Assessment of Functional Capacity, Pain, Cognitive and Respiratory Functions in Lung Cancer Survivors

Serious side effects occurs with disease and treatments in survival after lung cancer. For this reason, functional capacity, cognitive status, pain perception and respiratory functions may be affected in lung cancer. The purpose of this study was to evaluate respiratory function, respiratory muscle strength and endurance, functional capacity, pain, cognitive status level, and physical activity in lung cancer patients and compare with the findings of healthy subjects

Study Overview

• Status: Completed
• Conditions: Survivorship; Lung Neoplasm
• Intervention / Treatment: Diagnostic test: Functional capacity

Detailed Description

This study was participated lung cancer patients survivors. Patients' pulmonary function test, functional capacity, respiratory muscle strength and endurance, pain and cognitive status was assessed and recorded.

Pulmonary function testing (PFT), mouth pressure measurement (MIP- maximal inspiratory pressure and MEP- maximal expiratory pressure), respiratory muscle endurance test, six minute walk test (6MWT) and pain threshold and tolerance test were used. In addition to physiological measurements, the Montreal Cognitive Assessment (MoCA) scale was used to evaluate cognitive status, the International Physical Activity Questionnaire (IPAQ) was used to determine the level of physical activity.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Lung cancer patients -> patients who were not under active cancer treatments Healthy -> No lung disease and systemic disease that affected outcome measure

Description

Inclusion Criteria:

• Cooperation
• lung cancer patients who had a stable condition

Exclusion Criteria:

• Active cancer treatments
• Brain metastasis story
• Any orthopedic disease impairs walking, balance

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung cancer patients; Lung cancer survivors who had stable conditions and routine follow-up at Hacettepe University Oncology Hospital	Diagnostic test: Functional capacity; Six minute walk test used assessment of functional capacity. For respiratory function mouth pressures, for cognitive functions MoCA scale and for pain assessment pain threshold and tolerance test assessed.; Other Names: Exercise capacity
Healthy subjects; No health problems related or affect outcome measure parameters examined in this study.	Diagnostic test: Functional capacity; Six minute walk test used assessment of functional capacity. For respiratory function mouth pressures, for cognitive functions MoCA scale and for pain assessment pain threshold and tolerance test assessed.; Other Names: Exercise capacity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity	Six minute walk test: Distance walked in six minute was recorded	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory muscle endurance	Pressure time unit: A constant load test was used to evaluate respiratory muscle endurance. Using a PowerBreathe device (HaB International Ltd., Southam, UK), the participants were asked to breathe maintaining a constant threshold (60% of MIP) until task failure, and the test duration was recorded. Results were obtained by multiplying the set pressure by the test duration	10 minutes
Respiratory muscle strength assessment	Respiratory muscle strength was evaluated by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).	10 minutes
Pulmonary functions test	pulmonary functions assessment via spirometry	15 minutes
Cognition using MoCA-Test	Cognitive function was evaluated with the secreening tool the Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point screening tool. Higher scores mean a better outcome.	10 minutes
Pressure pain threshold assessment	Pressure pain threshold was evaluated via algometer. The pressure at which the individual first reported pain was recorded.	15 minute
Pressure pain tolerance assessment	Pressure pain tolerance test was evaluated via algometer.The pressure at which the individual last pressure point at which they could endure the pain was recorded.	15 minute
Physical activity level	International Physical Activity Questionnaire-Short Form	5 minutes

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Chair: Saadettin Kilickap, Professor, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Cognitive dysfunction; Respiratory muscles
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: GO17/555

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No