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临床试验/NCT07466979
NCT07466979进行中(未招募)不适用

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

Universidad de Granada1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月4日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Emotional well-being

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Supervised Concurrent Exercise (Exer-WAPA) (Behavioral)

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.

结局指标

主要结局

Emotional well-being

时间窗: 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).

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yaira Maria Barranco Ruiz

Associate Professor

Universidad de Granada

研究点 (1)

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