Exer-WAPA Project: Physical Exercise on Women's Affective and Physical HeAlth
NCT07466979 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-03-12
Summary
The Physical Exercise on Women's Affective and Physical HeAlth (Exer-WAPA) project is a randomized controlled trial (RCT) designed to evaluate the effects of a supervised, group-based exercise program incorporating music-synchronized movement on the emotional and physical health of physically inactive, middle-aged women (35-60 years) experiencing psychological distress.
The primary outcome will be emotional well-being, assessed at baseline and post-intervention using the Spanish version of the Positive and Negative Affect Schedule (PANAS). Secondary outcomes are grouped into five dimensions: (1) mental health, (2) physical health, (3) lifestyle, (4) gender-related outcomes, and (5) socioeconomic impact.
Mental health outcomes include risk of poor mental health (GHQ-12), self-esteem (Rosenberg Self-Esteem Scale), global life satisfaction (Satisfaction with Life Scale, SWLS), anxiety symptoms (Beck Anxiety Inventory, BAI), depressive symptoms (Beck Depression Inventory-II, BDI-II), and general cognitive status (Montreal Cognitive Assessment, MoCA).
Physical health outcomes include health-related body composition (bioimpedance) and anthropometric indicators, health-related physical fitness (cardiorespiratory fitness, muscular strength, flexibility, and agility), cardiometabolic risk (blood pressure), autonomic cardiovascular function (heart rate variability), static posture (OSPAT).
Lifestyle outcomes include physical activity and sedentary behaviour (Axivity accelerometers and IPAQ), sleep quality (Axivity accelerometers and Pittsburgh Sleep Quality Index, PSQI), commuting behaviour, dietary habits (Mediterranean Diet Adherence Questionnaire, PREDIMED), health-related quality of life (SF-36), and tobacco and alcohol consumption (AUDIT-C).
Gender-related outcomes include gender norms, caregiving responsibilities, reproductive health, social support (GVHR questionnaire), and menopause-related quality of life (MENQOL).
The socioeconomic impact of the intervention will be evaluated through a cost-effectiveness analysis.
A total of 100 participants will be recruited and randomly assigned to either an experimental group (GEx), receiving a 12-week supervised exercise intervention, or a waitlist control group (GC). The intervention follows World Health Organization (WHO) recommendations for physical activity (three sessions per week, 60 minutes per session; 180 minutes per week), with exercise intensity prescribed using heart rate reserve (50-85% HRR). Outcomes will be assessed at baseline, post-intervention, and three months after the intervention, following a 2 × 3 study design.
In addition, adherence and compliance outcomes related to the exercise intervention will also be assessed, including attendance and punctuality at sessions, additional physical activity outside the training sessions, mood before and after each exercise session (Feeling Scale), perceived exhaustion prior to the start of each session (item 8 of the HPHEE Scale), adverse events, and subjective session effort (Borg Rating of Perceived Exertion, RPE 0-10). Additionally, immediately after the completion of the intervention, experimental group participants will complete an exercise enjoyment questionnaire. Furthermore, a focus group will be conducted with a subsample of participants from the experimental group to explore their experiences with the intervention program.
Conditions
- Psychological Distress
- Anxiety Symptoms
- Depression Symptoms
Interventions
- BEHAVIORAL
-
Supervised Concurrent Exercise (Exer-WAPA)
The intervention consists of a supervised 12-week concurrent exercise programme combining aerobic and resistance training delivered through group-based fitness classes with musical and choreographed support. Sessions are held three times weekly (60 minutes per session) and follow a structured format including a warm-up, a combined aerobic-resistance training phase, and a mindfulness-based cool-down. Exercise intensity is individually prescribed and monitored using heart rate reserve (50-85% HRR) and progressively increased every three weeks by adjusting external load and target HRR. Musical tempo regulates movement cadence and exercise intensity. Sessions are delivered by qualified Sports Science professionals and include a familiarisation phase to ensure correct technique and safe execution.
Sponsors & Collaborators
-
Universidad de Granada
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Max Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-03-04
- Primary Completion
- 2025-11-11
- Completion
- 2026-07-17
Countries
- Spain
Study Locations
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