NCT07466979: Exer-WAPA

Exer-WAPA Project: Physical Exercise on Women's Affective and Physical HeAlth

Active, enrolled NA Last updated 12 March 2026

What this trial tests

NA trial testing Supervised Concurrent Exercise (Exer-WAPA) in Psychological Distress in 100 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

4 March 2025

Primary endpoint
11 November 2025

17 July 2026

Quick facts

Lead sponsor	Universidad de Granada
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	4 March 2025
Primary completion	11 November 2025
Estimated completion	17 July 2026
Sites	1 location across Spain

Drugs / interventions tested

• Supervised Concurrent Exercise (Exer-WAPA)

Conditions studied

• Psychological Distress — all drugs for Psychological Distress →
• Anxiety Symptoms — all drugs for Anxiety Symptoms →
• Depression Symptoms — all drugs for Depression Symptoms →

Sponsor

Universidad de Granada — full company profile →

Who can join

Adults 35 to 60, female only, with Psychological Distress or Anxiety Symptoms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.