SarcopeniaWIANCT07860424
Women in Action: A Multicomponent Intervention for Older Women
A study testing Multicomponent exercise, nutrition, and psychoeducational program in people with Sarcopenia and Physical Inactivity, run by Universidad de Oviedo at 2 sites in Spain.
Trial summary
"Women in Action" is a quasi-experimental, mixed-methods study evaluating a 16-week multicomponent intervention (supervised strength/aerobic/balance training plus psychoeducational and nutrition-focused behavioral workshops) for women aged 55-75 in perimenopause, menopause, and early ageing. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Physical Inactivity, Menopause
- What is being tested?
- Multicomponent exercise, nutrition, and psychoeducational program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 2 sitesSpain
- Study dates
- Nov 2026to Jun 2028
- Phase
- Interventional
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 55 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites
University of Oviedo, Faculty of Teacher Education and Education, Oviedo, Asturias, Spain
Oviedo, Principality of Asturias, 33005
Noelia Belando, PhD., 620514995, belandonoelia@uniovi.es
Irene Barbero Alcocer
University of Oviedo, Faculty of Teacher Education and Education, Oviedo, Asturias, Spain
Oviedo, Principality of Asturias, 33005
About this study
Official title: "Women in Action": A Multicomponent Gender-Sensitive Intervention Combining Nutrition, Psychosocial Factors, and Strength Training in Perimenopausal, Menopausal, and Early-Aging Women-A Quasi-Experimental Study Protocol
"Women in Action" is a quasi-experimental, mixed-methods study evaluating a 16-week multicomponent intervention (supervised strength/aerobic/balance training plus psychoeducational and nutrition-focused behavioral workshops) for women aged 55-75 in perimenopause, menopause, and early ageing. The study will assess the feasibility, implementation fidelity, and acceptability of the program, together with its preliminary effects on a single primary outcome (handgrip strength) and secondary physical function, dietary, and psychosocial outcomes, compared with a passive control group receiving no intervention.
Read the detailed description
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.
- Conditions
- Sarcopenia, Physical Inactivity, Menopause, Healthy Aging
- Being tested
- Multicomponent exercise, nutrition, and psychoeducational program
- Keywords
- gender stereotypes, personal agency, strength training, Mediterranean diet, healthy ageing, physical function, older women, health behavior, community-based intervention
- Medical subject headings
- Sarcopenia, Sedentary Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent exercise, nutrition, and psychoeducational programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent | Experimental | Participants receive the 16-week "Women in Action" multicomponent program: supervised strength, aerobic, and balance training (2 sessions/week, 50-60 min/session) plus 8 biweekly psychoeducational and nutrition-focused behavioral workshops (90 min each; 4 nutrition-focused, 4 psychoeducational). Optional, separately consented co-educational workshops involving men are offered as an additional module. Receives: Behavioral: Multicomponent exercise, nutrition, and psychoeducational program |
| No multicomponent | No intervention | Participants maintain their usual lifestyle habits with no intervention exposure during the study period and receive basic intervention-related information after study completion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lower-Limb Strength
Standing-up and sitting-down test (number of repetitions of standing up and sitting down from a chair in 30 seconds).
Measured: 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).
Change in Handgrip Strength
Hand grip strength: Assessed using a manual (hand) dynamometer (kg).
Measured: 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).
Secondary outcomes (8)
Change in Body Composition (Fat, Muscle, and Bone Mass)
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)
Measured: 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).
Change in Basal Metabolic Rate
Basal metabolic rate in kcal.
Measured: 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).
Change in Body Mass Index (BMI)
BMI in kg/m²
Measured: 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).
Change in Mediterranean Diet Adherence Score
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).
Measured: 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).
Change in Personal Agency and Empowerment Score
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.
Measured: 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).
Change in Physical Self-Concept Score
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.
Measured: 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).
Change in Ageing- and Exercise-Related Stereotypes Score
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.
Measured: 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).
Change in Exercise Self-Efficacy Score
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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Oviedo
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Politécnico de Castelo Branco
- Responsible party
- Principal investigator, Noelia Belando Belando, Universidad de Oviedo
- Investigators
- Noelia Belando, PhD., Principal investigator, Universidad de Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860424
- Sponsor's protocol ID
- WIA-2026-01
- Acronym
- WIA
- Status last verified
- Oct 2026
- First submitted
- 27 Aug 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If individual-level data will not be shared beyond aggregate results, consistent with GDPR-compliant handling of participant data); confirm this choice with the University of Oviedo's data protection officer before submission.
Publications
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.
PubMed 34537803Gonzalez-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.
PubMed 38353251Yan 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.
PubMed 41212331Ramirez-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.
PubMed 28008239Streetman 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.
PubMed 41366451Deshayes 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.
PubMed 36506719Yu 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.
PubMed 41810309Qiu 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.
PubMed 40046765Guo 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.
PubMed 40370749Courel-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.
PubMed 34197791Chen 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.
PubMed 40800730Chalabaev 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.
PubMed 23070895Guralnik 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.
PubMed 10811152Sherrington 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.
PubMed 30703272Wallin 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.
PubMed 39162296