CompletedNot Applicable

EfiKroniK Research Program: Physical Exercise for People With Chronic Pathologies

Spain370 participantsStarted 2018-01-10

Plain-language 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 in terms of functional capacity, quality of life and others results, regarding the standardized intervention of healthy habits 'Prescribe Healthy Living 'PVS. Implementation objectives: describe the adherence, continuity, adequacy and usefulness of EfiKroniK perceived by patients and professionals, with the purpose of designing implementation strategies, which will be evaluated in future trials. Design: clinical trial and implementation, pragmatic and randomized to two groups stratified by pathology, followed for 12 m. Participants: 370 patients diagnosed with solid cancers, hematological cancers, schizophrenia and COPD, in the most advanced stages. Scope: Hospital de Cruces, Basque Country University, Primary Care Research Unit of Bizkaia. Intervention: personalized exercise program for patients, supervised during 3 months by nursing in primary and autonomous care afterwards, with support from community resources. Reference group: PVS program, of proven effectiveness for the promotion of physical activity, diet and smoking cessation. Measurements: main measure of results: functional capacity at 3 months (6-minute test and submaximal running / running tests at foot to determine the speed of lactate thresholds) and quality of life at 6 and 12 months (SF-36 and specific questionnaires by pathology). Secondary variable results: physical and psychic symptomatology, biological markers, physical form and survival. Analysis: The common effect of the exercise will be estimated by comparing both groups by intention to treat, by means of analysis of the covariance of mixed effects for the changes observed at 3, 6 and 12 months adjusted for the baseline and possible confounders. Previously, a possible interaction effect between the pathology group and the effect of the intervention will be ruled out. The cost-effectiveness and cost-utility reasons.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

Change in Functional capacity (6 minute walking test)

Timeframe: One year follow up

Trial details

NCT IDNCT03810755

SponsorBasque Health Service

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2021-07-31