- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06185842
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.
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Meram
-
Konya, Meram, Turkey, 42090
- Dr. İsmail Işık Huzurevi Yaşlı Bakım ve Rehabilitasyon Merkezi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: NURSEZA AKGÖZ, PhD, Selcuk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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