Maximal Exercise Capacity and Extra-pulmonary Characteristics in Patients With Lung Cancer With Complete Remission .

NCT ID: NCT03838757

Last Updated: 2019-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-02-28

Brief Summary

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While lung cancer are rare disease in the early 20th century, its incidence increased in parallel with the increase in smoking habits. It is the most common type of cancer in the world. Despite advances in the efficacy of chemotherapy and radiotherapy regimens, surgical resection is the most effective curative treatment modality to improve survival in non-small cell lung cancer. Pulmonary resection candidates are selected according to not only tumor type and stage, but also functional status, exercise capacity, underlying lung disorders and health-related quality of life assessments. Patients with lung cancer often have lung and heart comorbidities that affect the outcome of the outcome measures and restricts cancer treatment options. In patients with lung cancer, shortness of breath, physical inactivity, weakness in peripheral muscles and exercise intolerance are described. Pulmonary rehabilitation is a multidisciplinary treatment designed to improve exercise capacity, functional status, health-related quality of life and to reduce the attenuation of chronic shortness of breath and fatigue in patients with chronic lung problems.

In literature, the effect of surgery in patients with lung cancer on postoperative respiratory muscle strength is not clear. There is no study investigating the effect of chemotherapy and radiotherapy on respiratory muscle strength. For these reasons, the aim of the study was to evaluate the curative period of non-small cell lung cancer patients with reliability and validity assessment methods. The hypothesis of our study was; when compared with patients with lung cancer and healthy individuals, exercise capacity, respiratory and peripheral muscle strength, physical activity levels, sleep and quality of life of lung cancer patients are reduced; dyspnoea, fatigue, depression, cough and pain levels increase.

Detailed Description

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According to sample size calculation 20 lung with complete remission cancer patients and 20 healthy individuals were included in the study. Cross-sectional observational research. The demographic, physical and physiological characteristics were recorded from the patient files. Exercise capacity (using cardiopulmonary exercise testing), physical activity, pulmonary functions, respiratory and peripheral muscle strength, dyspnea and fatigue perception, depression, cough, pain and quality of life were evaluated. Primary outcome measurement is maximal exercise capacity. Secondary outcomes are respiratory and peripheral muscle strength, pulmonary functions, physical activity, dyspnea and fatigue perception, depression, cough, pain and quality of life.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Patients

Maximal exercise capacity was assessed using cardiopulmonary exercise testing (CPET), exercise capacity six minute walk test, physical activity multi-sensor activity monitor, pulmonary function spirometry, respiratory muscle strength mouth pressure device, peripheral muscle strength hand held dynamometer, dyspnea Modified Medical Research Council Dyspnea Scale (MMRC), fatigue Fatigue Severity Scale, quality of life The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) and Functional Assessment of Cancer Therapy - Lung cancer quality of life questionnaire (FACT-L), depression Montgomery Asberg Depression scale, sleep of quality Pittsburgh Sleep Quality index and cough using Leicester Cough Questionnaire were evaluated.

No interventions assigned to this group

Healthy controls

Maximal exercise capacity was assessed using cardiopulmonary exercise testing (CPET), exercise capacity six minute walk test, physical activity multi-sensor activity monitor, pulmonary function spirometry, respiratory muscle strength mouth pressure device, peripheral muscle strength hand held dynamometer, dyspnea Modified Medical Research Council Dyspnea Scale (MMRC), fatigue Fatigue Severity Scale, quality of life The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) and Functional Assessment of Cancer Therapy - Lung cancer quality of life questionnaire (FACT-L), depression Montgomery Asberg Depression scale, sleep of quality Pittsburgh Sleep Quality index and cough using Leicester Cough Questionnaire were evaluated.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with; Diagnosed with lung cancer Stage 1, stage 2 and stage 3 patients in lung cancer patients Clinically stable and Under standard medication patients were included.

Exclusion Criteria

* Patients with Metastasis Orthopedic and neurological problems Acute infection Non-co-operable
* Healthy Subjects with Any diagnosed disease were excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Meral Boşnak Güçlü

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeynep Pelin Dündar, MSc

Role: STUDY_CHAIR

Gazi University

Meral Boşnak Güçlü, Assoc. Prof

Role: STUDY_DIRECTOR

Gazi University

Aydın Çiltaş, MD

Role: PRINCIPAL_INVESTIGATOR

Gebze Medical Park Hospital

Mustafa Benekli, MD

Role: PRINCIPAL_INVESTIGATOR

Cukurambar/Ankara

Locations

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Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

Yenimahalle, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Cavalheri V, Jenkins S, Cecins N, Gain K, Phillips M, Sanders LH, Hill K. Impairments after curative intent treatment for non-small cell lung cancer: a comparison with age and gender-matched healthy controls. Respir Med. 2015 Oct;109(10):1332-9. doi: 10.1016/j.rmed.2015.08.015. Epub 2015 Aug 29.

Reference Type RESULT
PMID: 26342839 (View on PubMed)

Granger CL, Denehy L, Parry SM, Martin J, Dimitriadis T, Sorohan M, Irving L. Which field walking test should be used to assess functional exercise capacity in lung cancer? An observational study. BMC Pulm Med. 2015 Aug 12;15:89. doi: 10.1186/s12890-015-0075-2.

Reference Type RESULT
PMID: 26264470 (View on PubMed)

Cavalheri V, Jenkins S, Cecins N, Gain K, Hill K. Comparison of the six-minute walk test with a cycle-based cardiopulmonary exercise test in people following curative intent treatment for non-small cell lung cancer. Chron Respir Dis. 2016 May;13(2):118-27. doi: 10.1177/1479972316631137. Epub 2016 Feb 11.

Reference Type RESULT
PMID: 26869579 (View on PubMed)

Granger CL, Parry SM, Edbrooke L, Denehy L. Deterioration in physical activity and function differs according to treatment type in non-small cell lung cancer - future directions for physiotherapy management. Physiotherapy. 2016 Sep;102(3):256-63. doi: 10.1016/j.physio.2015.10.007. Epub 2015 Oct 23.

Reference Type RESULT
PMID: 26597694 (View on PubMed)

Arbane G, Douiri A, Hart N, Hopkinson NS, Singh S, Speed C, Valladares B, Garrod R. Effect of postoperative physical training on activity after curative surgery for non-small cell lung cancer: a multicentre randomised controlled trial. Physiotherapy. 2014 Jun;100(2):100-7. doi: 10.1016/j.physio.2013.12.002. Epub 2014 Feb 12.

Reference Type RESULT
PMID: 24703523 (View on PubMed)

Hashmi A, Baciewicz FA Jr, Soubani AO, Gadgeel SM. Preoperative pulmonary rehabilitation for marginal-function lung cancer patients. Asian Cardiovasc Thorac Ann. 2017 Jan;25(1):47-51. doi: 10.1177/0218492316683757. Epub 2016 Dec 5.

Reference Type RESULT
PMID: 27913735 (View on PubMed)

Other Identifiers

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Gaziuniversity13

Identifier Type: -

Identifier Source: org_study_id

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