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Menopause SymptomsNCT07417228

The Impact of Concurrent Training on Women Experiencing Symptoms of Menopause

A study testing Concurrent training in people with Menopause Symptoms, run by University College Dublin at 1 site in Ireland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 60 years, women only
Conditions the study is for
Menopause Symptoms
What is being tested?
Concurrent training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteIreland
Study dates
12 Dec 2025to 15 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • BMI >35 and <18.5.
  • Currently taking psychotropic medication
  • Has undergone a hysterectomy
  • Current substance abuse
  • Current diagnosis of a mental health disorder
  • Current diagnosis of a chronic illness
Show all 9Show fewer
  • Currently participating in other structured exercise programmes.
  • Recent surgery or hospitalisation in the past 6 months.
  • Currently taking hormonal contraceptive

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brian D Spring, BSc and MSc contact

0860795259 ext. +353

brian.spring@ucd.ie

Ireland1 site, 1 recruiting
  • University College Dublin

    Dublin, Dublin

    Brian D Spring, BSc MSc, 0860795259 ext. +353, brian.spring@ucd.ie

    Katy Horner, PhD, katy.horner@ucd.ie

    Recruiting

Other trials in Ireland

About this study

Official title: Impact of Concurrent Training on Physical and Psychological Health in Women Experiencing Menopause

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).

Read the 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).
  • 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
  1. Control Group
  • 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
  • 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
  • Transcripts and questionnaire responses will be anonymized and securely stored.
  • 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
  7. BMI >35 and <18.5.
  8. Currently taking psychotropic medication
  9. Has undergone bilateral oophorectomy
  10. Current substance abuse
  11. Current diagnosis of a mental health disorder
  12. Current diagnosis of a chronic illness
  13. Participates in a structured exercise program (e.g., gym workouts, fitness classes, sports training) more than once per week.
  14. Recent surgery or hospitalisation in the past 6 months.
  15. Currently taking hormonal contraceptive
Being tested
Concurrent training
Keywords
Menopause, Perimenopause, Concurrent training, Exercise
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Concurrent trainingBehavioural

    Concurrent training programme

Study groups in NCT07417228
Study groupRoleWhat they receive
InterventionExperimentalNot described
Receives: Behavioral: Concurrent training
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Menopause Symptoms (Menopause-Specific Quality of Life Questionnaire)

    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).

    Measured: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)

Secondary outcomes (14)
  1. Anxiety (GAD-7)

    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).

    Measured: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)

  2. Depression (Patient Health Questionnaire - 9)

    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).

    Measured: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)

  3. Pittsburgh Sleep Quality Index

    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)

    Measured: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)

  4. Body Appreciation Scale

    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).

    Measured: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)

  5. International Physical Activity Questionnaire

    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.

    Measured: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)

  6. Height

    Measured in centimetres

    Measured: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)

  7. Fat free mass

    Measured by bodpod in kilograms

    Measured: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)

  8. Blood Pressure

    Systolic and diastolic blood pressure will be recorded in mmHg.

    Measured: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)

  9. 3-RM Leg Press

    Measured in kilograms

    Measured: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)

  10. Counter Movement Jump height

    Measured in centimetres

    Measured: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)

  11. Astrand-Rhyming submaximal test

    Heart rate response to a standardised workload will be used to estimate maximal oxygen uptake (VO₂max).

    Measured: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)

  12. Grip-strength test

    Strength Test measured in kilograms

    Measured: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)

  13. Weight

    Measured in kilograms

    Measured: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)

  14. Fat Mass

    Measured using the Bodpod in kilograms

    Measured: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2026
  2. Study start12 Dec 2025
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion15 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07417228
Sponsor's protocol ID
18061996
Status last verified
Oct 2025
First submitted
1 Dec 2025
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Happy to share everything

Questions about this trial

What is this clinical trial studying?

A study testing Concurrent training in people with Menopause Symptoms, run by University College Dublin at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brian D Spring, BSc and MSc (0860795259 ext. +353, brian.spring@ucd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Menopause Symptoms (Menopause-Specific Quality of Life Questionnaire) (time frame: Baseline testing (within 2 weeks prior to intervention start date) and post testing (within 2 weeks post intervention end date)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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