Evaluation in Elderly Individuals with Chronic Obstructive Pulmonary Disease(COPD)
Evaluation of Balance, Physical Activity, Functional Capacity and Activities of Daily Living in Frail Elderly Individuals with COPD
1 other identifier
observational
54
1 country
1
Brief Summary
This study is conducted on the evaluation of balance, physical activity, functional capacity and activities of daily living in frail elderly individuals with COPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2022
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
December 15, 2022
CompletedFirst Submitted
Initial submission to the registry
March 29, 2023
CompletedFirst Posted
Study publicly available on registry
April 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2024
CompletedOctober 15, 2024
April 1, 2024
1.1 years
March 29, 2023
October 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Berg balance scale(BDO)
The Berg balance scale (BDO) is a scale with 14 instructions and a score of 0-4 for each instruction by observing the patient's performance. 0 points are given when the patient is unable to perform the activity at all, while 4 points are given when the patient completes the activity independently. The highest score is 56, with 0-20 points indicating a balance disorder, 21-40 points indicating the presence of an acceptable balance, and 41-56 points indicating the presence of a good balance.
eight months
Two-minute walk Test
It is recommended that the area where the test will be performed is a corridor with a flat and hard floor of 30 meters long. The goal is to walk the maximum distance he can walk in 2 minutes if he has a helper device he uses. If you have shortness of breath or fatigue, you are told to slow down and stop and then start again when you feel ready.
eight months
Physical activity scale for the elderly (PASE)
The survey assesses the physical activity of older individuals over the past week and includes components of leisure, housework, and work-related physical activity. Never, rarely (1-2 days/week), sometimes (3-4 days/week) and often (5-7 days/week), while the duration of activities is classified as: Less than 1 hours, 1-2 hours to 2-4 hours and more than 4 hours.
eight months
Saint George Respiratory Survey
A test that assesses health-related quality of life specific to individuals with respiratory diseases. questions 50 items divided into 3 areas: symptoms (8 items), activities (16 items), effects of the disease (26 items). The 3 sections of the test are scored separately and the total score is calculated. The scores vary from 0-100-0. A score of zero indicates normal and a score of 100 indicates the worst state of health.
eight months
Modified Medical Research Council scale(MMRC)
The MMRC (modified Medical Research Council scale) is a scale scored between 0 and 4 based on various factors that produce a dyspnea sensation. Zero points only shorten my breath during heavy exercise; 4 points I can't leave the house because of my shortness of breath or I have shortness of breath while getting dressed and undressed
eight months
Frail fragility scale
Proven to be an effective method of vulnerability detection. The patient's fatigue status, resistance, mobility, weight loss and other diseases were questioned and allowed to evaluate. The FRAIL scale, which consists of 5 items, scores 0 1-2 or 1 based on the patients' response and is evaluated as non-frail, 0 points pre-frail and \>2 points fragile.
eight months
Secondary Outcomes (5)
Breathing function test
eight months
Prisma-7 Vulnerability scale
eight months
hand dynamometer
eight months
digital hand dynamometer
eight months
Fatigue Severity Scale
eight months
Study Arms (2)
Fragile elderly individuals with COPD
Patient evaluation form and socio-demographic form of all individuals participating in the study. properties will be questioned.To assess pulmonary functions at the assessment stage for all individuals pulmonary function test,Modified Medical Questionnaire to assess dyspnea research Council, to assess health-related quality of life, Saint George Respiratory Two Minute Walk Test to assess exercise capacity, frailty Frail fragility scale to detect fragility, Prisma-7 Vulnerability scale to assess fragility The scale is Pase to assess physical activity, Berg balance to assess balance. scale, digital hand dynamometer to evaluate quadriceps muscle strength, hand grip strength hand dynamometer to assess fatigue levels Fatigue Severity Scale will be used.
Non-fragile elderly individuals with COPD
Patient evaluation form and socio-demographic form of all individuals participating in the study. properties will be questioned.To assess pulmonary functions at the assessment stage for all individuals pulmonary function test,Modified Medical Questionnaire to assess dyspnea research Council, to assess health-related quality of life, Saint George Respiratory Two Minute Walk Test to assess exercise capacity, frailty Frail fragility scale to detect fragility, Prisma-7 Vulnerability scale to assess fragility The scale is Pase to assess physical activity, Berg balance to assess balance. scale, digital hand dynamometer to evaluate quadriceps muscle strength, hand grip strength hand dynamometer to assess fatigue levels Fatigue Severity Scale will be used.
Interventions
Modified Medical research Council , Saint George Respiratory Two Minute Walk Test,Frail fragility scale ,Prisma-7 Vulnerability scale,Pase,Berg balance scale,manual muscle test,quadriceps muscle strength, hand dynamometer,Fatigue Severity Scale
Eligibility Criteria
Elderly individuals aged 65-84 years diagnosed with COPD who are frail or non-fragile.
You may qualify if:
- Being diagnosed with COPD according to the Gold criteria
- Be over 65 years old
- Volunteering to participate in the study
- Not having mental and communication problems that prevent filling out the questionnaires to be used in the research.
- Not having an attack in the last 2 months
You may not qualify if:
- Being in a COPD exacerbation process
- Having been diagnosed with a physical and mental illness
- Having unstable COPD
- Unstabile angina, previous Myocardial Infractus, uncontrolled hypertension, cancer, with functional limitations concomitant neurological or musculoskeletal disorders
- Currently addicted to alcohol or drugs
- Having severe vision and hearing problems
- Have had major surgery in the last few months
- History of recurrent significant clinical infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kirikkale High Specialization Hospital
Kırıkkale, Merkez, 71100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yasemin Köse
Master of Science student
- PRINCIPAL INVESTIGATOR
Döndü Nur Keskin
Master of Science student
- PRINCIPAL INVESTIGATOR
İlayda Karabayır
Master of Science student
- STUDY DIRECTOR
Meral Sertel
Associate professor lecturer
- PRINCIPAL INVESTIGATOR
Selma Demir
Specialist doctor
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 8 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
March 29, 2023
First Posted
April 13, 2023
Study Start
December 15, 2022
Primary Completion
January 15, 2024
Study Completion
May 15, 2024
Last Updated
October 15, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share