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 2026-04-15.
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 eight weeks, 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.
Exclusion Criteria:
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. 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 eight weeks. 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. 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 eight 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 8-week intervention.
Time frame: Baseline to 8 weeks (end of prehabilitation program)
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 8 weeks and 30 days post-surgery
Adherence to the intervention
Percentage of prescribed exercise sessions completed by participants.
Time frame: During the 8-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.
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