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

Pulmonary Disease Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06185842
• Other study ID #: SelcukU-nursing-NA-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 24, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: December 2023
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: February 29, 2024
• Est. primary completion date: January 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Turkey	Dr. Ismail Isik Huzurevi Yasli Bakim ve Rehabilitasyon Merkezi	Konya	Meram

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	FEV1/FVC ratio	FEV1/ FVC ratio-The percentage of the FVC expired in one second.	8 weeks
Primary	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
Primary	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
Primary	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