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

NCT07466979 | Active Not Recruiting

• 1 other identifier: C-SEJ-304-UGR23
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Physical activity; Exercise; Women health; Psychological wellbeing; Mood disorders.

Outcome Measures

Primary Outcomes (1)

• Emotional well-being

  The primary outcome will be emotional well-being, assessed using the Spanish version of the Positive and Negative Affect Schedule (PANAS). Positive Affect (PA) reflects the extent to which an individual feels enthusiastic, active, alert, joyful, and engaged in rewarding activities. Negative Affect (NA) represents a general dimension of subjective distress and unpleasant emotional engagement, encompassing a range of aversive emotional states such as disgust, anger, guilt, fear, and nervousness. The scale comprises 20 items, with 10 corresponding to the PA subscale and 10 to the NA subscale. Responses are provided on a 5-point Likert-type scale ranging from 1 to 5 (1 = hardly at all; 2 = a little; 3 = moderately; 4 = quite a lot; 5 = extremely). The Spanish version of the scale has demonstrated good psychometric properties in clinical populations with emotional disorders.

  Emotional well-being will be assessed at three time points: baseline (week 0), immediately after the 12-week intervention (week 12), and at 3-month follow-up (week 24).

Study Arms (2)

Exercise Group

EXPERIMENTAL

Participants assigned to the experimental group will undertake a supervised 12-week concurrent exercise intervention combining aerobic and resistance training, delivered through group-based fitness classes with musical and choreographed support. Sessions will be held three times weekly (60 minutes each; 180 minutes/week), in line with World Health Organization recommendations. The programme will be supervised by a graduate or student in Sports Science with experience in choreographed group fitness. Intensity will be individually prescribed using heart rate reserve (50-85% HRR). Each session will include a 5-minute warm-up, a combined aerobic-resistance phase, and a 10-min mindfulness-based cool-down. Sessions will be accompanied by music delivered through wireless headphones, with tempo controlling exercise intensity and pacing. A familiarisation phase will precede training to ensure proper technique. Intensity will progressively increase every three weeks by adjusting load and %HRR.

Behavioral: Supervised Concurrent Exercise (Exer-WAPA)

Waitlist Control Group

NO INTERVENTION

Participants assigned to the waitlist-control group will be invited to attend a series of educational sessions aimed at promoting healthy lifestyle and physical activity recommendations. These participants will not receive the exercise intervention during the study period and will be offered the exercise program after completion of the follow-up assessments.

Interventions

Supervised Concurrent Exercise (Exer-WAPA) BEHAVIORAL

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.

Exercise Group

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women from Granada and nearby areas aged 35 to 60 years
• Presence of mild psychological distress or dysthymia symptoms
• Physically inactive (not regularly engaging in physical-sport activities \<150 min/week of MVPA)
• No previous participation in physical conditioning or sports programs, or no participation within the past six months
• No disabling or high-risk health condition that contraindicates participation in a supervised exercise program
• Provide informed consent to participate
• Availability to attend the training program sessions at one of the scheduled times

You may not qualify if:

• Serious acute or terminal illness
• Severe psychiatric illness
• Diagnosed chronic cardiac, pulmonary, or metabolic disease
• Disabling osteo-muscular pathology (e.g., fracture, sprain) or neuromuscular disorder preventing physical activity
• Pregnancy
• Taking prescribed medication for dysthymia or sleep disorders, unless on treatment for more than one year with no symptom improvement
• Disagreement with the study conditions (e.g., group randomization, attendance at evaluations, etc.)
• Not signing the informed consent and/or the participation commitment form

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Sport and Health University Research Institute (IMUDS), University of Granada

Granada, Spain

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Motor Activity; Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 12, 2026
• Study Start: March 4, 2025
• Primary Completion: November 11, 2025
• Study Completion: July 17, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

ES (1)