BIZI ORAIN: Exercise for All People With Cancer

NCT03819595 | Completed

• 1 other identifier: PI 18/00929
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Functional Capacity (400 meters walk test)

  The 400 meters walk Test 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. It would be measured at 0, 3,6 and 12 months.

  One year follow up. Measures at 0,3,6 and 12 months

Secondary Outcomes (12)

• Change in Quality of life (general SF-36)

  1 year follow up. Measures at 0,3,6 and 12 months

• Change in Quality of life (cancer specific quality of life -European Organization for Research and Treatment of Cancer QLQ-C-30)

  1 year follow up. Measures at 0,3,6 and 12 months

• symptoms (Cancer-related fatigue - Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

  1 year follow up. Measures at 0,3,6 and 12 months

• physical activity level

  1 year follow up. Measures at 0,3,6 and 12 months

• concentration of Lipids

  3 months. Measures at 0,3 months.

Study Arms (2)

Supervised arm

EXPERIMENTAL

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.

Other: Supervised exercise

Control arm

ACTIVE COMPARATOR

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

Other: Supervised exercise; Other: Personalized Program PVS

Interventions

Supervised exercise 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 arm

Personalized Program PVS 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.

Control arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Basque Health Service: lead

Study Sites (1)

Primary care research unit of Bizkaia

Bilbao, Bizkaia, 48014, Spain

Location

Related Publications (1)

• 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.

  PMID: 34383676 DERIVED

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Nere Mendizabal

  Basque Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 28, 2019
• Study Start: March 1, 2019
• Primary Completion: December 30, 2023
• Study Completion: February 6, 2024
• Last Updated: February 7, 2024

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)