Pulmonary DiseaseNCT06185842
The Effectiveness of a Lung Health Promotion Program Based on the 5A Self Management Support Model.
A study testing breathing exercise, walking exercise and vaccination counseling in people with Pulmonary Disease, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This research will be conducted to examine the effect of the lung health promotion program based on the 5A self-management support model on some physiological parameters, Physical Activity Scale in the Elderly score, sleep quality, health status perception and vaccination status of adults aged 65 and over. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- breathing exercise, walking exercise and vaccination counseling
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Nov 2023to 29 Feb 2024
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 60 years or older
- Being literate / Being able to read and write Turkish
- Scoring 24 or above on the Standardize Mini Mental Test Examination
- No bilateral vision or bilateral hearing problems
- Not having an acute or chronic systemic disease that would prevent breathing exercise (pulmonary hypertension, angina pectoris, recent myocardial infarction, aortic stenosis, congestive heart failure, heart valve disease, abdominal aortic aneurysm, unstable diabetes, hypoxemia that cannot be corrected by oxygen supplementation due to heavy exercise, severe peripheral vascular disease, recent deep vein thrombosis etc.)
- Having no musculoskeletal system problems that prevent walking (arthritis, musculoskeletal injuries etc.)
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- Not having had a recent surgical intervention (cataract surgery, ear, brain, spinal cord surgery, diaphragmatic rupture, hiatus or abdominal hernia repair surgery etc.)
- Not having severe liver disease and active substance addiction
- Not having advanced dementia, cognitive and psychological disorders, psychiatric diseases and serious neurological diseases.
Who cannot join
- Having an acute problem or complication related to existing chronic diseases
- Withdrawing from the research voluntarily. However, the data of this group of elderly people will be analyzed with intention to treat (ITT) analysis.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. İsmail Işık Huzurevi Yaşlı Bakım ve Rehabilitasyon Merkezi
Konya, Meram, 42090
About this study
Official title: The Effectiveness of a Comprehensive Lung Health Promotion Program Based on the 5A Self-management Support Model for the Elderly in Nursing Home: A Randomized Controlled Trial.
This research will be conducted to examine the effect of the lung health promotion program based on the 5A self-management support model on some physiological parameters, Physical Activity Scale in the Elderly score, sleep quality, health status perception and vaccination status of adults aged 65 and over.
The research will be carried out as a randomized controlled study with a parallel design.
We estimate that the respiratory functions of the elderly will improve, their physical activity levels will increase, immunization against common infectious diseases will increase and people's health perceptions will improve. with the lung health promotion program based on the 5A self-management support model.
Read the detailed description
The population of the research consisted of 312 individuals aged 60 and over living in an elderly care and rehabilitation center.
In the sample calculation of the research, taking into account the GPower 3.1.9.7 program and the results of similar studies in the literature, it was calculated that it would be sufficient to include a total of 42 individuals, 21 elderly individuals in each group, with a margin of error of 0.05 and a test power of 80%.
Considering that there may be losses during the process in such studies, 5% of the sample number (2.1~2 people) was added to the study. The study was planned to include 22 elderly individuals in the intervention group and 22 elderly individuals in the control group.
A program to improve lung health will be applied to the elderly in the experimental group.
Within the scope of the research, participants; They will do diaphragmatic breathing exercises and pursed lip breathing exercises 2 days a week for 8 weeks.
Participants will be asked to walk for 20-30 minutes every day for eight weeks. Monitoring will be done weekly.
Participants will be counseled about infectious diseases, modes of transmission and the importance of vaccination, and will be advised to receive influenza and pneumococcal vaccines recommended for this age group.
The 5A model guide will be used regarding behavioral change towards physical activity and vaccination.
- Conditions
- Pulmonary Disease
- Being tested
- breathing exercise, walking exercise and vaccination counseling
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breathing exercise, walking exercise and vaccination counselingBehavioural
Participants will perform diaphragmatic breathing exercises and pursed lip breathing exercises two days a week for eight weeks.
Participants will be asked to walk for 20-30 minutes every day for eight weeks. Monitoring will be done weekly.
Participants will be counseled about infectious diseases, modes of transmission and the importance of vaccination, and will be advised to receive influenza and pneumococcal vaccines recommended for this age group.
The 5A model guide will be used regarding behavioral change towards physical activity and vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | breathing exercise, walking exercise and vaccination counseling Receives: Behavioral: breathing exercise, walking exercise and vaccination counseling |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk distance
The six-minute walk test (6MWT) is an exercise test used to evaluate walking endurance and aerobic capacity. This test measures the distance the patient can walk quickly on a flat, hard surface in a 6-minute period.
