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Psychological DistressExer-WAPANCT07466979

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

A study testing Supervised Concurrent Exercise (Exer-WAPA) in people with Psychological Distress and Anxiety Symptoms, run by Universidad de Granada at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 35 to 60 years, women onlyHealthy volunteers can take part
What is being tested?
Supervised Concurrent Exercise (Exer-WAPA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSpain
Study dates
4 Mar 2025to 17 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 35 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Sport and Health University Research Institute (IMUDS), University of Granada

    Granada

Other trials in Spain

About this study

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.

Read more

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.

Read the detailed description

The Physical Exercise on Women's Affective and Physical HeAlth (Exer-WAPA) project is a randomised 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 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 will be assessed at baseline and post-intervention and will be grouped into five dimensions: (1) mental health, (2) physical health, (3) lifestyle, (4) gender-related outcomes, and (5) socioeconomic impact. Mental health and self-reported physical activity outcomes will be evaluated at three-month follow-up. Accordingly, the study follows a 2 × 3 statistical design.

  1. Mental Health In addition to emotional well-being as the primary psychological outcome, the following mental health variables will be assessed: risk of poor mental health, using the General Health Questionnaire (GHQ-12); self-esteem, using the Rosenberg Self-Esteem Scale (RSES); global life satisfaction, using the Satisfaction with Life Scale (SWLS); anxiety symptoms, using the Beck Anxiety Inventory (BAI); depressive symptoms, using the Beck Depression Inventory-II (BDI-II); and general cognitive status, using the Spanish version of the Montreal Cognitive Assessment (MoCA).
  2. Physical Health Health-related physical fitness will be assessed through health-related body composition (bioimpedance) and anthropometric indicators and physical fitness components, including cardiorespiratory fitness, using the 6-minute walk test; upper limb muscle strength, using handgrip dynamometry; lower limb muscle strength, using the 30 sit-to-stand test; upper limb flexibility, using the shoulder flexibility test; lower limb flexibility, using the chair sit-and-reach test; and agility, using the T-test. Cardiometabolic risk will be assessed using systolic and diastolic blood pressure measurements. Autonomic cardiovascular function will be assessed using heart rate variability (HRV). Static posture will also be assessed using the Fitness for Work Assessment Tool (OSPAT).
  3. Lifestyle Sociodemographic variables, including age, sex, educational level, marital status, employment status, and annual income, will be assessed. Prescribed and non-prescribed medication, and exposure to traumatic events will be assessed using a self-reported questionnaire. Physical activity, sedentary behaviour, and sleep quality will be assessed using Axivity triaxial accelerometers (AX3 and AX6). Self-reported physical activity and sedentary behaviour will be assessed using the Spanish version of the International Physical Activity Questionnaire (IPAQ), short version. Self-reported sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Commuting behaviour will be assessed using a self-administered questionnaire based on the ALPHA Environmental Questionnaire, including mode of commuting, reasons for the chosen mode of commuting, and whether the trip is made alone or accompanied to different destinations. Dietary habits will be assessed using the Mediterranean Diet Adherence Questionnaire (PREDIMED). Health-related quality of life will be assessed using the Spanish version of the SF-36 questionnaire. In addition, tobacco and alcohol consumption will be assessed using the AUDIT-C questionnaire.
  4. Gender-related outcomes Gender-related variables that may influence symptoms of anxiety and/or depression will be assessed. Sociodemographic variables, including gender, sexual orientation, relationship status, relationship satisfaction, parenthood, and caregiving responsibilities, will be assessed. Gender norms, including responsibilities at home, at work, and in caregiving, as well as social support and reproductive health, will be assessed using an adapted Spanish version of the Gender-Related Variables for Health Research (GVHR) questionnaire. Quality of life in menopausal women will be assessed using the Spanish version of the Menopause Quality of Life Questionnaire (MENQOL).
  5. Socioeconomic Impact The socioeconomic impact of the intervention will be evaluated through a cost-effectiveness analysis.

