The Effectiveness of a Lung Health Promotion Program Based on the 5A Self Management Support Model.
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.
1 other identifier
interventional
49
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 21, 2023
CompletedFirst Submitted
Initial submission to the registry
December 16, 2023
CompletedFirst Posted
Study publicly available on registry
December 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2024
CompletedJuly 25, 2025
November 1, 2023
2 months
December 16, 2023
July 22, 2025
Conditions
Outcome Measures
Primary Outcomes (7)
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.
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.
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.
8 weeks
FEV1/FVC ratio
FEV1/ FVC ratio-The percentage of the FVC expired in one second.
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.
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.
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.
8 weeks
Study Arms (2)
Intervention group
EXPERIMENTALbreathing exercise, walking exercise and vaccination counseling
Control group
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. İsmail Işık Huzurevi Yaşlı Bakım ve Rehabilitasyon Merkezi
Konya, Meram, 42090, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
NURSEZA AKGÖZ, PhD
Selcuk University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
December 16, 2023
First Posted
December 29, 2023
Study Start
November 21, 2023
Primary Completion
January 12, 2024
Study Completion
February 29, 2024
Last Updated
July 25, 2025
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share