An interventional study of Home-based Multicomponent Prehabilitation (Vivifrail) and Supervised Multicomponent Prehabilitation in Breast Cancer, Frailty and Sarcopenia, sponsored by Fundacion Miguel Servet. Recruiting at 1 site in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Fundacion Miguel Servet · Not applicable, Interventional, and Treatment
Older adults with breast cancer frequently present with frailty, decreased functional reserve, and increased risk of postoperative complications. Prehabilitation programs have emerged as a promising strategy to improve physical function and clinical outcomes; however, evidence in geriatric oncology remains limited, particularly regarding the role of biological markers in predicting response to such interventions.
This study aims to evaluate the effectiveness of a multicomponent prehabilitation program in older adults with breast cancer, focusing on functional status, clinical outcomes, and quality of life. In addition, the study seeks to characterize biological markers associated with frailty and treatment response, with the goal of identifying potential predictors of benefit from prehabilitation.
Participants will undergo a structured prehabilitation intervention including physical exercise, nutritional optimization, and comprehensive geriatric assessment. Clinical, functional, and biomarker data will be collected longitudinally.
The results of this study may contribute to improving personalized care strategies in geriatric oncology and to identifying patients who are most likely to benefit from prehabilitation programs.
This study is a prospective, randomized, controlled, single-blind clinical trial designed to evaluate the effectiveness of a multicomponent prehabilitation program in older adults with breast cancer, incorporating biological characterization to explore predictors of treatment response.
The trial will be conducted at the Navarre University Hospital (Pamplona, Spain). A total of 90 ambulatory patients aged 65 years or older with a confirmed diagnosis of breast cancer will be recruited and randomly assigned in a 1:1:1 ratio to usual care, a home-based multicomponent exercise program based on the Vivifrail methodology, or a supervised hospital-based intervention. All participants will undergo baseline frailty screening followed by a comprehensive geriatric assessment to characterize functional, cognitive, nutritional, and clinical status. Assessments will be repeated at predefined time points throughout the perioperative period and during follow-up.
The intervention is structured into preoperative and postoperative phases and includes individualized multicomponent exercise, nutritional optimization, and targeted management of geriatric syndromes. The hospital-based intervention consists of supervised sessions over six weeks (including a 2-week preoperative phase and a 4-week postoperative phase), while the home-based intervention is adapted to baseline functional status.
Clinical, functional, and biological data will be collected longitudinally to evaluate the impact of the intervention and to identify predictors of clinical outcomes and treatment response.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 90 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fundacion Miguel Servet is the lead sponsor of 48 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 29, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standard clinical care according to routine practice, including management by oncology and surgical teams. Identified geriatric conditions are communicated to the treating physician for appropriate management.
Participants perform a home-based multicomponent exercise program based on the Vivifrail methodology, including strength, endurance, balance, and flexibility training over six weeks, comprising a 2-week preoperative phase and a 4-week postoperative phase. The program is tailored according to baseline functional status and supported by caregiver supervision. Participants also receive comprehensive geriatric assessment and nutritional optimization.
Behavioral: Home-based Multicomponent Prehabilitation (Vivifrail) · Other: Comprehensive Geriatric Assessment and Optimization
Participants receive a supervised multicomponent exercise program delivered in the hospital setting, including aerobic, resistance, balance, and flexibility training over six weeks, including a 2-week preoperative phase and a 4-week postoperative phase. The intervention is combined with comprehensive geriatric assessment, nutritional optimization, and individualized management of geriatric syndromes.
Behavioral: Supervised Multicomponent Prehabilitation · Other: Comprehensive Geriatric Assessment and Optimization
Participants perform a structured home-based multicomponent exercise program based on the Vivifrail methodology, including strength, endurance, balance, and flexibility training over six weeks. The program is individualized according to baseline functional status.
Participants receive a structured, supervised multicomponent exercise program delivered in a hospital setting, including aerobic, strength, balance, and flexibility training over six weeks.
Participants undergo comprehensive geriatric assessment with targeted interventions including nutritional optimization, medication review, and management of geriatric syndromes.
Change in physical function assessed by Short Physical Performance Battery (SPPB)
Physical function will be assessed using the Short Physical Performance Battery (SPPB), a validated tool in older adults (score range 0-12, higher scores indicate better performance). The primary outcome will be the change in SPPB score from baseline to the end of the 6-week intervention period.
Time frame: Baseline to the end of the 6-week intervention period
Incidence of postoperative complications
Occurrence of postoperative complications within 30 days after surgery, classified according to the Clavien-Dindo classification.
Time frame: Within 30 days after surgery
Length of hospital stay
Number of days from surgery to hospital discharge.
Time frame: From date of surgery until hospital discharge, with a maximum follow-up of 30 days postoperatively
Functional decline after surgery
Functional decline defined as a decrease in the Short Physical Performance Battery (SPPB) score (range 0 to 12, with higher scores indicating better physical performance) or loss of independence in activities of daily living compared to baseline.
Time frame: Baseline to 30 days after surgery
Health-related quality of life
Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30; scores transformed to a 0-100 scale, where higher scores indicate better functioning or worse symptoms depending on the domain).
Time frame: Baseline to 30 days after surgery
Adherence to the intervention
Percentage of prescribed exercise sessions completed by participants.
Time frame: During the 6-week intervention period
Plan to share: No — Individual participant data will not be shared due to data protection regulations and institutional policies. De-identified data may be available from the corresponding author upon reasonable request, subject to ethical approval and data sharing agreements.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fundacion Miguel Servet