CancerNCT03819595
BIZI ORAIN: Exercise for All People With Cancer
A study testing Supervised exercise and Personalized Program PVS in people with Cancer and Quality of Life, run by Basque Health Service at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Quality of Life, Functional Capacity
- What is being tested?
- Supervised exercise and Personalized Program PVS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2019to 6 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- People diagnosed with cancer within the previous 2 years, under treatment or finished
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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.
Read more
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
- Being tested
- Supervised exercise, Personalized Program PVS
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exerciseOther
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 PVSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Supervised exercise; Other: Personalized Program PVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year follow up. Measures at 0,3,6 and 12 months
Secondary outcomes (12)
Change in Quality of life (general SF-36)
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.
Measured: 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)
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
Measured: 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)
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
Measured: 1 year follow up. Measures at 0,3,6 and 12 months
physical activity level
objectively registered with Actigraph wGT3X-BT accelerometer. Measured at 0, 3, 6 and 12 months
Measured: 1 year follow up. Measures at 0,3,6 and 12 months
concentration of Lipids
Lipids:cholesterol (mg/dl), tryglicerides (mg/dl), HDL (mg/dl), LDL(mg/dl). Measured at baseline, and 3 months
Measured: 3 months. Measures at 0,3 months.
concentration of C reactive protein
C reactive protein (mg/l). Measured at 0, and 3 months
Measured: 3 months. Measures at 0,3 months.
concentration of glucose
glycemia (mg/dl). Measured at 0, and 3 months
Measured: 3 months. Measures at 0,3 months.
concentration of Insulin
Insulin (microU/ml). Measured at 0, and 3 months
Measured: 3 months. Measures at 0,3 months.
concentration of adiponectin
Exercise specific parameters: adiponectin (microgr/mL). Measured at baseline, and 3 months
Measured: 3 months. Measures at 0,3 months.
concentration of TNF
Exercise specific parameters: TNF in Cancer patients (pg/ml) .Measured at baseline, and 3 months
Measured: 3 months. Measures at 0,3 months.
concentration of Interleukins II-1 and II-6
Exercise specific parameters: Interleukins II-1 and II-6 (pg/ml). Measured at baseline, and 3 months
Measured: 3 months. Measures at 0,3 months.
Change in Body composition (fat and muscular weight). (BMI)
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
Measured: 1 year follow up. Measures at 0,3,6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start1 Mar 2019
- Primary completion30 Dec 2023
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nere Mendizabal, Basque Health Service
- Investigators
- Nere Mendizabal, Principal investigator, Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819595
- Sponsor's protocol ID
- PI 18/00929
- Status last verified
- Jul 2022
- First submitted
- 18 Jan 2019
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34383676
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "BIZI ORAIN": Exercise for All People With Cancer
- ClinicalTrials.gov ID
- NCT03819595
- Acronym / sponsor ID
- PI 18/00929
- Conditions
- Cancer, Quality of Life, Functional Capacity, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised arm | Experimental | Other: Supervised exerciseSupervised 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. |
| Control arm | Active comparator | Other: Supervised exercise, Other: Personalized Program PVSSupervised 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- People diagnosed with cancer within the previous 2 years, under treatment or finished
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised exercisea 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 | Control arm, Supervised arm |
| Personalized Program PVSa standardized promotion prescription of physical activity, balanced diet and smoking cessation, using the computer tool "Promote Healthy Living" integrated into the electronic medical record. | Other | Control arm |
Primary outcome
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.
12 secondary outcomes
Change in Quality of life (general SF-36)
Time frame: 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
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
physical activity level
Time frame: 1 year follow up. Measures at 0,3,6 and 12 months
concentration of Lipids
Time frame: 3 months. Measures at 0,3 months.
concentration of C reactive protein
Time frame: 3 months. Measures at 0,3 months.
concentration of glucose
Time frame: 3 months. Measures at 0,3 months.
concentration of Insulin
Time frame: 3 months. Measures at 0,3 months.
concentration of adiponectin
Time frame: 3 months. Measures at 0,3 months.
concentration of TNF
Time frame: 3 months. Measures at 0,3 months.
concentration of Interleukins II-1 and II-6
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Derived from this study: PubMed 34383676Arietaleanizbeaskoa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nere Mendizabal principal investigator
Basque Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise and Personalized Program PVS in people with Cancer and Quality of Life, run by Basque Health Service at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Capacity (400 meters walk test) (time frame: One year follow up. Measures at 0,3,6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03819595, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.