COPDNCT03840941
The Effect of Frailty on Balance, Activities of Daily, and Exercise Capacity in COPD
An observational study of COPD and Frailty, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The investigators aim to demonstrate whether balance, cognition and activities of daily living have changed in COPD patients with and without frailty. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 15 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who are diagnosed with COPD at Hacettepe University and who are referred to the Cardiopulmonary Rehabilitation Unit for physiotherapy also who are willing to participate in the study will be included in the study.
Who may be able to join
- COPD patients who have been clinically stable for the last four weeks and who have not undergone drug change for the last four weeks
- Being 55 years of age or older
- Accepted to participate in the study (Able and wililing to complete the informed consent process)
- Co-operate
- Patients with COPD who are ambulant without support or an assistive device
Who cannot join
- Neurological, cardiac or orthopedic diseases
- Other chronic diseases that may affect balance and walking
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
Ankara, Sihhiye, 06100
About this study
Official title: The Effect Of Frailty Level On Balance, Cognition And Activities Of Daily Living In COPD
The investigators aim to demonstrate whether balance, cognition and activities of daily living have changed in COPD patients with and without frailty.
Read the detailed description
COPD is a common, preventable and treatable disease characterized by progressive respiratory symptoms and airflow limitation. Frailty defines a clinical syndrome characterized by multiple system effects, leading to decreased functional reserve and increased sensitivity to dependence or mortality following minor stress events. Inflammation, lack of physical activity, reduced exercise efficiency and maximum oxygen uptake may contribute to the development of frailty in patients with COPD. Balance, cognition and activities of daily living are associated with COPD.
This study will evaluate the effect of frailty on balance, cognition and activities of daily living in patients with COPD.
- Keywords
- COPD, Frailty, Balance, Cognition, Activities of Daily Living
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Frail patients with COPD | No intervention | |
| Non-frail patients with COPD | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of The Frailty Will Be evaluated Using The Frailty Criteria by Fried
Frailty will be identified by the presence of three or more of the following criteria unintentional weight loss (10 Ibs in past year), weakness (grip strength), self-reported exhaustion, slow walking speed and low physical activity. Patients with three or more of the criteria present were classified as frail.
Measured: 1st Day
Balance Assessment Using Functional Reach Test
The Functional Reach Test measures how far patient can reach forward from a normal relaxed stance.
Measured: 1st Day
Cognition Using MoCA-Test
Cognitive function will be evaluated with the secreening tool the Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point screening tool.
Measured: 1st Day
Perform activities of daily living (ADL) will be evaluated using the Glittre ADL-test
Glittre ADL-test was designed specifically to assess the functional limitation in patients with COPD. Glittre ADL-test time will be considered the main outcome variable, and will be recorded in minutes (metric).
Measured: 1st Day
Secondary outcomes (4)
Exercise Capacity Using 6-Minute Walk Test
The standard protocol of the test is applied in a 30-meter continuous corridor. Standard instructions are given during testing.
Measured: 1st Day
Disease-Related Quality of Life Assessment
COPD evaluation test (CAT) was developed to help assess health status.
Measured: 1st Day
Respiratory Muscle Strength Assessment
Respiratory muscle strength will be evaluated by non-invasive methods by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
Measured: 1st Day
Shortness of Breath Assessment
Modified Medical Research Council (mMRC) dyspnea scale will be used to determine the shortness of breath severity.
Measured: 1st Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Mar 2018
- Primary completion15 Oct 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Inal-Ince, Hacettepe University
- Investigators
- Deniz Inal-Ince, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840941
- Sponsor's protocol ID
- GO 18/83-22
- Status last verified
- Nov 2023
- First submitted
- 12 Feb 2019
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Frailty Level On Balance, Cognition And Activities Of Daily Living In COPD
- ClinicalTrials.gov ID
- NCT03840941
- Acronym / sponsor ID
- GO 18/83-22
- Keywords
- COPD, Frailty, Balance, Cognition, Activities of Daily Living
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to demonstrate whether balance, cognition and activities of daily living have changed in COPD patients with and without frailty.
Detailed description
COPD is a common, preventable and treatable disease characterized by progressive respiratory symptoms and airflow limitation. Frailty defines a clinical syndrome characterized by multiple system effects, leading to decreased functional reserve and increased sensitivity to dependence or mortality following minor stress events. Inflammation, lack of physical activity, reduced exercise efficiency and maximum oxygen uptake may contribute to the development of frailty in patients with COPD. Balance, cognition and activities of daily living are associated with COPD.
This study will evaluate the effect of frailty on balance, cognition and activities of daily living in patients with COPD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frail patients with COPD | – | –No intervention |
| Non-frail patients with COPD | – | –No intervention |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who are diagnosed with COPD at Hacettepe University and who are referred to the Cardiopulmonary Rehabilitation Unit for physiotherapy also who are willing to participate in the study will be included in the study.
Key inclusion criteria (5 listed)
- COPD patients who have been clinically stable for the last four weeks and who have not undergone drug change for the last four weeks
- Being 55 years of age or older
- Accepted to participate in the study (Able and wililing to complete the informed consent process)
- Co-operate
- Patients with COPD who are ambulant without support or an assistive device
Key exclusion criteria (2 listed)
- Neurological, cardiac or orthopedic diseases
- Other chronic diseases that may affect balance and walking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of The Frailty Will Be evaluated Using The Frailty Criteria by Fried
Time frame: 1st Day
Frailty will be identified by the presence of three or more of the following criteria unintentional weight loss (10 Ibs in past year), weakness (grip strength), self-reported exhaustion, slow walking speed and low physical activity. Patients with three or more of the criteria present were classified as frail.
Balance Assessment Using Functional Reach Test
Time frame: 1st Day
The Functional Reach Test measures how far patient can reach forward from a normal relaxed stance.
Cognition Using MoCA-Test
Time frame: 1st Day
Cognitive function will be evaluated with the secreening tool the Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point screening tool.
Perform activities of daily living (ADL) will be evaluated using the Glittre ADL-test
Time frame: 1st Day
Glittre ADL-test was designed specifically to assess the functional limitation in patients with COPD. Glittre ADL-test time will be considered the main outcome variable, and will be recorded in minutes (metric).
4 secondary outcomes
Exercise Capacity Using 6-Minute Walk Test
Time frame: 1st Day
Disease-Related Quality of Life Assessment
Time frame: 1st Day
Respiratory Muscle Strength Assessment
Time frame: 1st Day
Shortness of Breath Assessment
Time frame: 1st Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deniz Inal-Ince, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Frailty, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of The Frailty Will Be evaluated Using The Frailty Criteria by Fried (time frame: 1st Day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.