NCT05811832

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

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

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

December 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

March 29, 2023

Last Update Submit

October 10, 2024

Conditions

Keywords

COPD (Chronic Obstructive Pulmonary Disease)fragilitygeriatric

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.

Other: Evaluation

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

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

Fragile elderly individuals with COPDNon-fragile elderly individuals with COPD

Eligibility Criteria

Age65 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yasemin Köse

    Master of Science student

    PRINCIPAL INVESTIGATOR
  • Döndü Nur Keskin

    Master of Science student

    PRINCIPAL INVESTIGATOR
  • İlayda Karabayır

    Master of Science student

    PRINCIPAL INVESTIGATOR
  • Meral Sertel

    Associate professor lecturer

    STUDY DIRECTOR
  • Selma Demir

    Specialist doctor

    PRINCIPAL INVESTIGATOR

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

Locations