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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04431921
Other study ID # GO17/555
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 17, 2017
Est. completion date June 1, 2018

Study information

Verified date June 2020
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional capacity Six minute walk test: Distance walked in six minute was recorded 15 minutes
Secondary Respiratory muscle strength assessment Respiratory muscle strength was evaluated by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). 10 minutes
Secondary 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
Secondary Pulmonary functions test pulmonary functions assessment via spirometry 15 minutes
Secondary 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
Secondary Pressure pain threshold assessment Pressure pain threshold was evaluated via algometer. The pressure at which the individual first reported pain was recorded. 15 minute
Secondary 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
Secondary Physical activity level International Physical Activity Questionnaire-Short Form 5 minutes
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