- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04722393
Lung Resection and Pulmonary Rehabilitation
Outcomes of Pulmonary Rehabilitation After Lung Resection in Patients With Non-Small Cell Lung Cancer
Lung cancer is the most common cancer in the world and surgical resection remains the gold standard curative treatment in early stage non-small cell lung cancer. However, surgery itself is the direct cause of pulmonary function impairment, which dramatically reduces patients tolerance to exercise and their quality of life. Pulmonary rehabilitation (PR) complements surgical treatment and improves patients' exercise and functional capacity, decreases dyspnea, improves health status.
Our aim is to examine the effectiveness of PR applied after lung resection in patients with lung cancer, 2- To determine whether the respiratory exercise training given to patients who could not participate in the PR program is effective.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Pulmonary rehabilitation (PR) is an evidence-based, interdisciplinary, comprehensive exercise program that targets patients with symptomatic chronic respiratory disease. PR integrates exercise and training interventions into a personalized treatment program. PR has become an important component of the general treatment strategy in patients with high-risk surgical diseases such as lung resection. It helps patients return to normal not only physically, but also emotionally and mentally. In patients with lung cancer, preoperative PR increases exercise capacity, decreases post-operative morbidity and mortality. Although it is reported that the PR program applied in the post-operative period increases physical performance and improves the quality of life, referral of patients in need of the PR unit is less than 25%. There is a need to increase the awareness of both pulmonologists and thoracic surgeons about the benefits of the PR program, which is a non-pharmacological and effective intervention.
The investigators have had two objectives in this study. 1- To examine the effectiveness of PR applied after lung resection in patients with lung cancer, 2- To determine whether the respiratory exercise training given to patients who could not participate in the PR program is effective.
An 8-week comprehensive outpatient PR program will applied to half of 66 patients with non-small cell lung cancer who underwent lung resection, and the other half received respiratory exercise training. After the intervention, the results of both groups will compare.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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İzmir, Truthahn, 35620
- İlknur Naz Gürşan
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Patients who had undergone surgery for non-small cell lung cancer in the last two years
- Patients who had no chemotherapy or radiotherapy
Exclusion Criteria:
- Patients who were found unsuitable with the cardiology consultation
- Patients with psychiatric problems
- Patients with severe joint diseases
- Reluctant patients
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Pulmonary Rehabilitation Group
An 8-week comprehensive outpatient PR program including respiratory exercises, aerobic and strengthening training
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Exercise training
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Sonstiges: Control Group
Respiratory exercises
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Exercise training
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Exercise Capacity
Zeitfenster: up to 8 weeks
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Six minutes walk test
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up to 8 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Respiratory Functions
Zeitfenster: up to 8 weeks
|
Pulmonary Function Test Pulmonary function test (PFT) which is noninvasive tests that show how well the lungs are working. The tests will measure FEV1; It is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration. FVC: It s the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry FEV1/FVC: It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC). |
up to 8 weeks
|
Dyspnea Sensation
Zeitfenster: up to 8 weeks
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Modified Medical Research Council (MMRC)" dyspnea scale, which consists of 5 items ranging between 1 and 5, to determine the severity of patients' shortness of breath.
Higher scores mean a worse outcome.
|
up to 8 weeks
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Disease Specific Quality of Life
Zeitfenster: up to 8 weeks
|
St. George's Respiratory Questionnaire (SGRQ) to determine disease-specific quality of life.
At this scale, high scores define worsened disease and increased symptoms.
Higher scores mean a worse outcome.
|
up to 8 weeks
|
Anxiety
Zeitfenster: up to 8 weeks
|
Hospital Anxiety and Depression (HAD) Inventory for assessment of anxiety and depression.
In this scale; scores of anxiety and depression are calculated separately.
The maximum score for both is 21 and high scores correspond to high degree anxiety and depression.
Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively.
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up to 8 weeks
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Depression
Zeitfenster: up to 8 weeks
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Hospital Anxiety and Depression (HAD) Inventory for assessment of anxiety and depression.
In this scale; scores of anxiety and depression are calculated separately.
The maximum score for both is 21 and high scores correspond to high degree anxiety and depression.
Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively.
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up to 8 weeks
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Body Mass Index
Zeitfenster: up to 8 weeks
|
Body mass index is calculated by dividing body mass by the square of length in meters
|
up to 8 weeks
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IKC123
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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