It is reported that the distance walked for six minutes varies between 400-700m in normal individuals.
The distance the person is expected to walk during the test is calculated based on age, gender, height and body mass index. It is accepted that the distance recorded in the test provides information about the person's exercise capacity during daily living activities.
Measured: 8 weeks
forced vital capacity (FVC)
FVC-Forced vital capacity; the total volume of air that can be exhaled during a maximal forced expiration effort.
Measured: 8 weeks
forced expiratory volume in one second (FEV1)
FEV1-Forced expiratory volume in one second; the volume of air exhaled in the first second under force after a maximal inhalation.
Measured: 8 weeks
FEV1/FVC ratio
FEV1/ FVC ratio-The percentage of the FVC expired in one second.
Measured: 8 weeks
Physical Activity Scale for the Elderly (PASE)
The PASE was developed for the purpose of evaluating the components of physical activities involving leisure time, work-related activities, and the household.
The PASE is a self-reported questionnaire that consists of 12 questions regarding the frequency and duration of leisure time activity, household activity, and work-related activity during the previous 7-day period.
The questions are scored differently. Participation in leisure time and strengthening activities are scored as never, seldom (1 or 2 days per week), sometimes (3 or 4 days per week), and often (5-7 days per week). Duration of these activities is scored as less than 1 h, 1-2 h, 2-4 h, and more than 4 h.
The overall PASE score ranges from 0 to 400 or more and high scores show better physical activity levels.
Measured: 8 weeks
health status perception
To determine their perception of health status, participants are asked to evaluate their general health status over the past 15 days using a visual analog scale.
Accordingly, the participant marks an integer score from 0 to 10 according to the following five categories: 0 = terrible, 1- 3 = poor, 4-6 = fair, 7-9 = good, and 10 = excellent.
Measured: 8 weeks
sleep quality
The single-item sleep quality scale (SQS) is a practical measurement tool that can effectively measure sleep quality in the clinical setting.
A visual analog scale is used to rate the individual's overall sleep quality over the past seven days.
In this way, the participant marks an integer score from 0 to 10 according to the following five categories: 0 = terrible, 1- 3 = poor, 4-6 = fair, 7-9 = good, and 10 = excellent.
When rating their sleep quality, participants are asked to consider the following key components of sleep quality: how many hours they slept, how easily they fell asleep, how often they woke up during the night (other than to go to the toilet), how often they woke up early in the morning, and how restful their sleep was.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start21 Nov 2023
- Primary completion12 Jan 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NURSEZA AKGÖZ, Selcuk University
- Investigators
- NURSEZA AKGÖZ, PhD, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185842
- Sponsor's protocol ID
- SelcukU-nursing-NA-01
- Status last verified
- Nov 2023
- First submitted
- 16 Dec 2023
- Last updated
- 25 Jul 2025
- 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 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Comprehensive Lung Health Promotion Program Based on the 5A Self-management Support Model for the Elderly in Nursing Home: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06185842
- Acronym / sponsor ID
- SelcukU-nursing-NA-01
- Conditions
- Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 29 Dec 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.
This research will be conducted to examine the effect of the lung health promotion program based on the 5A self-management support model on some physiological parameters, Physical Activity Scale in the Elderly score, sleep quality, health status perception and vaccination status of adults aged 65 and over.
The research will be carried out as a randomized controlled study with a parallel design.
We estimate that the respiratory functions of the elderly will improve, their physical activity levels will increase, immunization against common infectious diseases will increase and people's health perceptions will improve. with the lung health promotion program based on the 5A self-management support model.
Detailed description
The population of the research consisted of 312 individuals aged 60 and over living in an elderly care and rehabilitation center.
In the sample calculation of the research, taking into account the GPower 3.1.9.7 program and the results of similar studies in the literature, it was calculated that it would be sufficient to include a total of 42 individuals, 21 elderly individuals in each group, with a margin of error of 0.05 and a test power of 80%.
Considering that there may be losses during the process in such studies, 5% of the sample number (2.1~2 people) was added to the study. The study was planned to include 22 elderly individuals in the intervention group and 22 elderly individuals in the control group.
A program to improve lung health will be applied to the elderly in the experimental group.
Within the scope of the research, participants; They will do diaphragmatic breathing exercises and pursed lip breathing exercises 2 days a week for 8 weeks.
Participants will be asked to walk for 20-30 minutes every day for eight weeks. Monitoring will be done weekly.
Participants will be counseled about infectious diseases, modes of transmission and the importance of vaccination, and will be advised to receive influenza and pneumococcal vaccines recommended for this age group.
