Chronic Obstructive Pulmonary DiseaseNCT05110755
Correlation of Physical Activity and Respiratory Health in COPD Patient
An observational study of Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
COPD is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities, usually caused by significant exposure to noxious particles or gases. COPD is third leading cause of death worldwide. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 140 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2021to 1 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Researcher will visit selected hospital setting with questionnaire and Consent form. Consent form will be signed from patient prior to questionnaire. IPAQ Questionnaire will be given and briefly elaborated before filling. 6MVT and spirometry measurements will be taken after and documented.
Who may be able to join
- Smokers and Non- Smokers.
- Age between 18 to 60 years.
- Both Male and Female
Who cannot join
- Subjects with COPD Exacerbations
- Subjects with respiratory complication others than CPOD
- Bed bound subjects with CPOD
Trial locations and contacts
1 site in 1 country.
About this study
COPD is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities, usually caused by significant exposure to noxious particles or gases. COPD is third leading cause of death worldwide. "Ideal cardiovascular health," a set of factors, including several directly along the causal pathway of transitions from health to disease, that protect against the development of cardiac disease. Working definition of respiratory health are the dual concepts of pulmonary reserve, as reflected by peak lung function in young adulthood, and susceptibility, as reflected by risk for future accelerated decline in lung function after the attainment of this peak. There is relationship between physical activity, disease severity, health status and prognosis in patients with COPD. Common pulmonary function tests include spirometry, lung volumes, and diffusing capacity for carbon monoxide (DLCO). Spirometry assesses airflow limitation. Diffusing capacity for carbon monoxide provides information on the health of alveolar-capillary membrane.
This study will be cross-sectional correlational study. It will find correlation between person's physical activity and respiratory health. IPAQ and 6MIN walk test will be used as measuring tools of physical activity and FEV1 and TLV for estimating respiratory health. Spirometer will be used to measure respiratory health. Data will be collected from different hospital settings and analysed using SPSS software. All ethical considerations will be followed.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a heterogeneous and multisystemic disease with progressive increasing morbidity and mortality. Chronic obstructive pulmonary disease (COPD) is a deteriorating respiratory disease with some extrapulmonary effects that contribute to disease severity in patient. The etiology, in general, involves exposure to external noxious particles or gases. In the Western world this is particularly a result of (cigarette) smoking and in the non-Western world it is mainly a result of indoor cooking. COPD pathology is driven by chronic inflammation, which continues to be observed after stopping smoking, even after ⩾1 year. The combination of the exposure and inflammation leads to lung tissue damage, resulting in remodeling of the lung.Global Burden of Disease programme in 2010 identified chronic obstructive pulmonary disease (COPD) as the third leading cause of death worldwide up from 4th in 1990. This high mortality due to COPD is caused due to smoking and rapidly aging population. China alone contributed to about one-third (0.9million/year) of all deaths from COPD worldwide. Within China, the prevalence of COPD varies substantially by region and death rates attributed to COPD are twofold greater in South-West compared with North-East regions for reasons that are not fully understood.
Physical activity in terms of body movements, walking time and standing time has been shown to be reduced in patients with severe COPD. However, it is currently unknown at which clinical stage of the disease limitations of physical activity are first displayed. Furthermore, the relationships between physical activity and clinical characteristics reflecting the disease severity, such as the degree of airway obstruction, distance walked in 6 min, self-reported grade of dyspnea and clinical stages of COPD, need to be investigated as, to date, data are inconclusive or have never been evaluated. For example, some studies have found substantial correlations between airway obstruction and physical activity, while others found no or only loose relationships. Previous studies indicate that the 6-min walking distance (6MWD) might best reflect physical activity, while a recent study found airway obstruction to correlate with physical activity better than 6MWD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Respiratory Health, Pulmonary Function, Physical Activity, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire (IPAQ)
IPAQ Urdu version will be used to document Physical Activity
Measured: Day 1
6 minute Walk Test (6MWT)
6 Minute Walk Test is used to measure cardiovascular health
Measured: Day 1
Forced Expiratory Volume 1 Sec
Forced Expiratory Volume 1 Sec is used to measure respiratory health
Measured: Day 1
Forced vital capacity (FVC)
Forced vital capacity (FVC) is used to measure respiratory health
Measured: Day 1
FEV1/FVC
FEV1/FVC ratio is used to measure respiratory health
Measured: Day 1
Peak expiratory flow (PEF)
Peak expiratory flow (PEF) is used to measure respiratory health
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Apr 2021
- Primary completion1 Nov 2021
- Study completion1 Dec 2021
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.
