BIZI ORAIN: Exercise for All People With Cancer

NCT ID: NCT03819595

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 311 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2024-02-06

Brief Summary

Background: Physical exercise should be an essential component of the therapeutic plan for every person diagnosed with cancer. However, most of these patients are inactive and only a few of them receive prescription and follow-up for safe and effective exercise plans.

Objective: in a first experimental phase, we will evaluate actual implementation (reach and adherence) and clinical effectiveness (physical fitness, quality of life and symptoms) of the BIZI ORAIN (BO) exercise program, for all patients diagnosed with cancer, compared to standardized physical activity counseling. In a second, observational phase, we will evaluate the association between levels of physical activity actually performed by all the participants and their 12 months evolution, in terms of physical fitness, quality of life, symptomatology and survival.

Design: Hybrid study, with a first experimental phase in which patients diagnosed with cancer will be randomly assigned to two parallel groups, one that immediately performs the BO program for 12 weeks and the other one that performs the same programme three months later (delayed treatment). In the second phase, observational, the entire cohort of participants will be followed-up for one year. Population: Any person diagnosed with cancer in the previous two years (minimum sample size = 1013) free of bone metastases, hematological or other exercise contraindications.

BIZI ORAIN program: based on the "Life Now" program of the Australian Cancer Council, BO is a 12-week small-group exercise program supervised by specially trained instructors combining moderate to high intensity aerobic and strength exercises (three 1 hour sessions a week).

Outcome measurements: the main outcome variable will be the change in functional capacity at three months (400 meters walk test). Secondary variables include mortality, quality of life (general SF-36 and cancer specific quality of life -European Organization for Research and Treatment of Cancer QLQ-C-30-), symptoms (Cancer-related fatigue - Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), exposure to physical activity level objectively registered with Actigraph wGT3X-BT accelerometer, chronic inflammation (C-reactive protein, adiponectin, and pro-inflammatory cytokines Il-1, Il-6 , and TNF-), body composition and bone health (dual-energy X-ray absorptiometry), measured at 0, 3, 6, and 12 months.

Analyses: changes observed in the outcome variables at three months will be compared between patients assigned to BO and to the reference group (delayed treatment) using analysis of the covariance, adjusted for baseline levels. To analyze the association between over time change in physical activity and the outcome variables mixed effects longitudinal models will be used for repeated measures throughout the 12 months of follow-up. Cox proportional hazards models will be used for the survival analysis. Qualitative analyses will combine a deductive approach with an inductive one based on Grounded Theory. In the deductive approach, the researchers will identify several thematic categories related to the Consolidated Framework for Implementation Research. Conclusions: BO is the first experience in Spain of a population-based exercise program that will guarantee, through a scientific evaluation, both clinical and implementation results. This will drastically advance the treatment of people suffering from cancer helping them to reverse the effects of their disease, the adverse effects of the therapies and to improve anti-cancer treatment efficacy, their quality of life and survival

Conditions

Cancer; Quality of Life; Functional Capacity; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Supervised arm

Supervised exercise. The intervention will be a free 12-week, small-group (\~10 people) exercise program supervised by specially trained instructors, combining two weekly 1h sessions of moderate to high intensity aerobic and strength exercise. Participants are encouraged to undertake an additional group-based walking exercise guided by target heart rates.

Group Type: EXPERIMENTAL

Supervised exercise

Intervention Type: OTHER

a free 12-week, small-group (\~10 people) exercise program supervised by specially trained instructors, combining two weekly 1h sessions of moderate to high intensity aerobic and strength exercise. Participants are encouraged to undertake an additional group-based walking exercise guided by target heart rates.

Control arm

Supervised exercise.The intervention will be a Personalized program (PVS), of proven effectiveness for the promotion of physical activity, diet and smoking cessation.

After 3 months, it become supervised arm

Group Type: ACTIVE_COMPARATOR

Supervised exercise

Intervention Type: OTHER

a free 12-week, small-group (\~10 people) exercise program supervised by specially trained instructors, combining two weekly 1h sessions of moderate to high intensity aerobic and strength exercise. Participants are encouraged to undertake an additional group-based walking exercise guided by target heart rates.

Personalized Program PVS

Intervention Type: OTHER

a standardized promotion prescription of physical activity, balanced diet and smoking cessation, using the computer tool "Promote Healthy Living" integrated into the electronic medical record.

Interventions

Supervised exercise

a free 12-week, small-group (\~10 people) exercise program supervised by specially trained instructors, combining two weekly 1h sessions of moderate to high intensity aerobic and strength exercise. Participants are encouraged to undertake an additional group-based walking exercise guided by target heart rates.

Intervention Type: OTHER

Personalized Program PVS

a standardized promotion prescription of physical activity, balanced diet and smoking cessation, using the computer tool "Promote Healthy Living" integrated into the electronic medical record.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• People diagnosed with cancer within the previous 2 years, under treatment or finished

Exclusion Criteria

• Neutropenia
• severe anemia
• bone metastases
• any musculoskeletal, cardiovascular or neurological disorder that could place the participant at risk of injury or illness resulting from the exercise program

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Basque Health Service

OTHER_GOV

Sponsor Role: lead

Responsible Party

Nere Mendizabal

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nere Mendizabal

Role: PRINCIPAL_INVESTIGATOR

Basque Health Service

Locations

Primary care research unit of Bizkaia

Bilbao, Bizkaia, Spain

Countries

Spain

References

Arietaleanizbeaskoa MS, Gil Rey E, Mendizabal Gallastegui N, Garcia-Alvarez A, De La Fuente I, Dominguez-Martinez S, Pablo S, Coca A, Gutierrez Santamaria B, Grandes G. Implementing Exercise in Standard Cancer Care (Bizi Orain Hybrid Exercise Program): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Aug 9;10(8):e24835. doi: 10.2196/24835.

Reference Type: DERIVED

PMID: 34383676 (View on PubMed)

Other Identifiers

PI 18/00929

Identifier Type: -

Identifier Source: org_study_id