Chronic Obstructive Pulmonary DiseaseNCT04627935
The Effect of Foot Deformities on Physical Activity, Fatigue Level and Quality of Life in Elderly COPD Patients
An observational study of Chronic Obstructive Pulmonary Disease and Foot Deformities, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of changes in foot structure on physical activity level, fatigue and quality of life in COPD patients. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Foot Deformities, Quality of Life
- What is being tested?
- The COPD Assessment Test, Navicular Drop Test and International Physical Activity Questionnaires (IPAQ)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 30 Dec 2021
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: 77 COPD patients, over 60 years of age
Who may be able to join
- Confirmed diagnosis of COPD
- Age over 60
Who cannot join
- Having an orthopedic or neurological disorder that affects the walking pattern
- Having a peripheral vascular disease
- Being diagnosed with Diabetes Mellitus
- Having systemic diseases such as arthritis
- Having a previous history of foot-ankle fractures
- Having a dermatological disease (fungal and bacterial infection etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Saglık Bilimleri University
Istanbul
Nilufer Kablan, Asst. Prof, 05067638556, niluferkablan@yahoo.com
Ayca Evkaya Acar, Res. Asst., 05544263263, ayca.evkaya@gmail.com
About this study
The aim of this study is to investigate the effects of changes in foot structure on physical activity level, fatigue and quality of life in COPD patients.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is usually a progressive disease associated with the increased chronic inflammatory response of the airways and lungs to the toxic effects of harmful gases and particles. It causes pathological changes such as increased secretion production in the airways, epithelial changes, inflammation, smooth muscle hypertrophy, and hyperplasia in the submucosal glands. Hyperinflammation in the lungs results in muscle atrophy, shortening of the respiratory muscles, and increased respiratory workload. On the other hand, the increase in pro-inflammatory plasma cytokine levels seen in the systemic circulation causes oxidative stress, leading to the development of musculoskeletal system disorders and a decrease in functional capacity. Pulmonary dysfunction and increased dyspnea lead to a decrease in physical condition, physical exercise tolerance, and activity, while the decrease in muscle mass results in atrophy in the peripheral extremities.
Age and gender are cited as major risk factors for COPD. Therefore, lower extremity atrophy, which is seen in peripheral extremities and increases with aging, causes foot dysfunctions. Considering that the ability of elderly people to maintain their independence is related to a good level of consciousness and ongoing ambulation, and the frequency of foot problems seen in elderly people is approximately twice as high as the general population, foot problems seen in elderly individuals are very important for this group. In particular, the decrease in foot mobility and the fall of the medial longitudinal arch negatively affect the absorption of shocks during heel strike and foot flat and the momentum of the trunk forward. This situation may result in the expenditure of energy above normal and deterioration of balance while ensuring the proper transfer of body weight. All of these cause early fatigue and a decrease in the quality of life in the individual. In the literature, foot deformities in elderly healthy individuals and the parameters these deformities will affect people are stated. However, there is no study examining the effects of foot deformities on physical activity, fatigue, and quality of life in elderly COPD patients.
- Conditions
- Chronic Obstructive Pulmonary Disease, Foot Deformities, Quality of Life, Activity, Motor, Fatigue
- Being tested
- The COPD Assessment Test, Navicular Drop Test, International Physical Activity Questionnaires (IPAQ), COPD and Asthma Fatigue Scale (CAFS), Saint George Respiratory Questionnaire
- Keywords
- Chronic Obstructive Pulmonary Disease, Foot deformities, quality of life, physical activity, fatigue, geriatric patient
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Foot Deformities, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The COPD Assessment TestBehavioural
Used to assess symptoms in COPD patients.
Navicular Drop TestDiagnostic test
It is the test used to measure the amount of pronation in the foot.
International Physical Activity Questionnaires (IPAQ)Behavioural
The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.
COPD and Asthma Fatigue Scale (CAFS)Behavioural
CAFS is a comprehensive, brief, patient-centered questionnaire developed to capture fatigue experienced by patients with asthma or COPD.
Saint George Respiratory QuestionnaireBehavioural
Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Patients with a diagnosis of COPD aged over 60 years Receives: Behavioral: The COPD Assessment Test; Diagnostic Test: Navicular Drop Test; Behavioral: International Physical Activity Questionnaires (IPAQ); Behavioral: COPD and Asthma Fatigue Scale (CAFS); Behavioral: Saint George Respiratory Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Navicular Drop Test
It is the test used to measure the amount of pronation in the foot.