- More trials run by Riphah International 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danish Hassan, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110755
- Sponsor's protocol ID
- REC/Lhr/0319 Misdaq Batool
- Status last verified
- Apr 2022
- First submitted
- 17 Aug 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bacharier LB, Beigelman A, Calatroni A, Jackson DJ, Gergen PJ, O'Connor GT, Kattan M, Wood RA, Sandel MT, Lynch SV, Fujimura KE, Fadrosh DW, Santee CA, Boushey H, Visness CM, Gern JE; NIAID sponsored Inner-City Asthma Consortium. Longitudinal Phenotypes of Respiratory Health in a High-Risk Urban Birth Cohort. Am J Respir Crit Care Med. 2019 Jan 1;199(1):71-82. doi: 10.1164/rccm.201801-0190OC.
PubMed 30079758Kurmi OP, Davis KJ, Hubert Lam KB, Guo Y, Vaucher J, Bennett D, Wang J, Bian Z, Du H, Li L, Clarke R, Chen Z. Patterns and management of chronic obstructive pulmonary disease in urban and rural China: a community-based survey of 25 000 adults across 10 regions. BMJ Open Respir Res. 2018 Feb 19;5(1):e000267. doi: 10.1136/bmjresp-2017-000267. eCollection 2018.
PubMed 29531747Aghilinejad M, Kabir-Mokamelkhah E, Nassiri-Kashani MH, Bahrami-Ahmadi A, Dehghani A. Assessment of Pulmonary Function Parameters and Respiratory Symptoms in Shipyard Workers of Asaluyeh City, Iran. Tanaffos. 2016;15(2):108-111.
PubMed 27904543Mesquita R, Spina G, Pitta F, Donaire-Gonzalez D, Deering BM, Patel MS, Mitchell KE, Alison J, van Gestel AJ, Zogg S, Gagnon P, Abascal-Bolado B, Vagaggini B, Garcia-Aymerich J, Jenkins SC, Romme EA, Kon SS, Albert PS, Waschki B, Shrikrishna D, Singh SJ, Hopkinson NS, Miedinger D, Benzo RP, Maltais F, Paggiaro P, McKeough ZJ, Polkey MI, Hill K, Man WD, Clarenbach CF, Hernandes NA, Savi D, Wootton S, Furlanetto KC, Cindy Ng LW, Vaes AW, Jenkins C, Eastwood PR, Jarreta D, Kirsten A, Brooks D, Hillman DR, Sant'Anna T, Meijer K, Durr S, Rutten EP, Kohler M, Probst VS, Tal-Singer R, Gil EG, den Brinker AC, Leuppi JD, Calverley PM, Smeenk FW, Costello RW, Gramm M, Goldstein R, Groenen MT, Magnussen H, Wouters EF, ZuWallack RL, Amft O, Watz H, Spruit MA. Physical activity patterns and clusters in 1001 patients with COPD. Chron Respir Dis. 2017 Aug;14(3):256-269. doi: 10.1177/1479972316687207. Epub 2017 Feb 24.
PubMed 28774199Rocha FR, Bruggemann AK, Francisco DS, Medeiros CS, Rosal D, Paulin E. Diaphragmatic mobility: relationship with lung function, respiratory muscle strength, dyspnea, and physical activity in daily life in patients with COPD. J Bras Pneumol. 2017 Jan-Feb;43(1):32-37. doi: 10.1590/S1806-37562016000000097.
