EfiKroniK Research Program: Physical Exercise for People With Chronic Pathologies

NCT03810755 | Completed

• 1 other identifier: PI17/01172
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Neoplasms; Schizophrenia; COPD; Physical Activity; Quality of Life; Primary Care

Outcome Measures

Primary Outcomes (1)

• Change in Functional capacity (6 minute walking test)

  The Test of the 6-minute applies to assess functional capacity, as well as a predictor of morbidity and mortality in people with different pathologies. Most of the daily activities that the patients with these pathologies are performed at submaximal exercise intensity, similar to this test is performed. In addition, as a method of controlling the intensity. Measurements: baseline, at the end of the exercise program, at 6 and 12 months

  One year follow up

Secondary Outcomes (20)

• Change in Health Related Quality of Life: EORTC QLQ- HDC30 in cancer

  One year follow up

• Change in Health Related Quality of Life: CAT and RQ in COPD

  One year follow up

• Change in Health Related Quality of Life ( SF36 for all pathologies)

  One year follow up

• Change in muscle strength (dynamometer)

  One year follow up

• Change in biological markers: Concentration of Lipids

  3 months

Study Arms (2)

Control group

OTHER

Personalized program (PVS), of proven effectiveness for the promotion of physical activity, diet and smoking cessation.

Other: Personalized Supervised physical activity

Supervision group

OTHER

Personalized Supervised physical activity: personalized exercise program for patients, supervised during 3 months by nursing in primary and autonomous care afterwards, with support from community resources

Other: Personalized Supervised physical activity

Interventions

Personalized Supervised physical activity OTHER

personalized exercise program for patients, supervised during 3 months by nursing in primary and autonomous care afterwards, with support from community resources

Control group; Supervision group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Basque Health Service: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Primary care research unit of Bizkaia

Bilbao, Bizkaia, 48014, Spain

Location

Related Publications (1)

• Arietaleanizbeaskoa MS, Sancho A, Olazabal I, Moreno C, Gil E, Garcia-Alvarez A, Mendizabal N, de la Fuente I, Dominguez S, Pablo S, Grandes G; EfiKroniK group. Effectiveness of physical exercise for people with chronic diseases: the EFIKRONIK study protocol for a hybrid, clinical and implementation randomized trial. BMC Fam Pract. 2020 Nov 6;21(1):227. doi: 10.1186/s12875-020-01298-4.

  PMID: 33158422 DERIVED

MeSH Terms

Conditions

Neoplasms; Schizophrenia; Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Active Comparator: Control group : PVS program, of proven effectiveness for the promotion of physical activity, diet and smoking cessation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Primary Care Research Unit of Bizkaia

Model Details: Experimental: Supervision group= personalized exercise program for patients, supervised during 3 months by nursing in primary and autonomous care afterwards, with support from community resources

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: January 22, 2019
• Study Start: January 10, 2018
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

ES (1)