Women in Action: A Multicomponent Intervention for Older Women

Participants will be allocated to an Intervention or Control group using a non-random, minimization-based procedure balancing key baseline characteristics (age, menopausal status, physical activity level, physical function, gender-related stereotype internalization, socioeconomic status, geographical context). The Intervention group receives supervised strength, aerobic, and balance training (2 sessions/week, 50-60 min, 16 weeks) plus 8 biweekly psychoeducational and nutrition-focused workshops (90 min each). Assessments occur at baseline (T0), mid-intervention (T1, week 8), post-intervention (T2, week 16), and 3-month follow-up (T3). The primary outcome is handgrip strength (T0 to T2 change). Secondary outcomes include the Short Physical Performance Battery, body composition (bioelectrical impedance analysis), Mediterranean diet adherence (MEDAS), a 3-day dietary record (energy and protein intake), and validated psychosocial instruments (personal agency/empowerment, physical self-concept, ageing- and exercise-related stereotypes, exercise self-efficacy). A qualitative strand (focus groups at T2 and T3) is integrated using a convergent parallel mixed-methods design. The primary analysis will use linear mixed-effects models under an intention-to-treat framework.

• Multicomponent exercise, nutrition, and psychoeducational program (Behavioral): 16-week program combining supervised resistance, aerobic, and balance training with psychoeducational and nutrition-focused behavioral workshops, delivered by qualified exercise professionals, psychologists, and nutrition professionals.

Primary outcomes

• Change in Lower-Limb Strength [1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).]: Standing-up and sitting-down test (number of repetitions of standing up and sitting down from a chair in 30 seconds).
• Change in Handgrip Strength [Time Frame: 1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).]: Hand grip strength: Assessed using a manual (hand) dynamometer (kg).

Secondary outcomes

• Change in Body Composition (Fat, Muscle, and Bone Mass) [1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).]: Assessed via bioelectrical impedance analysis (BIA), using a validated, standardized, field-applicable device. Measures: body mass (body fat, muscle mass, and bone mass in kg)
• Change in Basal Metabolic Rate [1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).]: Basal metabolic rate in kcal.
• Change in Body Mass Index (BMI) [1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).]: BMI in kg/m²
• Change in Mediterranean Diet Adherence Score [1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).]: Measured by the Mediterranean Diet Adherence Screener (MEDAS): score from 1 to 14. Scoring method: Some items are scored as "more than once a day" (equivalent to 1 point), and other items are scored as "three or more times a day/week" (equivalent to 1 point).
• Change in Personal Agency and Empowerment Score [1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).]: Measured by the Spanish Validated Scale of Personal Agency and Empowerment (ESAGE-Sp-19). Responses are collected using a Likert-type scale. A Likert scale consisting of 19 items organized into the following factors: Personal Agency, Self-Confidence, Internal Control, and Empowerment. There are 5 response options ranging from 0 (never) to 4 (always). The total score is the arithmetic mean.
• Change in Physical Self-Concept Score [1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).]: CAF-MAY score. 30-item Physical Self-Concept Questionnaire for Older Adults (CAF-MAY), which measures the subject's perception of the following dimensions of the personal self: physical ability (6 items), physical appearance (6 items), health/illness (6 items), functional ability (6 items), and general physical self-concept (6 items). The test is formatted as a Likert scale with 5 response options: strongly disagree (1) to strongly agree (5). The total score is the arithmetic mean.
• Change in Ageing- and Exercise-Related Stereotypes Score [1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).]: Measured by the Ageing Stereotypes and Exercise Scale (ASES). The ASES is a self-report measure assessing stereotypes about aging in the context of exercise and physical activity. The questionnaire consists of 15 items scored on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores are obtained by summing item responses and range from 15 to 75, with higher scores indicating more positive stereotypes regarding aging and exercise (more favorable beliefs about older adults' ability to engage in and benefit from exercise) and lower scores indicating more negative stereotypes and greater perceived barriers to exercise among older adults.
• Change in Exercise Self-Efficacy Score [1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).]: Self-Efficacy for Exercise Scale, SEE score. The Self-Efficacy for Exercise Scale is a self-report measure of an individual's confidence in their ability to engage in regular exercise under a variety of challenging conditions. The scale consists of 9 items, each rated on an 11-point scale ranging from 0 (Not Confident) to 10 (Very Confident). Total scores are calculated by summing all item responses and range from 0 to 90, with higher scores indicating greater self-efficacy for exercise (better outcome) and lower scores indicating lower confidence in the ability to maintain regular exercise (worse outcome).

