ClinicalTrials.gg
Status unknownNCT04627935Updated Nov 13, 2020

The Effect of Foot Deformities on Physical Activity, Fatigue Level and Quality of Life in Elderly COPD Patients

An observational study in Chronic Obstructive Pulmonary Disease, Foot Deformities and Quality of Life, sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Status unknown at 1 site in Turkey. Open to participants aged 65 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-11-13.

Sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
77
Ages
65 Years to 100 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • 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
03

In context

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

This study's planned enrollment of 77 is below the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey is the lead sponsor of 108 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

77 COPD patients, over 60 years of age

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Confirmed diagnosis of
  • Age over 60

Exclusion criteria

Exclusion Criteria:

  • 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.)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
77 participants (estimated)
Patient registry
No

Groups and cohorts

  • COPD patients

    Patients with a diagnosis of COPD aged over 60 years

    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

Interventions

  • BehavioralThe COPD Assessment Test

    Used to assess symptoms in COPD patients.

  • Diagnostic testNavicular Drop Test

    It is the test used to measure the amount of pronation in the foot.

  • BehavioralInternational 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.

  • BehavioralCOPD and Asthma Fatigue Scale (CAFS)

    CAFS is a comprehensive, brief, patient-centered questionnaire developed to capture fatigue experienced by patients with asthma or COPD.

  • BehavioralSaint 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.

06

What researchers measure

Primary outcomes

  1. Navicular Drop Test

    It is the test used to measure the amount of pronation in the foot.

    Time frame: Day 0

Secondary outcomes

  1. The COPD Assessment Test

    Used to assess symptoms in COPD patients.

    Time frame: Day 0

  2. 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.

    Time frame: Day 0

  3. 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.

    Time frame: Day 0

  4. 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.

    Time frame: Day 0

07

Study locations

1 site
  • Istanbul Saglık Bilimleri University
    Istanbul, Turkey
08

References and documents

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 23258783 ↗
  • de 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 28286249 ↗
  • Sun 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 26251588 ↗
  • Atasever A, Erdinc E. [Quality of life in COPD]. Tuberk Toraks. 2003;51(4):446-55. Turkish. PubMed 15143396 ↗
  • Theander 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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2021; primary completion for Sep 2021, 6 months later.

Of 466 non-industry observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 64. This study's planned 6 months is below that.

Counting every sponsor, half of 586 studies reached it within 26 months; a quarter within 14 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2020
First posted
Nov 13, 2020
StartEst.
Mar 1, 2021
Primary completionEst.
Sep 1, 2021
CompletionEst.
Dec 30, 2021
Last update
Nov 13, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04627935
Responsible party
Sponsor
First posted
Nov 13, 2020
Start date
Mar 1, 2021 (estimated)
Primary completion
Sep 1, 2021 (estimated)
Completion
Dec 30, 2021 (estimated)
Last update
Nov 13, 2020

Study contacts

Nilufer Kablan, Asst. Prof.
Contact
niluferkablan@yahoo.com
05067638556
Ayca Evkaya Acar, Res. Asst.
Contact
ayca.evkaya@gmail.com
05544263263
Nilufer Kablan, Asst. Prof.
study director · Istanbul Sağlık Bilimleri University
Ayca Evkaya Acar, Res. Asst.
principal investigator · Maltepe University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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