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The Effect of Resistance Training on Body Composition in Females In or Approaching the Menopausal Transition

The Effect of Resistance Training on Body Composition in Females In or Approaching the Menopausal Transition

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000974404
Enrollment
48
Registered
2025-09-04
Start date
2025-04-14
Completion date
2025-08-06
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary aim of this research study is to investigate the effect of resistance training on body composition in females in or approaching the menopausal transition. The aim of the second study is to investigate if an exercise care management model can maintain physical activity levels in this population. The entire study will be followed by a semi-structured interview to qualitatively assess differences in experiences across the study between participants who finish the trial as either insufficiently active, moderately active and active.

Interventions

This trial will have 3 phases. The same participants are utilised for all phases of the research project. Participants will first go through phase 1 (described below) where they are randomly assigned to a 12-week intervention group (RT) or a waitlist non-exercise control group (WC; allocation ratio RT:WC = 2:1). Following the WC period, the participants allocated to WC will receive the RT intervention. Following the RT intervention, all participants will commence phase 2 (described below) wher

This trial will have 3 phases. The same participants are utilised for all phases of the research project. Participants will first go through phase 1 (described below) where they are randomly assigned to a 12-week intervention group (RT) or a waitlist non-exercise control group (WC; allocation ratio RT:WC = 2:1). Following the WC period, the participants allocated to WC will receive the RT intervention. Following the RT intervention, all participants will commence phase 2 (described below) where participants are randomly assigned to a 40-week exercise care management model intervention group (EM), or a control group (CO; allocation ratio EM:CON = 1:1). Following phase 2, a sub sample of participants will be approached for a semi structured interview (described below under “Phase 3”). Phase 1 of the trial (RESISTANCE TRAINING): Participants randomised to resistance training (RT) will conduct a 12-week supervised RT program to be conducted two times per week (each session lasting approximately 60 minutes). Each session will be supervised by an accredited exercise physiologist and may consist of one or more participants. The exercise prescription will be split into three 4-week programs progressing in volume (sets per muscle group per week). The first block will largely consist of machine based exercises (e.g. machine chest press, wide grip cable row, 45 degree leg press) to introduce movements, and the subsequent blocks will progress to more free weight exercises (e.g., barbell bench press, bent over dumbbell row, rear foot elevated split squat). Attendance will be monitored and recorded as present/absent for each possible scheduled session. This will be recorded by the exercise physiologist at each session. Adherence will be tracked on an excel spreadsheet and will be recorded as adherence to exercise prescription (sets, reps, and load). Phase 2 of the trial (EXERCISE MAINTENANCE): Participants randomised into Exercise Maintenance will undertake 5 consultations (each consultation lasting approximately 45 minutes) with an exercise physiologist over a period of 40 weeks. The participants will be able to book in their exercise physiology visits as per their own individual preference (in-line with current access to Australian Medicare rebated allied health sessions). As per standard clinical practice, sessions will be individualised based on the needs of individual participants. Exercise physiology sessions typically include discussions around exercise behaviours, strategies to improve exercise behaviour and teaching techniques of new exercises. Attendance will be monitored and recorded as present/absent for each possible scheduled session. This will be recorded by the exercise physiologist at each session. Adherence will be tracked on an excel spreadsheet and will be recorded as adherence to the general exercise prescription provided at the previous session by the exercise physiologist. As prescription is varied and individualised as this is a behaviour maintenance phase, each session have adherence recorded separately (e.g. %attainment of step counts, minutes under taken of prescribed aerobic activity). If RT is prescribed, adherence will be monitored as in phase 1. Phase 3 (SEMI-STRUCTURED INTERVIEW): Following the study, participants may be approached for a semi-structured interview. We will aim to follow up an equal number of insufficiently active, moderately active and active participants based on average modified Godin leisure-time exercise questionnaire (GODIN) scores collected from the second half of the trail. Interviews will be conducted either in-person at the University of New South Wales or online via Microsoft Teams (Microsoft Corporation; Washington, USA). Questions will be semi-structured, open ended, and initiated by a researcher. General introductory questions will be asked to draw participants into discussion followed by questions pertaining to symptoms experienced. Topics explored will include physical activity participation prior to commencement of the study, barriers and enablers to physical activity, the impact of resistance training and 5 exercise physiology sessions on physical and psychological functioning, and the impact of the 5 exercise physiology sessions on influencing physical activity behaviours. Any new topics that may evolve will be discussed if they relate to physical activity. Participants will be encouraged to guide the conversation and provide personal examples relating to the topics brought up. Interviews will be digitally recorded and de-identified if a participant’s consent is obtained.

Sponsors

University of New South Wales
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
38 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Participants included will be apparently healthy individuals recorded female at birth, aged between 38 and 50, experiencing at least one menopausal symptom as classified by the menopausal rating scale (MRS), or reporting menstrual cycle irregularity, defined by persistent changes in cycle length of 7 days or greater as per the Stages of Reproductive Ageing Workshop (STRAW) +10, or female self-reports that they believe they are in the menopausal transition, or a medical professional has told the female that they are in the menopausal transition. Additionally, participants must not meet the Australian physical activity guidelines (i.e., engaging in < 150 minutes of moderate or < 75 minutes of vigorous physical activity per week and engaging in muscle strengthening activities 2 times per week).

Exclusion criteria

We are excluding females who are post-menopausal or experiencing amenorrhea for > 6 months (unless participant has an intrauterine device) due to the potential of becoming post-menopausal in the duration of the trial. Other exclusion criteria include females who have been regularly engaging resistance training over the previous 12 months; the presence of injury, disease or illness; adjuvant hormone therapy (e.g., Tamoxifen); pregnancy, previous bilateral oophorectomy, or presence of any known cardiovascular or musculoskeletal condition that precludes participation in exercise.

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 29, 2026