Other outcomes

• Change in Number of Exercise Sessions Attended [1) intermediate assessment: week 8 and 2) post-intervention assessment: week 16; 3) follow-up evaluation (3 months after the intervention ended: Participants will be asked, via a Microsoft Forms questionnaire, how many weekly exercise session).]: Number of weekly exercise sessions attended by each participant out of the total sessions offered, self-reported via a Microsoft Forms questionnaire.

Sex: Female, ages: 55 Years to 75 Years, accepts healthy volunteers

Inclusion Criteria:

* Aged 55-75 years
* Residing in the Principality of Asturias, Spain
* Written informed consent
* Medical clearance for supervised moderate-to-vigorous physical activity
* Suboptimal physical activity level (not meeting WHO recommendations of ≥150 min/week moderate or ≥75 min/week vigorous aerobic activity and/or <2 muscle-strengthening sessions/week, and/or low adherence to prior exercise routines), screened via the Global Physical Activity Questionnaire (GPAQ)
* Relevant exposure to gender-related stereotypes associated with physical activity
* Willingness to complete all assessment phases (T0-T3)

Exclusion Criteria:

* Medical conditions contraindicating supervised exercise
* Severe cognitive impairment limiting program participation
* Concurrent involvement in structured resistance-training interventions
* Any physical or functional condition precluding safe execution of physical performance assessments (handgrip strength, SPPB)

