Clinical trial NCT06185842: The Effectiveness of a Lung Health Promotion Program Based on the 5A Self Management Support Model.
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Disease
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 49
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 6-minute walk distance
timeFrame: 8 weeks
measure: forced vital capacity (FVC)
timeFrame: 8 weeks
measure: forced expiratory volume in one second (FEV1)
timeFrame: 8 weeks
measure: FEV1/FVC ratio
timeFrame: 8 weeks
measure: Physical Activity Scale for the Elderly (PASE)
timeFrame: 8 weeks
measure: health status perception
timeFrame: 8 weeks
measure: sleep quality
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Dr. İsmail Işık Huzurevi Yaşlı Bakım ve Rehabilitasyon Merkezi
state: Meram
Study officials:
affiliation: Selcuk University
name: NURSEZA AKGÖZ, PhD
role: PRINCIPAL_INVESTIGATOR
References: