The Effectiveness of a Lung Health Promotion Program Based on the 5A Self Management Support Model.

July 22, 2025 updated by: NURSEZA AKGÖZ, Selcuk University

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Meram
      • Konya, Meram, Turkey, 42090
        • Dr. İsmail Işık Huzurevi Yaşlı Bakım ve Rehabilitasyon Merkezi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.)
  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group
breathing exercise, walking exercise and vaccination counseling

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

8 weeks
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.
8 weeks
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.
8 weeks
FEV1/FVC ratio
Time Frame: 8 weeks
FEV1/ FVC ratio-The percentage of the FVC expired in one second.
8 weeks
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.

8 weeks
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.

8 weeks
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.

8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: NURSEZA AKGÖZ, PhD, Selcuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2023

Primary Completion (Actual)

January 12, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

December 16, 2023

First Submitted That Met QC Criteria

December 16, 2023

First Posted (Actual)

December 29, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2025

Last Update Submitted That Met QC Criteria

July 22, 2025

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SelcukU-nursing-NA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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