PubMed 28380186
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Physical Activity and Respiratory Health in COPD Patient
- ClinicalTrials.gov ID
- NCT05110755
- Acronym / sponsor ID
- REC/Lhr/0319 Misdaq Batool
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Respiratory Health, Pulmonary Function, Physical Activity, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 8 Nov 2021 (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.
COPD is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities, usually caused by significant exposure to noxious particles or gases. COPD is third leading cause of death worldwide. "Ideal cardiovascular health," a set of factors, including several directly along the causal pathway of transitions from health to disease, that protect against the development of cardiac disease. Working definition of respiratory health are the dual concepts of pulmonary reserve, as reflected by peak lung function in young adulthood, and susceptibility, as reflected by risk for future accelerated decline in lung function after the attainment of this peak. There is relationship between physical activity, disease severity, health status and prognosis in patients with COPD. Common pulmonary function tests include spirometry, lung volumes, and diffusing capacity for carbon monoxide (DLCO). Spirometry assesses airflow limitation. Diffusing capacity for carbon monoxide provides information on the health of alveolar-capillary membrane.
This study will be cross-sectional correlational study. It will find correlation between person's physical activity and respiratory health. IPAQ and 6MIN walk test will be used as measuring tools of physical activity and FEV1 and TLV for estimating respiratory health. Spirometer will be used to measure respiratory health. Data will be collected from different hospital settings and analysed using SPSS software. All ethical considerations will be followed.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a heterogeneous and multisystemic disease with progressive increasing morbidity and mortality. Chronic obstructive pulmonary disease (COPD) is a deteriorating respiratory disease with some extrapulmonary effects that contribute to disease severity in patient. The etiology, in general, involves exposure to external noxious particles or gases. In the Western world this is particularly a result of (cigarette) smoking and in the non-Western world it is mainly a result of indoor cooking. COPD pathology is driven by chronic inflammation, which continues to be observed after stopping smoking, even after ⩾1 year. The combination of the exposure and inflammation leads to lung tissue damage, resulting in remodeling of the lung.Global Burden of Disease programme in 2010 identified chronic obstructive pulmonary disease (COPD) as the third leading cause of death worldwide up from 4th in 1990. This high mortality due to COPD is caused due to smoking and rapidly aging population. China alone contributed to about one-third (0.9million/year) of all deaths from COPD worldwide. Within China, the prevalence of COPD varies substantially by region and death rates attributed to COPD are twofold greater in South-West compared with North-East regions for reasons that are not fully understood.
Physical activity in terms of body movements, walking time and standing time has been shown to be reduced in patients with severe COPD. However, it is currently unknown at which clinical stage of the disease limitations of physical activity are first displayed. Furthermore, the relationships between physical activity and clinical characteristics reflecting the disease severity, such as the degree of airway obstruction, distance walked in 6 min, self-reported grade of dyspnea and clinical stages of COPD, need to be investigated as, to date, data are inconclusive or have never been evaluated. For example, some studies have found substantial correlations between airway obstruction and physical activity, while others found no or only loose relationships. Previous studies indicate that the 6-min walking distance (6MWD) might best reflect physical activity, while a recent study found airway obstruction to correlate with physical activity better than 6MWD.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Researcher will visit selected hospital setting with questionnaire and Consent form. Consent form will be signed from patient prior to questionnaire. IPAQ Questionnaire will be given and briefly elaborated before filling. 6MVT and spirometry measurements will be taken after and documented.
Key inclusion criteria (3 listed)
- Smokers and Non- Smokers.
- Age between 18 to 60 years.
- Both Male and Female
Key exclusion criteria (3 listed)
- Subjects with COPD Exacerbations
- Subjects with respiratory complication others than CPOD
- Bed bound subjects with CPOD
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
International Physical Activity Questionnaire (IPAQ)
Time frame: Day 1
IPAQ Urdu version will be used to document Physical Activity
6 minute Walk Test (6MWT)
Time frame: Day 1
6 Minute Walk Test is used to measure cardiovascular health
Forced Expiratory Volume 1 Sec
Time frame: Day 1
Forced Expiratory Volume 1 Sec is used to measure respiratory health
Forced vital capacity (FVC)
Time frame: Day 1
Forced vital capacity (FVC) is used to measure respiratory health
FEV1/FVC
Time frame: Day 1
FEV1/FVC ratio is used to measure respiratory health
Peak expiratory flow (PEF)
Time frame: Day 1
Peak expiratory flow (PEF) is used to measure respiratory health
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 6 Apr 2022.