Measured: Day 0
Secondary outcomes (4)
The COPD Assessment Test
Used to assess symptoms in COPD patients.
Measured: Day 0
International Physical Activity Questionnaires (IPAQ)
The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.
Measured: Day 0
COPD and Asthma Fatigue Scale (CAFS)
CAFS is a comprehensive, brief, patient-centered questionnaire developed to capture fatigue experienced by patients with asthma or COPD.
Measured: Day 0
Saint George Respiratory Questionnaire
Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Mar 2021 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nilufer Kablan, Asst. Prof., Study director, Istanbul Sağlık Bilimleri UniversityAyca Evkaya Acar, Res. Asst., Principal investigator, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627935
- Sponsor's protocol ID
- 09.2020.766
- Status last verified
- Nov 2020
- First submitted
- 8 Nov 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jones PW, Adamek L, Nadeau G, Banik N. Comparisons of health status scores with MRC grades in COPD: implications for the GOLD 2011 classification. Eur Respir J. 2013 Sep;42(3):647-54. doi: 10.1183/09031936.00125612. Epub 2012 Dec 20.
PubMed 23258783de Sa RB, Pessoa MF, Cavalcanti AGL, Campos SL, Amorim C, Dornelas de Andrade A. Immediate effects of respiratory muscle stretching on chest wall kinematics and electromyography in COPD patients. Respir Physiol Neurobiol. 2017 Aug;242:1-7. doi: 10.1016/j.resp.2017.03.002. Epub 2017 Mar 10.
PubMed 28286249Sun KS, Lin MS, Chen YJ, Chen YY, Chen SC, Chen W. Is asymptomatic peripheral arterial disease associated with walking endurance in patients with COPD? Int J Chron Obstruct Pulmon Dis. 2015 Jul 29;10:1487-92. doi: 10.2147/COPD.S85430. eCollection 2015.
PubMed 26251588Atasever A, Erdinc E. [Quality of life in COPD]. Tuberk Toraks. 2003;51(4):446-55. Turkish.
PubMed 15143396Theander K, Unosson M. Fatigue in patients with chronic obstructive pulmonary disease. J Adv Nurs. 2004 Jan;45(2):172-7. doi: 10.1046/j.1365-2648.2003.02878.x.
PubMed 14706002
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Deformities on Physical Activity, Fatigue Level and Quality of Life in Elderly COPD Patients
- ClinicalTrials.gov ID
- NCT04627935
- Acronym / sponsor ID
- 09.2020.766
- Conditions
- Chronic Obstructive Pulmonary Disease, Foot Deformities, Quality of Life, Activity, Motor, Fatigue
- Keywords
- Chronic Obstructive Pulmonary Disease, Foot deformities, quality of life, physical activity, fatigue, geriatric patient
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 13 Nov 2020 (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 aim of this study is to investigate the effects of changes in foot structure on physical activity level, fatigue and quality of life in COPD patients.
Detailed description
Chronic obstructive pulmonary disease (COPD) is usually a progressive disease associated with the increased chronic inflammatory response of the airways and lungs to the toxic effects of harmful gases and particles. It causes pathological changes such as increased secretion production in the airways, epithelial changes, inflammation, smooth muscle hypertrophy, and hyperplasia in the submucosal glands. Hyperinflammation in the lungs results in muscle atrophy, shortening of the respiratory muscles, and increased respiratory workload. On the other hand, the increase in pro-inflammatory plasma cytokine levels seen in the systemic circulation causes oxidative stress, leading to the development of musculoskeletal system disorders and a decrease in functional capacity. Pulmonary dysfunction and increased dyspnea lead to a decrease in physical condition, physical exercise tolerance, and activity, while the decrease in muscle mass results in atrophy in the peripheral extremities.
