NCT06185842

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 29, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

July 25, 2025

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

December 16, 2023

Last Update Submit

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

EXPERIMENTAL

breathing exercise, walking exercise and vaccination counseling

Behavioral: breathing exercise, walking exercise and vaccination counseling

Control group

NO INTERVENTION

Interventions

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.

Intervention group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • NURSEZA AKGÖZ, PhD

    Selcuk University

    PRINCIPAL INVESTIGATOR

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

Locations