NCT07417228

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

December 1, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

December 12, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2027

Last Updated

February 18, 2026

Status Verified

October 1, 2025

Enrollment Period

2 years

First QC Date

December 1, 2025

Last Update Submit

February 10, 2026

Conditions

Keywords

MenopausePerimenopauseConcurrent trainingExercise

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (14)

  • 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)

  • +9 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Concurrent training

Control

NO INTERVENTION

Interventions

Concurrent training programme

Intervention

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Currently participating in other structured exercise programmes.
  • Recent surgery or hospitalisation in the past 6 months.
  • Currently taking hormonal contraceptive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Dublin

Dublin, Dublin, Ireland

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Brian D Spring, BSc and MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

December 1, 2025

First Posted

February 18, 2026

Study Start

December 12, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 15, 2027

Last Updated

February 18, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Happy to share everything

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
01/01/2026 to 01/01/2029

Locations