In addition, adherence and compliance variables related to the exercise intervention will be assessed. Attendance and punctuality at sessions will be assessed using session attendance records. Additional physical activity outside the training sessions will be assessed using self-reported questionnaire. Mood before and after each exercise session will be assessed using the Feeling Scale. Perceived exhaustion prior to the start of each session will be assessed using item 8 of the HPHEE Scale. Adverse events will be assessed using standardised incident reporting forms. Subjective session effort will be assessed using the Borg Rating of Perceived Exertion scale (RPE 0-10). Furthermore, immediately after completion of the intervention, participants in the experimental group will complete the Physical Activity Enjoyment Scale (PACES) to assess perceived enjoyment of physical activity during the program. In addition, a focus group will be conducted with a purposive subsample of participants from the experimental group to qualitatively explore their experiences, perceptions, and satisfaction with the intervention program.

Recruitment A total of 100 middle-aged women (35-60 years) with mild-to-moderate anxiety and/or depression symptoms will be recruited from Granada (Spain) and surrounding areas through local media, university communication channels, and social media platforms. Interested individuals will complete an online screening questionnaire, followed by a telephone screening to confirm eligibility based on inclusion and exclusion criteria.

Intervention Participants allocated 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 conducted three times per week, lasting 60 minutes each (180 minutes per week), in accordance with World Health Organization recommendations for physical activity in adults.

Exercise intensity will be individually prescribed and monitored using heart rate reserve (HRR), targeting intensities ranging from >50% to 85% HRR. Sessions will be conducted in groups and supervised by a graduate in Sports Science or a student enrolled in this degree program with experience in musically choreographed group fitness classes.

Session Structure and Monitoring Each training session will follow a standardized structure comprising a 5-minute warm-up, a main concurrent training phase combining resistance and endurance exercises, and a 10-minute mindfulness-based cool-down.

The main phase will be driven by musical cadence. All sessions will be accompanied by music delivered through an integrated sound system using wireless headphones with zero latency (Silent System), allowing for individual volume control. Musical tempo (beats per minute) will serve as the primary guide for exercise intensity and movement speed, structured as follows:

Resistance Component: Each music track will target one or two specific muscle groups. The BPM will dictate the repetition velocity, controlling the cadence of concentric and eccentric phases.

Aerobic Component: This phase will involve global movements and displacements performed as moderate-to-high intensity intervals (HIIT), where whole-body exercise speed is synchronized with the musical rhythm.

To ensure protocol adherence and safety, all sessions will be directly supervised by a certified trainer. The trainer's role is to monitor technical execution and ensure that participants strictly maintain the prescribed rhythm and movement velocity dictated by the music track, thereby validating the training intensity. A familiarization phase will be implemented at the beginning of the program to ensure correct exercise technique and execution. Exercise intensity will be progressively increased every three weeks by adjusting both the external load (kg) and the prescribed percentage of HRR.

Being tested
Supervised Concurrent Exercise (Exer-WAPA)
Keywords
Physical activity, Exercise, Women health, Psychological wellbeing, Mood disorders.
Medical subject headings
Anxiety Disorders, Depression, Motor Activity, Mood Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supervised Concurrent Exercise (Exer-WAPA)Behavioural

    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.

Study groups in NCT07466979
Study groupRoleWhat they receive
Exercise GroupExperimentalParticipants 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.
Receives: Behavioral: Supervised Concurrent Exercise (Exer-WAPA)
Waitlist Control GroupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2026
  2. Study start4 Mar 2025
  3. Primary completion11 Nov 2025
  4. Study completion17 Jul 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07466979
Sponsor's protocol ID
C-SEJ-304-UGR23
Acronym
Exer-WAPA
Status last verified
Mar 2026
First submitted
27 Feb 2026
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Supervised Concurrent Exercise (Exer-WAPA) in people with Psychological Distress and Anxiety Symptoms, run by Universidad de Granada at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emotional well-being (time frame: 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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