Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||40 Years - 75 Years|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Universidade Estadual de Londrina|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Carlos A Camillo, PT, PhD|
|Principal Investigator Affiliation||Universidade Estadual de Londrina|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Interstitial Lung Disease|
: Patients with ILD
Patients with a medical diagnosis of interstitial lung disease. Patients will be submitted to the assessment of: Daily physical activity levels; 6-minute walk test; Cardiopulmonary exercise testing; Muscle Function; Lung Function; Body composition; HRQoL - SGRQ-I; HRQoL - SF36; Anxiety and depression; Symptoms - mMRC Symptoms - UCSD/SOBQ; Sleep quality; Sleepiness; Inflammatory markers and oxidative stress.
: Control Group
Age-matched peers without lung diseases. Participants will be submitted to the assessment of: Daily physical activity levels; 6-minute walk test; Cardiopulmonary exercise testing; Muscle Function; Lung Function; Body composition; HRQoL - SF36; Anxiety and depression; Sleep quality; Sleepiness; Inflammatory markers and oxidative stress.
Diagnostic Test: - Daily physical activity levels
Objectively measured physical activity using activity monitors.
Diagnostic Test: - 6-minute walk test
Assessment of functional exercise capacity.
Diagnostic Test: - Cardiopulmonary exercise testing
Assessment of maximal exercise capacity.
Diagnostic Test: - Muscle Function
Assessment of muscle force, muscle endurance and muscle fatigability
Diagnostic Test: - Lung Function
Assessment of whole-body plethysmography and spirometry.
Diagnostic Test: - Body composition
Assessment of bioelectrical impedance.
Diagnostic Test: - HRQoL - SGRQ-I
Assessment of Health-related quality of life by the "Saint-George Respiratory questionnaire (SGRQ-I)"
Diagnostic Test: - Symptoms - UCSD/SOBQ
Assessment of symptoms by the "UCSD Short of breath questionnaire"
Diagnostic Test: - HRQoL - SF36
Assessment of Health-related quality of life by the "SF-36 questionnaire"
Diagnostic Test: - Anxiety and depression
Assessment of anxiety and depression by the "Hospital Anxiety And Depression (HADS) Scale"
Diagnostic Test: - Symptoms - mMRC
Assessment of symptoms by the "modified Medical Research Council (mMRC) scale"
Diagnostic Test: - Sleep quality
Assessment of sleep by the "Pitsburg Sleep Quality Index (PSQI)"
Diagnostic Test: - Sleepiness
Assessment of sleepiness by the "Epworth Sleepiness Scale"
Diagnostic Test: - Inflammatory markers and oxidative stress
blood assessment of inflammatory markers: IL-2, IL-10, IL-6, IL-4 e IL-17A, TNF, Interferon-γ, CK and CRP. Blood assessment of oxidative stress: TRAP, SH, SOD, CAT, PON 1, Gpx, MDA, NOx, FOX and AOPP.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.