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

NCT03838757 | Completed

• 1 other identifier: Gaziuniversity13
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

Lung cancer; Exercise capacity; Cardiopulmonary exercise test; Respiratory muscle strength; Physical activity; Pulmonary functions; Peripheral Muscle Strength; Quality of life; Sleep of quality; Dyspnea; Depression; Fatigue; Cough

Outcome Measures

Primary Outcomes (1)

• Maximal exercise capacity

  Cardiopulmonary exercise testing (Oxygen consumption measurement during test).

  Second day

Secondary Outcomes (12)

• Functional exercise capacity

  First day

• Physical activity

  First day

• Pulmonary function test

  First day

• Inspiratory and Expiratory muscle strength (MIP, MEP)

  First day

• Peripheral muscle strength

  First day

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

20 patients with lung cancer were included in the patients group and 20 healthy individuals were included in the control group

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Yenimahalle, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 26342839 RESULT

• 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.

  PMID: 26264470 RESULT

• 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.

  PMID: 26869579 RESULT

• 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.

  PMID: 26597694 RESULT

• 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.

  PMID: 24703523 RESULT

• 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.

  PMID: 27913735 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Motor Activity; Dyspnea; Depression; Fatigue; Cough

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms

Study Officials

• Zeynep Pelin Dündar, MSc

  Gazi University

  STUDY CHAIR

• Meral Boşnak Güçlü, Assoc. Prof

  Gazi University

  STUDY DIRECTOR

• Aydın Çiltaş, MD

  Gebze Medical Park Hospital

  PRINCIPAL INVESTIGATOR

• Mustafa Benekli, MD

  Cukurambar/Ankara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 12, 2019
• Study Start: December 31, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 12, 2019

Record last verified: 2019-02

Locations

TU (1)