BIZI ORAIN: Exercise for All People With Cancer

• ClinicalTrials.gov Identifier: NCT03819595
• Recruitment Status: Recruiting
• First Posted: January 28, 2019
• Last Update Posted: July 21, 2021
• Sponsor: Basque Health Service
• Information provided by (Responsible Party): Nere Mendizabal, Basque Health Service

Study Description

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

Condition or disease	Intervention/treatment	Phase
Cancer; Quality of Life; Functional Capacity; Exercise	Other: Supervised exercise; Other: Personalized Program PVS	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1013 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: "BIZI ORAIN": Exercise for All People With Cancer
• Actual Study Start Date: March 1, 2019
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: 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.
Active Comparator: 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	Other: 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.; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Functional Capacity (400 meters walk test) [ Time Frame: One year follow up. Measures at 0,3,6 and 12 months ]
   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.

Secondary Outcome Measures :

1. Change in Quality of life (general SF-36) [ Time Frame: 1 year follow up. Measures at 0,3,6 and 12 months ]
   The HRQL questionnaire is measured blindly with self-administered questionnaires: the Spanish version of the SF-36 and. Questionnaire will be filled out before and after the intervention. SF-36 generates an 8-dimension health profile and two summary scores for the physical and mental components. This questionnaire has been validated in the Spanish population. Measured at 0, 3, 6 and 12 months.
2. Change in Quality of life (cancer specific quality of life -European Organization for Research and Treatment of Cancer QLQ-C-30) [ Time Frame: 1 year follow up. Measures at 0,3,6 and 12 months ]
   Cancer specific quality of life is evaluated by the European Organisation for Research and Treatment of Cancer (QLQ-C-30) questionnaire (Aaronson et al., 1993). The QLQ-C-30 questionnaire includes five functional domains (physical, role, cognitive, emotional and social; higher scores represent greater function/quality of life) and three symptom scales (fatigue, pain and nausea; lower scores represent greater quality of life/less symptom severity).Measured at 0, 3, 6 and 12 months
3. symptoms (Cancer-related fatigue - Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [ Time Frame: 1 year follow up. Measures at 0,3,6 and 12 months ]
   a 13 items scale that measures the cancer related fatigue. The FACT-G scoring guide identifies those items that must be reversed before being added to obtain subscale totals. Negatively stated items are reversed by subtracting the response from "4". After reversing proper items, all subscale items are summed to a total, which is the subscale score.The higher score the score, the better the QOL. Measured at 0, 3, 6 and 12 months
4. physical activity level [ Time Frame: 1 year follow up. Measures at 0,3,6 and 12 months ]
   objectively registered with Actigraph wGT3X-BT accelerometer. Measured at 0, 3, 6 and 12 months
5. concentration of Lipids [ Time Frame: 3 months. Measures at 0,3 months. ]
   Lipids:cholesterol (mg/dl), tryglicerides (mg/dl), HDL (mg/dl), LDL(mg/dl). Measured at baseline, and 3 months
6. concentration of C reactive protein [ Time Frame: 3 months. Measures at 0,3 months. ]
   C reactive protein (mg/l). Measured at 0, and 3 months
7. concentration of glucose [ Time Frame: 3 months. Measures at 0,3 months. ]
   glycemia (mg/dl). Measured at 0, and 3 months
8. concentration of Insulin [ Time Frame: 3 months. Measures at 0,3 months. ]
   Insulin (microU/ml). Measured at 0, and 3 months
9. concentration of adiponectin [ Time Frame: 3 months. Measures at 0,3 months. ]
   Exercise specific parameters: adiponectin (microgr/mL). Measured at baseline, and 3 months
10. concentration of TNF [ Time Frame: 3 months. Measures at 0,3 months. ]
    Exercise specific parameters: TNF in Cancer patients (pg/ml) .Measured at baseline, and 3 months
11. concentration of Interleukins II-1 and II-6 [ Time Frame: 3 months. Measures at 0,3 months. ]
    Exercise specific parameters: Interleukins II-1 and II-6 (pg/ml). Measured at baseline, and 3 months
12. Change in Body composition (fat and muscular weight). (BMI) [ Time Frame: 1 year follow up. Measures at 0,3,6 and 12 months ]
    Body Mass Index (BMI): Diagnoses and classifies obesity. weight and height will be combined to report BMI in kg/m^2). Measured at baseline, and 3, 6, 12 months

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Nere Mendizabal; +34946006637; nere.mendizabalgallastegui@osakidetza.eus

Contact: Nere Mendizabal; +34946006637; neremendizabalgallastegui@osakidetza.eus

Locations

Spain

Primary care research unit of Bizkaia; Recruiting

Bilbao, Bizkaia, Spain, 48014

Contact: Nere Mendizabal Gallastegui 946006637 nere.mendizabalgallastegui@osakidetza.eus

Primary care research unit of Bizkaia; Not yet recruiting

Bilbao, Bizkaia, Spain, 48014

Contact: Nere Mendizabal Gallastegui 946006637 nere.mendizabalgallastegui@osakidetza.eus

Sponsors and Collaborators

Basque Health Service

Investigators

• Principal Investigator: Nere Mendizabal; Basque Health Service

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Arietaleanizbeaskoa MS, Gil Rey E, Mendizabal Gallastegui N, García-Álvarez A, De La Fuente I, Domínguez-Martinez S, Pablo S, Coca A, Gutiérrez Santamaría 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.

• Responsible Party: Nere Mendizabal, Principal Investigator, Basque Health Service
• ClinicalTrials.gov Identifier: NCT03819595
• Other Study ID Numbers: PI 18/00929
• First Posted: January 28, 2019
• Last Update Posted: July 21, 2021
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No