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

This study is conducted on the evaluation of balance, physical activity, functional capacity and activities of daily living in frail elderly individuals with COPD.

Study Overview

• Status: Recruiting
• Conditions: COPD (Chronic Obstructive Pulmonary Disease)
• Intervention / Treatment: Other: Evaluation

Detailed Description

Patient evaluation form and socio-demographic form of all individuals participating in the study. Characteristics will be questioned: Name-surname, address, telephone, age, gender, weight, height, body mass index, occupation, marital status, social security, any systemic other than COPD whether he has a disease, whether he has social security, whether he smokes, It will be questioned whether there is any other COPD patient in the family and whether there is pain. To assess pulmonary functions at the assessment stage for all individuals pulmonary function test to evaluate dyspnea Modified Medical Saint George Respiratory Research Council to assess health-related quality of life Two Minute Walk Test to assess exercise capacity, frailty Frail fragility scale to detect frailty, Prisma-7 Vulnerability scale to assess fragility The scale was Pase to assess physical activity, Berg Balance to assess balance scale, digital hand dynamometer to assess quadriceps muscle strength, hand grip hand dynamometer to assess strength, fatigue levels Fatigue Severity Scale will be used to evaluate.

• Study Type: Observational
• Enrollment (Anticipated): 54

Contacts and Locations

• Study Contact: Name: Yasemin Köse; Phone Number: +90 +905464682828; Email: koseyasemin9928@gmail.com
• Study Contact Backup: Name: Döndü Nur Keskin; Phone Number: +90 +905434833113; Email: nurkskn-99@hotmail.com

Study Locations

• Turkey
  • Merkez
    • Kırıkkale, Merkez, Turkey, 71100
      • Recruiting
      • Kirikkale High Specialization Hospital
      • Contact: Selma Demir; Phone Number: +905054895758

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Elderly individuals aged 65-84 years diagnosed with COPD who are frail or non-fragile.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Evaluation; 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
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.	Other: Evaluation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breathing function test	Spirometry shows the maximum volume of air expelled by the challenging expiration (challenging vital capacity, FVC) from the maximum inspiration point and the volume of air expelled in the first second of this manoeuvre (1. The challenging expiration volume per second, FEV 1) should be measured and these two measurement ratios (FEV 1/FVC) should be calculated. Patients with COPD typically have both FEV 1 and FVC low. When FEV 1/FVC < 70%, the postbronchodilator indicates the presence of a non-fully reversible airflow limitation when FEV 1 < 80% of what is expected.	eight months
Prisma-7 Vulnerability scale	The PRISMA-7 vulnerability scale is a seven-question survey recommended by the British Geriatric Association as a first-degree screening test. The questions are answered in a yes/no way.	eight months
hand dynamometer	During the test, the patient sits in a sitting position in shoulder adduction, elbow in 90° flexion, forearm in neutral position, and measurements are performed three repetitions for the right and left sides. It is recorded in kg or pounds as a unit. The norm values for the measurement are 47-40 kg for men aged 20-69 years (2 kg less for the left hand) and 30-24 kg for women (1,5-2 kg less for the left hand).	eight months
digital hand dynamometer	For quadriceps strength measurement, the test is started when elderly people sit on a flat surface with their hips and knees in 90° flexion and feet in a free, unsupported position. During the test, the "make test" technique, which requires isometric contraction, is applied. All measurements are taken by the same researcher twice from both legs of the participants with the same hand.	eight months
Fatigue Severity Scale	Evaluates fatigue severity with 9 questions and scores are taken from 9 to 63 on the scale. Each question is scored between 0 (I do not agree at all) and 7 (I totally agree). A high score indicates increased fatigue intensity.	eight months

Collaborators and Investigators

• Sponsor: Kırıkkale University
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Anticipated): June 15, 2023
• Study Completion (Anticipated): July 15, 2023

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: geriatric; COPD (Chronic Obstructive Pulmonary Disease); fragility
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: KirikkaleUniversity771

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No