• Marques DL, Neiva HP, Marinho DA, Marques MC. Velocity-Monitored Resistance Training in Older Adults: The Effects of Low-Velocity Loss Threshold on Strength and Functional Capacity. J Strength Cond Res. 2022 Nov 1;36(11):3200-3208. doi: 10.1519/JSC.0000000000004036. Epub 2021 Apr 5. PMID 34537803
• Gonzalez-Galvez N, Moreno-Torres JM, Vaquero-Cristobal R. Resistance training effects on healthy postmenopausal women: a systematic review with meta-analysis. Climacteric. 2024 Jun;27(3):296-304. doi: 10.1080/13697137.2024.2310521. Epub 2024 Feb 14. PMID 38353251
• Yan R, Chen Y, Zhang R, He J, Lin W, Sun J, Li D. Optimal resistance training prescriptions to improve muscle strength, physical function, and muscle mass in older adults diagnosed with sarcopenia: a systematic review and meta-analysis. Aging Clin Exp Res. 2025 Nov 10;37(1):320. doi: 10.1007/s40520-025-03235-w. PMID 41212331
• Ramirez-Campillo R, Diaz D, Martinez-Salazar C, Valdes-Badilla P, Delgado-Floody P, Mendez-Rebolledo G, Canas-Jamet R, Cristi-Montero C, Garcia-Hermoso A, Celis-Morales C, Moran J, Buford TW, Rodriguez-Manas L, Alonso-Martinez AM, Izquierdo M. Effects of different doses of high-speed resistance training on physical performance and quality of life in older women: a randomized controlled trial. Clin Interv Aging. 2016 Dec 13;11:1797-1804. doi: 10.2147/CIA.S121313. eCollection 2016. PMID 28008239
• Streetman AE, Walden RL, Orr CJ, Heerman WJ. Exercise empowerment: a scoping review of randomized controlled trials and quasi-experimental physical activity interventions. Int J Behav Nutr Phys Act. 2025 Dec 10;23(1):5. doi: 10.1186/s12966-025-01859-9. PMID 41366451
• Deshayes M, Palermo A, Korchi K, Philippe AG. Influence of negative stereotype on physical activity level among older adults during a training session. Front Sports Act Living. 2022 Nov 25;4:998724. doi: 10.3389/fspor.2022.998724. eCollection 2022. PMID 36506719
• Yu J, Li X, Yu H, Huang Y. Comparative effectiveness of exercise modalities and nutritional supplementation for sarcopenic obesity in older adults: a network meta-analysis based on randomized controlled trials. Front Public Health. 2026 Feb 23;14:1775783. doi: 10.3389/fpubh.2026.1775783. eCollection 2026. PMID 41810309
• Qiu H, Zheng W, Zhou X, Liu Q, Zhao X. Training modalities for elder sarcopenic obesity: a systematic review and network meta-analysis. Front Nutr. 2025 Feb 19;12:1537291. doi: 10.3389/fnut.2025.1537291. eCollection 2025. PMID 40046765
• Guo C, Dai T, Zhang H, Luo M, Gao J, Feng X. Effect of resistance training on body composition and physical function in older females with sarcopenic obesity-a systematic review and meta-analysis of randomized controlled trials. Front Aging Neurosci. 2025 Apr 30;17:1495218. doi: 10.3389/fnagi.2025.1495218. eCollection 2025. PMID 40370749
• Courel-Ibanez J, Buendia-Romero A, Pallares JG, Garcia-Conesa S, Martinez-Cava A, Izquierdo M. Impact of Tailored Multicomponent Exercise for Preventing Weakness and Falls on Nursing Home Residents' Functional Capacity. J Am Med Dir Assoc. 2022 Jan;23(1):98-104.e3. doi: 10.1016/j.jamda.2021.05.037. Epub 2021 Jun 29. PMID 34197791
• Chen J, Liu H, Zhao H, Yao J, Lu Y. The effects of vivifrail-based multicomponent training on physical and cognitive function in frail older adults: a systematic review and meta-analysis. Front Physiol. 2025 Jul 29;16:1646833. doi: 10.3389/fphys.2025.1646833. eCollection 2025. PMID 40800730
• Chalabaev A, Emile M, Corrion K, Stephan Y, Clement-Guillotin C, Pradier C, d'Arripe-Longueville F. Development and validation of the aging stereotypes and exercise scale. J Aging Phys Act. 2013 Jul;21(3):319-34. doi: 10.1123/japa.21.3.319. Epub 2012 Oct 11. PMID 23070895
• Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221. PMID 10811152
• Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb SE. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD012424. doi: 10.1002/14651858.CD012424.pub2. PMID 30703272
• Wallin A, Johansson S, Brincks J, Dalgas U, Franzen E, Callesen J. Effects of Balance Exercise Interventions on Balance-Related Performance in People With Multiple Sclerosis: A Systematic Review and a Meta-Analysis of Randomized Controlled Trials. Neurorehabil Neural Repair. 2024 Oct;38(10):775-790. doi: 10.1177/15459683241273402. Epub 2024 Aug 20. PMID 39162296
