effort that is spent during physical exercise. It is a scale that is often used to assess the exertion dyspnea severity and resting dyspnea severity. There are 10 items that define the severity of the dyspnea according to their degrees. The scoring is made between 0 (none) and 10 (very severe)
Modified British Medical Research Council Dyspnea Scale
Time frame: change from baseline score at the end of four weeks
Fletcher et al. developed the mMRC Dyspnea Scale in 1940s when he worked on the respiratory problems of the coal workers. Then, the British Medical Research Board developed this scale more, and used to monitor the natural course of the disease. There are 5 grade (grade 0 to grade 4) that define the description of breathlessness on various physical activities, which cause dyspnea sense. Grade 0: breathless with strenuous exercise; Grade 1: short of breath when hurrying on level ground or walking up a slight hill; Grade 2: walked slower than people of the same age on level ground, and experienced breathlessness or the need to stop to breathe when walking on level ground at their own pace; Grade 3: stop to breathe after walking about 100 yards, or after a few minutes on level ground; and Grade 4: too breathless to leave the house, or breathless when dressing / undressing.
COPD Assessment Test
Time frame: change from baseline score at the end of four weeks
It was developed by Jones et al. in 2009. The Turkish reliability and validity of it was conducted in 2012 by Yorgancıoğlu et al. (2012). It is an easy, 8-item, and short scale that clinically measures the effects of COPD and deterioration in health conditions. The lowest score that can be received from the scale is 0, and the highest score is 40.
Beck Anxiety Scale
Time frame: change from baseline score at the end of four weeks
This scale, which can distinguish anxiety from depression, was developed by Beck et al. (1988). The validity and reliability studies of the scale were conducted for Turkey by Ulusoy et al. in 1998. The scale measures the frequency of the anxiety symptoms of the individuals with self-evaluation. It is a 4-Point Likert scale, and consists of 21 items. The scores range between 0 and 63. According to the scores received from the scale, the anxiety levels of patients are assessed as 0-7 points: minimal, 8-15 points: mild, 16-25 points moderate, 26 and above points: severe anxiety level.
Patient Follow-Up Schedule
Time frame: change from baseline score at the end of four weeks
The Patient Follow-Up Schedule is the form in which the first follow-up (the first interview), the second follow-up (the second interview after 4 weeks), the results of the respiratory function, and the emergency admission status of the patients were recorded by the researcher.
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 Sep 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive relaxation exercises in people with Anxiety and Dyspnea, run by Nigde Omer Halisdemir University.
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 6 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 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Modified Borg Scale (time frame: change from baseline score at the end of four weeks). The study lists 5 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 23 Sep 2020.