- Background: PubMed 30079758Bacharier LB, Beigelman A, Calatroni A, Jackson DJ, Gergen PJ, O'Connor GT, Kattan M, Wood RA, Sandel MT, Lynch SV, Fujimura KE, Fadrosh DW, Santee CA, Boushey H, Visness CM, Gern JE; NIAID sponsored Inner-City Asthma Consortium. Longitudinal Phenotypes of Respiratory Health in a High-Risk Urban Birth Cohort. Am J Respir Crit Care Med. 2019 Jan 1;199(1):71-82. doi: 10.1164/rccm.201801-0190OC.
- Background: PubMed 29531747Kurmi OP, Davis KJ, Hubert Lam KB, Guo Y, Vaucher J, Bennett D, Wang J, Bian Z, Du H, Li L, Clarke R, Chen Z. Patterns and management of chronic obstructive pulmonary disease in urban and rural China: a community-based survey of 25 000 adults across 10 regions. BMJ Open Respir Res. 2018 Feb 19;5(1):e000267. doi: 10.1136/bmjresp-2017-000267. eCollection 2018.
- Background: PubMed 27904543Aghilinejad M, Kabir-Mokamelkhah E, Nassiri-Kashani MH, Bahrami-Ahmadi A, Dehghani A. Assessment of Pulmonary Function Parameters and Respiratory Symptoms in Shipyard Workers of Asaluyeh City, Iran. Tanaffos. 2016;15(2):108-111.
- Background: PubMed 28774199Mesquita R, Spina G, Pitta F, Donaire-Gonzalez D, Deering BM, Patel MS, Mitchell KE, Alison J, van Gestel AJ, Zogg S, Gagnon P, Abascal-Bolado B, Vagaggini B, Garcia-Aymerich J, Jenkins SC, Romme EA, Kon SS, Albert PS, Waschki B, Shrikrishna D, Singh SJ, Hopkinson NS, Miedinger D, Benzo RP, Maltais F, Paggiaro P, McKeough ZJ, Polkey MI, Hill K, Man WD, Clarenbach CF, Hernandes NA, Savi D, Wootton S, Furlanetto KC, Cindy Ng LW, Vaes AW, Jenkins C, Eastwood PR, Jarreta D, Kirsten A, Brooks D, Hillman DR, Sant'Anna T, Meijer K, Durr S, Rutten EP, Kohler M, Probst VS, Tal-Singer R, Gil EG, den Brinker AC, Leuppi JD, Calverley PM, Smeenk FW, Costello RW, Gramm M, Goldstein R, Groenen MT, Magnussen H, Wouters EF, ZuWallack RL, Amft O, Watz H, Spruit MA. Physical activity patterns and clusters in 1001 patients with COPD. Chron Respir Dis. 2017 Aug;14(3):256-269. doi: 10.1177/1479972316687207. Epub 2017 Feb 24.
- Background: PubMed 28380186Rocha FR, Bruggemann AK, Francisco DS, Medeiros CS, Rosal D, Paulin E. Diaphragmatic mobility: relationship with lung function, respiratory muscle strength, dyspnea, and physical activity in daily life in patients with COPD. J Bras Pneumol. 2017 Jan-Feb;43(1):32-37. doi: 10.1590/S1806-37562016000000097.
- Individual participant dataSharing planned: No
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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.
Danish Hassan principal investigator
Riphah International 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, run by Riphah International University at 1 site in Pakistan.
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 3 inclusion and 3 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 6 Apr 2022. 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 Pakistan. 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?
International Physical Activity Questionnaire (IPAQ) (time frame: Day 1). The study lists 6 primary outcomes in all. 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 NCT05110755, 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 6 Apr 2022.