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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.
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.
Age
35 - 60 years
Sex
FEMALE
Healthy Volunteers
Yes
Sport and Health University Research Institute (IMUDS), University of Granada
Granada, Spain
Start Date
March 4, 2025
Primary Completion Date
November 11, 2025
Completion Date
July 17, 2026
Last Updated
March 12, 2026
100
ESTIMATED participants
Supervised Concurrent Exercise (Exer-WAPA)
BEHAVIORAL
Lead Sponsor
Universidad de Granada
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07193329