BIZI ORAIN: Exercise for All People With Cancer

February 6, 2024 updated by: Nere Mendizabal, Basque Health Service

"BIZI ORAIN": Exercise for All People With Cancer

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

311

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bizkaia
      • Bilbao, Bizkaia, Spain, 48014
        • Primary care research unit of Bizkaia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
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

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year follow up. Measures at 0,3,6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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
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)
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
1 year follow up. Measures at 0,3,6 and 12 months
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
1 year follow up. Measures at 0,3,6 and 12 months
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
3 months. Measures at 0,3 months.
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
3 months. Measures at 0,3 months.
concentration of glucose
Time Frame: 3 months. Measures at 0,3 months.
glycemia (mg/dl). Measured at 0, and 3 months
3 months. Measures at 0,3 months.
concentration of Insulin
Time Frame: 3 months. Measures at 0,3 months.
Insulin (microU/ml). Measured at 0, and 3 months
3 months. Measures at 0,3 months.
concentration of adiponectin
Time Frame: 3 months. Measures at 0,3 months.
Exercise specific parameters: adiponectin (microgr/mL). Measured at baseline, and 3 months
3 months. Measures at 0,3 months.
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
3 months. Measures at 0,3 months.
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
3 months. Measures at 0,3 months.
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
1 year follow up. Measures at 0,3,6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nere Mendizabal, Basque Health Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

February 6, 2024

Study Registration Dates

First Submitted

January 18, 2019

First Submitted That Met QC Criteria

January 24, 2019

First Posted (Actual)

January 28, 2019

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • PI 18/00929

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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