Impact of Concurrent Training on Physical and Psychological Health in Women Experiencing Menopause
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Menopause Symptoms (Menopause-Specific Quality of Life Questionnaire)
研究概览
简要总结
The aim of this study is to examine the impact of a concurrent training exercise intervention on menopausal symptoms and key physical and mental health outcomes. The proposed study is powered based on a primary outcome of examining the change in menopausal symptoms using the MenQoL questionnaire. Participants (n=70) will be randomised to an intervention or control group. The intervention group will participate in a 12 week online (via zoom) concurrent training programme, consisting of three forty-five minute sessions (on non-consecutive days) per week that align with WHO exercise recommendations for adults and the control group will maintain their regular activity. The exercise classes will be delivered by qualified Sport & Exercise Scientists and will consist of a combination of bodyweight and resistance band exercises. Each class will consist of a 5 minute warm up, 15 minutes of aerobic exercise, 20 minutes of resistance training, and a 5 minute cool-down. Both groups will engage in pre and post testing through questionnaires (GAD-7, Patient Health Questionnaire-9 (PHQ-9), Menopause-Specific Quality of Life Questionnaire (MENQOL), Body Appreciation (BAS-2)), Pittsburgh Sleep Quality Index Sleep, International physical activity questionnaire (IPAQ), Body image questionnaire (BAS-2) and physical tests (Bod pod, grip-strength, 3-RM leg press, 3-RM cable pull, counter-movement jump and Astrand Rhyming submaximal aerobic test).
详细描述
Study 1 will examine the effects of a 12-week online concurrent training programme on menopausal symptoms and key physical and mental health outcomes. An independent researcher from UCD's Institute of Sport & Health will generate the randomisation sequence using Randomisation - The Definitive Platform for Research Randomization - Randomisation and the PI will then access the sequence to enroll each participant into their assigned group. The intervention group will complete three 45-minute Zoom sessions per week, combining aerobic and resistance training consistent with WHO exercise guidelines and the control group will maintain their regular activity levels. Each class will include a 5-minute warm-up, 15 minutes of aerobic exercise, 20 minutes of resistance training, and a 5-minute cool-down, led by qualified Sport and Exercise Scientists. The control group will maintain usual activity levels. Pre- and post-intervention assessments will include questionnaires (GAD-7, PHQ-9, MENQOL, BAS-2, Pittsburgh Sleep Quality Index, IPAQ) and physical tests (Bod Pod, grip strength, blood pressure, 3-RM leg press, 3-RM cable pull, countermovement jump, and Astrand Rhyming submaximal test). The primary outcome is change in menopausal symptoms measured by the MenQoL questionnaire.
The control group will not receive the intervention during their participation. However, after the study, they will be invited to attend a workshop on the benefits of exercise during menopause, including its effects on physical health, mood, and overall well-being. They will also be provided with a range of resources, such as exercise guides tailored for menopausal women.
Methods of data collection
N = 70 Perimenopausal and postmenopausal women who are experiencing symptoms of menopause.
Study 1 Concurrent training Intervention study
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
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women experiencing perimenopause (irregular menstrual cycles of ≥7-day difference in cycle length of consecutive menstrual cycles) and early postmenopause (< 5 years post menopause).
- •Able to safely engage in a concurrent training interventions that combine both aerobic and resistance training.
- •Must have reliable internet access and a device capable of participating in online training on zoom.
- •Willingness and ability to provide informed consent and comply with study procedures.
- •Aged between 40 and 60 years
排除标准
- •BMI >35 and <18.
- •Currently taking psychotropic medication
- •Has undergone a hysterectomy
- •Current substance abuse
- •Current diagnosis of a mental health disorder
- •Current diagnosis of a chronic illness
- •Currently participating in other structured exercise programmes.
- •Recent surgery or hospitalisation in the past 6 months.
- •Currently taking hormonal contraceptive
研究组 & 干预措施
Intervention
干预措施: Concurrent training (Behavioral)
Control
结局指标
主要结局
Menopause Symptoms (Menopause-Specific Quality of Life Questionnaire)
时间窗: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)
29 symptoms of menopause are listed. For each symptom participants are asked to indicate whether they have experienced the symptom in the past month. If they have experienced it they will be asked to rate (on a scale of 0-6) how much they have been bothered by that symptom (0=not bothered at all; 6=extremely bothered).
次要结局
- Height(Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date))
- Fat free mass(Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date))
- Fat Mass(Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date))
- Anxiety (GAD-7)(Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date))
- Depression (Patient Health Questionnaire - 9)(Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date))
- Pittsburgh Sleep Quality Index(Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date))
- Body Appreciation Scale(Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date))
- International Physical Activity Questionnaire(Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date))
- Blood Pressure(Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date))
- 3-RM Leg Press(Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date))
- Counter Movement Jump height(Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date))
- Astrand-Rhyming submaximal test(Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date))
- Grip-strength test(Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date))
- Weight(Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date))
研究者
Brian Spring
Mr
University College Dublin