NCT04722393

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

2.2 years

First QC Date

January 13, 2021

Last Update Submit

January 20, 2021

Conditions

Keywords

pulmonary rehabilitationlung surgerylung cancer

Outcome Measures

Primary Outcomes (1)

  • Exercise Capacity

    Six minutes walk test

    up to 8 weeks

Secondary Outcomes (6)

  • Respiratory Functions

    up to 8 weeks

  • Dyspnea Sensation

    up to 8 weeks

  • Disease Specific Quality of Life

    up to 8 weeks

  • Anxiety

    up to 8 weeks

  • Depression

    up to 8 weeks

  • +1 more secondary outcomes

Study Arms (2)

Pulmonary Rehabilitation Group

EXPERIMENTAL

An 8-week comprehensive outpatient PR program including respiratory exercises, aerobic and strengthening training

Other: Exercise

Control Group

OTHER

Respiratory exercises

Other: Exercise

Interventions

Exercise training

Control GroupPulmonary Rehabilitation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who had undergone surgery for non-small cell lung cancer in the last two years
  • Patients who had no chemotherapy or radiotherapy

You may not qualify if:

  • Patients who were found unsuitable with the cardiology consultation
  • Patients with psychiatric problems
  • Patients with severe joint diseases
  • Reluctant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İlknur Naz Gürşan

Izmir, 35620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pulmonary Rehabilitation Group and Control Group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 25, 2021

Study Start

October 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 25, 2021

Record last verified: 2021-01

Locations