Age and gender are cited as major risk factors for COPD. Therefore, lower extremity atrophy, which is seen in peripheral extremities and increases with aging, causes foot dysfunctions. Considering that the ability of elderly people to maintain their independence is related to a good level of consciousness and ongoing ambulation, and the frequency of foot problems seen in elderly people is approximately twice as high as the general population, foot problems seen in elderly individuals are very important for this group. In particular, the decrease in foot mobility and the fall of the medial longitudinal arch negatively affect the absorption of shocks during heel strike and foot flat and the momentum of the trunk forward. This situation may result in the expenditure of energy above normal and deterioration of balance while ensuring the proper transfer of body weight. All of these cause early fatigue and a decrease in the quality of life in the individual. In the literature, foot deformities in elderly healthy individuals and the parameters these deformities will affect people are stated. However, there is no study examining the effects of foot deformities on physical activity, fatigue, and quality of life in elderly COPD patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | Behavioral: The COPD Assessment Test, Diagnostic Test: Navicular Drop Test, Behavioral: International Physical Activity Questionnaires (IPAQ), Behavioral: COPD and Asthma Fatigue Scale (CAFS), Behavioral: Saint George Respiratory QuestionnairePatients with a diagnosis of COPD aged over 60 years |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 77 COPD patients, over 60 years of age
Key inclusion criteria (2 listed)
- Confirmed diagnosis of COPD
- Age over 60
Key exclusion criteria (6 listed)
- Having an orthopedic or neurological disorder that affects the walking pattern
- Having a peripheral vascular disease
- Being diagnosed with Diabetes Mellitus
- Having systemic diseases such as arthritis
- Having a previous history of foot-ankle fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The COPD Assessment TestUsed to assess symptoms in COPD patients. | Behavioural | COPD patients |
| Navicular Drop TestIt is the test used to measure the amount of pronation in the foot. | Diagnostic test | COPD patients |
| International Physical Activity Questionnaires (IPAQ)The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity. | Behavioural | COPD patients |
| COPD and Asthma Fatigue Scale (CAFS)CAFS is a comprehensive, brief, patient-centered questionnaire developed to capture fatigue experienced by patients with asthma or COPD. | Behavioural | COPD patients |
| Saint George Respiratory QuestionnaireDisease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. | Behavioural | COPD patients |
Primary outcome
Navicular Drop Test
Time frame: Day 0
It is the test used to measure the amount of pronation in the foot.
4 secondary outcomes
The COPD Assessment Test
Time frame: Day 0
International Physical Activity Questionnaires (IPAQ)
Time frame: Day 0
COPD and Asthma Fatigue Scale (CAFS)
Time frame: Day 0
Saint George Respiratory Questionnaire
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Background: PubMed 23258783Jones PW, Adamek L, Nadeau G, Banik N. Comparisons of health status scores with MRC grades in COPD: implications for the GOLD 2011 classification. Eur Respir J. 2013 Sep;42(3):647-54. doi: 10.1183/09031936.00125612. Epub 2012 Dec 20.
- Background: PubMed 28286249de Sa RB, Pessoa MF, Cavalcanti AGL, Campos SL, Amorim C, Dornelas de Andrade A. Immediate effects of respiratory muscle stretching on chest wall kinematics and electromyography in COPD patients. Respir Physiol Neurobiol. 2017 Aug;242:1-7. doi: 10.1016/j.resp.2017.03.002. Epub 2017 Mar 10.
- Background: PubMed 26251588Sun KS, Lin MS, Chen YJ, Chen YY, Chen SC, Chen W. Is asymptomatic peripheral arterial disease associated with walking endurance in patients with COPD? Int J Chron Obstruct Pulmon Dis. 2015 Jul 29;10:1487-92. doi: 10.2147/COPD.S85430. eCollection 2015.
- Background: PubMed 15143396Atasever A, Erdinc E. [Quality of life in COPD]. Tuberk Toraks. 2003;51(4):446-55. Turkish.
- Background: PubMed 14706002Theander K, Unosson M. Fatigue in patients with chronic obstructive pulmonary disease. J Adv Nurs. 2004 Jan;45(2):172-7. doi: 10.1046/j.1365-2648.2003.02878.x.
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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.
Nilufer Kablan, Asst. Prof. study director
Istanbul Sağlık Bilimleri University
Ayca Evkaya Acar, Res. Asst. principal investigator
Maltepe 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 Chronic Obstructive Pulmonary Disease and Foot Deformities, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nilufer Kablan, Asst. Prof. (05067638556, niluferkablan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Navicular Drop Test (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04627935, which also lists 5 linked publications.
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 13 Nov 2020.