Status:
COMPLETED
EfiKroniK Research Program: Physical Exercise for People With Chronic Pathologies
Lead Sponsor:
Basque Health Service
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Neoplasms
Schizophrenia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Clinical objectives: estimate the common effect of the EfiKroniK physical exercise program for people with a set of Chronic diseases (solid cancers, hematological, schizophrenia and COPD), expressed i...
Detailed Description
Study design: This will be a multicentre pragmatic open-label type I hybrid implementation-effectiveness trial, in which a total of 370 patients each with one of 4 different chronic conditions, namel...
Eligibility Criteria
Inclusion
- colon, breast or lung solid cancers stage IV non-small cell, PS ≤1, with standard first-line chemotherapy treatment;
- malignant hemopathy with autologous transplant or lymphomas not localized, in treatment with immunotherapy
- Schizophrenia, including first episodes and other psychotic disorders
- COPD with BODE index 3-7 with clinical stability (absence of exacerbation, antibiotic treatment, systemic corticosteroids or hospitalization, in 30 days prior) and life expectancy\> 2 years.
- Adequate renal, hepatic and hematological function, with Hb\> 10, platelets\> 50,000, neutrophils\> 1,000. Karfnosky\> 60, ECOG ≥1.
Exclusion
- cerebral metastasis
- High risk of fracture due to bone metastasis
- Severe emotional instability
- Cardiorespiratory affectation or uncontrolled infection.
- Relapse or progression of the hematologic disease.
- Altered communication that prevents data collection or important cognitive impairment.
- Bronchiectasis and pulmonary alterations different from COPD.
- Other comorbidities that make it difficult or impossible to carry out the exercise program.
- Unmanaged TA (TAS\> 200 or TAD\> 110).
- Perform regular physical activity in a intensity, frequency and time equal or superior to the intervention of the supervised program.
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT03810755
Start Date
January 10 2018
End Date
December 31 2022
Last Update
February 8 2023
Active Locations (1)
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1
Primary care research unit of Bizkaia
Bilbao, Bizkaia, Spain, 48014