Menopause Symptoms
Conditions
Keywords
Menopause, Perimenopause, Concurrent training, Exercise
Brief summary
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).
Detailed description
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 1. Baseline and Post-Intervention Assessments o Conduct assessments at two time points: baseline (pre-intervention) and after 12 weeks (post-intervention). Physical and Psychological Outcome Measures o Use a comprehensive testing battery including: Questionnaires (will be completed at home after in-person explanation): MENQOL (Menopause-Specific Quality of Life Questionnaire): Assesses the impact of menopausal symptoms on daily life and quality of life. GAD-7: Screens and measures severity of generalized anxiety. Patient Health Questionnaire-9 (PHQ-9):Measures the presence and severity of depressive symptoms. Pittsburgh Sleep Quality Index: Evaluates sleep quality and disturbances over the past month. Body Appreciation Scale: Assesses positive body image and body acceptance. International Physical Activity Questionnaire (IPAQ) : Allows researchers to estimate habitual physical activity levels Health tests (will be completed in UCD's Institute of Sport & Health) Anthropometric measurements: Measures heigh and weight for body size and composition estimates. BodPod scan: Measures body composition, including fat mass and fat-free mass using uses air displacement plethysmography. Blood pressure measurement: Assesses cardiovascular health using a sphygmomanometer. Functional tests: 3-RM Leg Press & 3-RM Cable Row: Measure maximal strength in lower and upper body, respectively. The leg press will be completed on a plate loaded leg press machine and the cable row will be completed on a cable machine. Counter Movement Jump: Assesses lower-body power. 1. Evaluates grip strength using an isokinetic dynamometer. Astrand-Rhyming submaximal test: A submaximal cycle ergometer test that estimates aerobic fitness through the use of a heart rate monitor. Physical Activity Monitoring Record habitual physical activity using: International Physical Activity Questionnaire (IPAQ) for self-reported activity. Dietary Monitoring 3-Day Food Diary. Two weekdays and one weekend day. 2\. Exercise Intervention Protocol The intervention group will undertake a supervised 12 week online concurrent training programme (three 45 minutes sessions a week). o Training includes: 5 minute warm up Body-weight aerobic exercises (15 minutes) Whole-body resistance exercises using resistance bands and body-weight (15 minutes) 5 minute cool down 3\. Control Group o Participants maintain usual activity during the study period. * After the study is complete the control group will be offered the exercise intervention Study 2 will qualitatively explore the subjective experiences of a subsample (n=25) of intervention participants following programme completion. Using semi-structured interviews guided by the Theoretical Domains Framework, this study will identify barriers and facilitators influencing exercise participation and adherence during menopause. Findings will inform the design of future exercise interventions to better support women managing menopausal symptoms. Methods of data collection Study 2: Qualitative Study Data Collection Methods o Semi-structured interviews: Conduct one-on-one interviews using a flexible interview guide based on the Theoretical Domains Framework (TDF) to explore experiences, barriers, and facilitators of engaging in exercise during menopause. These interviews will be done remotely via zoom. Interviews will be audio-recorded and transcribed verbatim. Data Management o Transcripts and questionnaire responses will be anonymized and securely stored. o Data will be coded and analysed thematically to identify key themes and insights related to exercise adherence and well-being. Inclusion criteria 1. Women experiencing perimenopause (irregular menstrual cycles of ≥7-day difference in cycle length of consecutive menstrual cycles) and early postmenopause (\< 5 years post menopause). 2. Able to safely engage in a concurrent training intervention that combines both aerobic and resistance training. 3. Must have reliable internet access and a device capable of participating in online training on zoom. 4. Willingness and ability to provide informed consent and comply with study procedures. 5. Aged between 40 and 60 years 6. Women who are either currently taking menopausal hormone therapy (MHT) or not taking MHT are eligible for inclusion. Exclusion criteria 1. BMI \>35 and \<18.5. 2. Currently taking psychotropic medication 3. Has undergone bilateral oophorectomy 4. Current substance abuse 5. Current diagnosis of a mental health disorder 6. Current diagnosis of a chronic illness 7. Participates in a structured exercise program (e.g., gym workouts, fitness classes, sports training) more than once per week. 8. Recent surgery or hospitalisation in the past 6 months. 9. Currently taking hormonal contraceptive
Interventions
BEHAVIORALConcurrent training
Concurrent training programme
Sponsors
University College Dublin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Women experiencing perimenopause (irregular menstrual cycles of ≥7-day difference in cycle length of consecutive menstrual cycles) and early postmenopause (\< 5 years post menopause). 2. Able to safely engage in a concurrent training interventions that combine both aerobic and resistance training. 3. Must have reliable internet access and a device capable of participating in online training on zoom. 4. Willingness and ability to provide informed consent and comply with study procedures. 5. Aged between 40 and 60 years
Exclusion criteria
1. BMI \>35 and \<18.5. 2. Currently taking psychotropic medication 3. Has undergone a hysterectomy 4. Current substance abuse 5. Current diagnosis of a mental health disorder 6. Current diagnosis of a chronic illness 7. Currently participating in other structured exercise programmes. 8. Recent surgery or hospitalisation in the past 6 months. 9. Currently taking hormonal contraceptive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Menopause Symptoms (Menopause-Specific Quality of Life Questionnaire) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety (GAD-7) | Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date) | 7 symptoms of anxiety listed. Participants are asked how often each symptom has bothered (on a scale of 0 to 3) them over the past 2 weeks (0=not at all; 1=several days; 2=more than half the days, 3=nearly everyday). |
| 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) | 9 symptoms of depression listed. Participants are asked how often each symptom has bothered (on a scale of 0 to 3) them over the past 2 weeks (0=not at all; 1=several days; 2=more than half the days, 3=nearly everyday). |
| Pittsburgh Sleep Quality Index | Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date) | 10 questions. For each question participants are asked to answer as relates to the past month. The first 4 questions are open ended and the next 5 are answered either (not during the past month; less than once a week; once or twice a week; three or more times a week) |
| Body Appreciation Scale | Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date) | 13 items. Participants are asked to give one of five possible answers for each of the 13-items (1-5). A higher score indicates a greater appreciation for one's body (1=never; 2=seldom; 3=sometimes, 4=often, 5=always). |
| International Physical Activity Questionnaire | Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date) | The IPAQ is a validated self-report questionnaire used to assess habitual physical activity over the previous 7 days. It captures the frequency and duration of walking, moderate-intensity, and vigorous-intensity physical activity, as well as sedentary time, allowing estimation of total physical activity expressed as MET-minutes per week. |
| Height | Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date) | Measured in centimetres |
| Fat free mass | Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date) | Measured by bodpod in kilograms |
| Blood Pressure | Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date) | Systolic and diastolic blood pressure will be recorded in mmHg. |
| 3-RM Leg Press | Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date) | Measured in kilograms |
| Counter Movement Jump height | Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date) | Measured in centimetres |
| Astrand-Rhyming submaximal test | Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date) | Heart rate response to a standardised workload will be used to estimate maximal oxygen uptake (VO₂max). |
| Grip-strength test | Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date) | Strength Test measured in kilograms |
| Weight | Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date) | Measured in kilograms |
| Fat Mass | Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date) | Measured using the Bodpod in kilograms |
Countries
Ireland
Contacts
CONTACTBrian D Spring, BSc and MSc
Outcome results
None listed