• Hwang CL, Yoo JK, Kim HK, Hwang MH, Handberg EM, Petersen JW, Christou DD. Novel all-extremity high-intensity interval training improves aerobic fitness, cardiac function and insulin resistance in healthy older adults. Exp Gerontol. 2016 Sep;82:112-9. doi: 10.1016/j.exger.2016.06.009. Epub 2016 Jun 21. PMID 27346646
• Singer A, Wolf M, Generoso L, Arias E, Delcastillo K, Echevarria E, Martinez A, Androulakis Korakakis P, Refalo MC, Swinton PA, Schoenfeld BJ. Give it a rest: a systematic review with Bayesian meta-analysis on the effect of inter-set rest interval duration on muscle hypertrophy. Front Sports Act Living. 2024 Aug 14;6:1429789. doi: 10.3389/fspor.2024.1429789. eCollection 2024. PMID 39205815
• Sanchez-Medina L, Gonzalez-Badillo JJ. Velocity loss as an indicator of neuromuscular fatigue during resistance training. Med Sci Sports Exerc. 2011 Sep;43(9):1725-34. doi: 10.1249/MSS.0b013e318213f880. PMID 21311352
• Ozemek C, Bonikowske A, Christle J, Gallo P, editors. ACSM's Guidelines for Exercise Testing and Prescription. 12th ed. Philadelphia: Wolters Kluwer; 2025.
• Fuller T, Peters J, Pearson M, Anderson R. Impact of the transparent reporting of evaluations with nonrandomized designs reporting guideline: ten years on. Am J Public Health. 2014 Nov;104(11):e110-7. doi: 10.2105/AJPH.2014.302195. Epub 2014 Sep 11. PMID 25211744
• Hu C, Xia Y, Zeng D, Ye M, Mei T. Effect of resistance circuit training on comprehensive health indicators in older adults: a systematic review and meta-analysis. Sci Rep. 2024 Apr 17;14(1):8823. doi: 10.1038/s41598-024-59386-9. PMID 38627495
• Robertson RJ, Goss FL, Rutkowski J, Lenz B, Dixon C, Timmer J, Frazee K, Dube J, Andreacci J. Concurrent validation of the OMNI perceived exertion scale for resistance exercise. Med Sci Sports Exerc. 2003 Feb;35(2):333-41. doi: 10.1249/01.MSS.0000048831.15016.2A. PMID 12569225
• Pareja-Blanco F, Loturco I. Level of Effort: A Practical Approach for Resistance Training Monitoring and Prescription. J Hum Kinet. 2026 Apr 30;102:259-266. doi: 10.5114/jhk/221229. eCollection 2026 Apr. PMID 42211812
• Currier BS, D'Souza AC, Singh MAF, Lowisz CV, Rawson ES, Schoenfeld BJ, Smith-Ryan AE, Steen JP, Thomas GA, Triplett NT, Washington TA, Werner TJ, Phillips SM. American College of Sports Medicine Position Stand. Resistance Training Prescription for Muscle Function, Hypertrophy, and Physical Performance in Healthy Adults: An Overview of Reviews. Med Sci Sports Exerc. 2026 Apr 1;58(4):851-872. doi: 10.1249/MSS.0000000000003897. Epub 2026 Mar 5. PMID 41843416
• Zhou Y, Wen K, Zhang X, Sun Y. Effects of resistance training on muscle mass, strength, and physical function in older women with sarcopenia: a systematic review and meta-analysis. Front Public Health. 2026 Jan 26;13:1735899. doi: 10.3389/fpubh.2025.1735899. eCollection 2025. PMID 41668861
• Valenzuela PL, Saco-Ledo G, Morales JS, Gallardo-Gomez D, Morales-Palomo F, Lopez-Ortiz S, Rivas-Baeza B, Castillo-Garcia A, Jimenez-Pavon D, Santos-Lozano A, Del Pozo Cruz B, Lucia A. Effects of physical exercise on physical function in older adults in residential care: a systematic review and network meta-analysis of randomised controlled trials. Lancet Healthy Longev. 2023 Jun;4(6):e247-e256. doi: 10.1016/S2666-7568(23)00057-0. Epub 2023 May 11. PMID 37182530
• Cabrolier-Molina J, Martin-Rodriguez A, Clemente-Suarez VJ. The Effects of Exercise Intervention in Older Adults With and Without Sarcopenia: A Systematic Review. Sports (Basel). 2025 May 19;13(5):152. doi: 10.3390/sports13050152. PMID 40423288
• Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014 Mar 7;348:g1687. doi: 10.1136/bmj.g1687. PMID 24609605
• Eglseer D, Traxler M, Schoufour JD, Weijs PJM, Voortman T, Boirie Y, Cruz-Jentoft AJ, Reiter L, Bauer S; SO-NUTS Consortium. Nutritional and exercise interventions in individuals with sarcopenic obesity around retirement age: a systematic review and meta-analysis. Nutr Rev. 2023 Aug 10;81(9):1077-1090. doi: 10.1093/nutrit/nuad007. PMID 36882046
• Heymans MW, Twisk JWR. Handling missing data in clinical research. J Clin Epidemiol. 2022 Nov;151:185-188. doi: 10.1016/j.jclinepi.2022.08.016. Epub 2022 Sep 21. PMID 36150546
