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Starting soon Not applicable

Women in Action: A Multicomponent Intervention for Older Women

NCT07860424 · tracked via the Priya Life Science Spain tracker
Sponsor
Universidad de Oviedo
Phase
Not applicable
Started
2026-11
Last updated
2026-10-06

Condition(s) studied

SarcopeniaPhysical InactivityMenopauseHealthy Aging

Investigational drug(s) / intervention(s)

Multicomponent exercise, nutrition, and psychoeducational program

Multicomponent exercise, nutrition, and psychoeducational program: 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 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. 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.

Eligibility

Sex
FEMALE
Min age
55 Years
Max age
75 Years
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

  • 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).

Trial sites (2)

FacilityCityRegionStatus
University of Oviedo, Faculty of Teacher Education and Education, Oviedo, Asturias, Spain Oviedo Principality of Asturias
University of Oviedo, Faculty of Teacher Education and Education, Oviedo, Asturias, Spain Oviedo Principality of Asturias
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07860424 on ClinicalTrials.gov ↗ ← All trials in Spain