The 5A model guide will be used regarding behavioral change towards physical activity and vaccination.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: breathing exercise, walking exercise and vaccination counselingbreathing exercise, walking exercise and vaccination counseling |
| Control group | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Being 60 years or older
- Being literate / Being able to read and write Turkish
- Scoring 24 or above on the Standardize Mini Mental Test Examination
- No bilateral vision or bilateral hearing problems
- Not having an acute or chronic systemic disease that would prevent breathing exercise (pulmonary hypertension, angina pectoris, recent myocardial infarction, aortic stenosis, congestive heart failure, heart valve disease, abdominal aortic aneurysm, unstable diabetes, hypoxemia that cannot be corrected by oxygen supplementation due to heavy exercise, severe peripheral vascular disease, recent deep vein thrombosis etc.)
Key exclusion criteria (2 listed)
- Having an acute problem or complication related to existing chronic diseases
- Withdrawing from the research voluntarily. However, the data of this group of elderly people will be analyzed with intention to treat (ITT) analysis.
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 |
|---|---|---|
| breathing exercise, walking exercise and vaccination counselingParticipants will perform diaphragmatic breathing exercises and pursed lip breathing exercises two days a week for eight weeks. Participants will be asked to walk for 20-30 minutes every day for eight weeks. Monitoring will be done weekly. Participants will be counseled about infectious diseases, modes of transmission and the importance of vaccination, and will be advised to receive influenza and pneumococcal vaccines recommended for this age group. The 5A model guide will be used regarding behavioral change towards physical activity and vaccination. | Behavioural | Intervention group |
Primary outcome
6-minute walk distance
Time frame: 8 weeks
The six-minute walk test (6MWT) is an exercise test used to evaluate walking endurance and aerobic capacity. This test measures the distance the patient can walk quickly on a flat, hard surface in a 6-minute period. It is reported that the distance walked for six minutes varies between 400-700m in normal individuals. The distance the person is expected to walk during the test is calculated based on age, gender, height and body mass index. It is accepted that the distance recorded in the test provides information about the person's exercise capacity during daily living activities.
forced vital capacity (FVC)
Time frame: 8 weeks
FVC-Forced vital capacity; the total volume of air that can be exhaled during a maximal forced expiration effort.
forced expiratory volume in one second (FEV1)
Time frame: 8 weeks
FEV1-Forced expiratory volume in one second; the volume of air exhaled in the first second under force after a maximal inhalation.
FEV1/FVC ratio
Time frame: 8 weeks
FEV1/ FVC ratio-The percentage of the FVC expired in one second.
Physical Activity Scale for the Elderly (PASE)
Time frame: 8 weeks
The PASE was developed for the purpose of evaluating the components of physical activities involving leisure time, work-related activities, and the household. The PASE is a self-reported questionnaire that consists of 12 questions regarding the frequency and duration of leisure time activity, household activity, and work-related activity during the previous 7-day period. The questions are scored differently. Participation in leisure time and strengthening activities are scored as never, seldom (1 or 2 days per week), sometimes (3 or 4 days per week), and often (5-7 days per week). Duration of these activities is scored as less than 1 h, 1-2 h, 2-4 h, and more than 4 h. The overall PASE score ranges from 0 to 400 or more and high scores show better physical activity levels.
health status perception
Time frame: 8 weeks
To determine their perception of health status, participants are asked to evaluate their general health status over the past 15 days using a visual analog scale. Accordingly, the participant marks an integer score from 0 to 10 according to the following five categories: 0 = terrible, 1- 3 = poor, 4-6 = fair, 7-9 = good, and 10 = excellent.
sleep quality
Time frame: 8 weeks
The single-item sleep quality scale (SQS) is a practical measurement tool that can effectively measure sleep quality in the clinical setting. A visual analog scale is used to rate the individual's overall sleep quality over the past seven days. In this way, the participant marks an integer score from 0 to 10 according to the following five categories: 0 = terrible, 1- 3 = poor, 4-6 = fair, 7-9 = good, and 10 = excellent. When rating their sleep quality, participants are asked to consider the following key components of sleep quality: how many hours they slept, how easily they fell asleep, how often they woke up during the night (other than to go to the toilet), how often they woke up early in the morning, and how restful their sleep was.
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 25 Jul 2025.
- 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.
NURSEZA AKGÖZ, PhD principal investigator
Selcuk 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 breathing exercise, walking exercise and vaccination counseling in people with Pulmonary Disease, run by Selcuk 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 9 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 25 Jul 2025. 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?
6-minute walk distance (time frame: 8 weeks). The study lists 7 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 25 Jul 2025.