• Casas-Herrero A, Saez de Asteasu ML, Anton-Rodrigo I, Sanchez-Sanchez JL, Montero-Odasso M, Marin-Epelde I, Ramon-Espinoza F, Zambom-Ferraresi F, Petidier-Torregrosa R, Elexpuru-Estomba J, Alvarez-Bustos A, Galbete A, Martinez-Velilla N, Izquierdo M. Effects of Vivifrail multicomponent intervention on functional capacity: a multicentre, randomized controlled trial. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):884-893. doi: 10.1002/jcsm.12925. Epub 2022 Feb 11. PMID 35150086
• Palombi T, Chirico A, Cazzolli B, Zacchilli M, Alessandri G, Filosa L, Borghi A, Fini C, Antoniucci C, Pistella J, Alivernini F, Baiocco R, Lucidi F. Motivation, psychological needs and physical activity in older adults: a qualitative review. Age Ageing. 2025 Jul 1;54(7):afaf180. doi: 10.1093/ageing/afaf180. PMID 40601367
• Navarro-Martinez R, Mafla-Espana MA, Cauli O. Mediterranean Diet Adherence in Community-Dwelling Older Adults in Spain: Social Determinants Related to the Family. Nutrients. 2022 Dec 2;14(23):5141. doi: 10.3390/nu14235141. PMID 36501170
• Sotos-Prieto M, Ortola R, Lopez-Garcia E, Rodriguez-Artalejo F, Garcia-Esquinas E. Adherence to the Mediterranean Diet and Physical Resilience in Older Adults: The Seniors-ENRICA Cohort. J Gerontol A Biol Sci Med Sci. 2021 Feb 25;76(3):505-512. doi: 10.1093/gerona/glaa277. PMID 33152061
• WHO Guidelines on Physical Activity and Sedentary Behaviour. Geneva: World Health Organization; 2020. Available from http://www.ncbi.nlm.nih.gov/books/NBK566045/ PMID 33369898
• Knowlton M, Newland BL. Beyond the Barbell: Women in Strength-Based Sports and the Reshaping of Gender Norms. Sex Roles. 2024;90(11):1567-1584. doi:10.1007/s11199-024-01521-x.
• Rua-Alonso M, Bovolini A, Costa-Brito AR, Vaz C, Marques E, Serra N, Lopes VP, Vila-Cha C. Exploring Perceived Barriers to Physical Activity among Older Adults Living in Low-Population Density Regions: Gender Differences and Associations with Activity Dimensions. Healthcare (Basel). 2023 Nov 11;11(22):2948. doi: 10.3390/healthcare11222948. PMID 37998440
• Schroder H, Fito M, Estruch R, Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Lamuela-Raventos R, Ros E, Salaverria I, Fiol M, Lapetra J, Vinyoles E, Gomez-Gracia E, Lahoz C, Serra-Majem L, Pinto X, Ruiz-Gutierrez V, Covas MI. A short screener is valid for assessing Mediterranean diet adherence among older Spanish men and women. J Nutr. 2011 Jun;141(6):1140-5. doi: 10.3945/jn.110.135566. Epub 2011 Apr 20. PMID 21508208
• Vasudevan A, Ford E. Motivational Factors and Barriers Towards Initiating and Maintaining Strength Training in Women: a Systematic Review and Meta-synthesis. Prev Sci. 2022 May;23(4):674-695. doi: 10.1007/s11121-021-01328-2. Epub 2021 Nov 20. PMID 34800250
• Fragala MS, Cadore EL, Dorgo S, Izquierdo M, Kraemer WJ, Peterson MD, Ryan ED. Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning Association. J Strength Cond Res. 2019 Aug;33(8):2019-2052. doi: 10.1519/JSC.0000000000003230. PMID 31343601
• Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169. PMID 30312372
• Meredith SJ, Cox NJ, Ibrahim K, Higson J, McNiff J, Mitchell S, Rutherford M, Wijayendran A, Shenkin SD, Kilgour AHM, Lim SER. Factors that influence older adults' participation in physical activity: a systematic review of qualitative studies. Age Ageing. 2023 Aug 1;52(8):afad145. doi: 10.1093/ageing/afad145. PMID 37595070
• Moreno-Llamas A, Garcia-Mayor J, De la Cruz-Sanchez E. Gender inequality is associated with gender differences and women participation in physical activity. J Public Health (Oxf). 2022 Dec 1;44(4):e519-e526. doi: 10.1093/pubmed/fdab354. PMID 34604911

• Study Protocol: Study Protocol "Women in Action" description (PDF, 2026-07-07)
• Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study Protocol: Woman in Action (PDF, 2026-09-11)
• Study Protocol: Study Protoco (PDF, 2026-09-05)
• Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study Protocol and Anexo (PDF, 2026-10-01)
• Study Protocol and Statistical Analysis Plan: Study Protoco_Women in action_REVISED (PDF, 2026-09-17)
• Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study Protocol_Statistical Analysis Plan and Ethics Committe (PDF, 2026-09-25)
• Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study protocol with Ethics committee (PDF, 2026-09-17)
• Informed Consent Form: PATIENT INFORMATION SHEET (PDF, 2026-10-01)

• Noelia Belando, PhD., Principal investigator, Universidad de Oviedo