University College Dublin
Dublin, Ireland
Location status: Recruiting
NCT Number: NCT07417228
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).
Interested in participating?
Request Info40 year–60 year
Female
Interventional
Not applicable
Dublin, Ireland
Location status: Recruiting
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
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.
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.
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
o Participants maintain usual activity during the study period.
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
Exclusion criteria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Concurrent training programme
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)
Measured in centimetres
Time frame: 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
Time frame: 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.
Time frame: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)
Measured in kilograms
Time frame: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)
Measured in centimetres
Time frame: 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).
Time frame: 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
Time frame: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)
Measured in kilograms
Time frame: 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
Contact information is provided by the study sponsor or research team.
University College Dublin
Other
Impact of Concurrent Training on Physical and Psychological Health in Women Experiencing Menopause
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