Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000974404
Ethics application status
Approved
Date submitted
11/08/2025
Date registered
4/09/2025
Date last updated
4/09/2025
Date data sharing statement initially provided
4/09/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Resistance Training on Body Composition in Females In or Approaching the Menopausal Transition
Scientific title
The Effect of Resistance Training on Body Composition in Females In or Approaching the Menopausal Transition
Secondary ID [1] 313348 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menopausal Transition 335706 0
Condition category
Condition code
Reproductive Health and Childbirth 332272 332272 0 0
Menstruation and menopause
Physical Medicine / Rehabilitation 334893 334893 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 329934 0
Treatment: Other
Comparator / control treatment
Phase 1 of the trial (WAITLIST CONTROL): The waitlist control group will be advised not to change habitual activity levels and will receive no specific instructions regarding physical activity. The waitlist control will last 12 weeks. Habitual physical activity will be tracked monthly. Upon completion of week 13 testing, the control group will begin the RT intervention.

Phase 2 of the trial (CONTROL): Participants randomised to the control group will not receive any advice or guidance.
Control group
Active

Outcomes
Primary outcome [1] 339846 0
Lean Body Mass (Phase 1 of trial)
Timepoint [1] 339846 0
Baseline, post-completion of the 12-week resistance training or control intervention, post-completion of the 12-week resistance training intervention for waitlist control group only
Primary outcome [2] 339847 0
Physical Activity levels (Phase 2 of trial)
Timepoint [2] 339847 0
Assessed prior to phase 2 commencement, monthly during 40 week intervention, and post-completion of the 40 week intervention
Primary outcome [3] 339848 0
Qualitative exploration of factors impacting physical activity levels over the duration of the trial. This outcome is specific to phase 3
Timepoint [3] 339848 0
One time point - within 2 weeks of completion of the 40 week intervention
Secondary outcome [1] 441636 0
Muscle strength (Phase 1)
Timepoint [1] 441636 0
Baseline, post-completion of the 12-week resistance training or control intervention, post-completion of the 12-week resistance training intervention for waitlist control group only
Secondary outcome [2] 441637 0
Work Performance (Phase 1)
Timepoint [2] 441637 0
Baseline, post-completion of the 12-week resistance training or control intervention, post-completion of the 12-week resistance training intervention for waitlist control group only
Secondary outcome [3] 441638 0
Exercise Self-Efficacy (Phase 1)
Timepoint [3] 441638 0
Baseline, post-completion of the 12-week resistance training or control intervention, post-completion of the 12-week resistance training intervention for waitlist control group only
Secondary outcome [4] 441639 0
High-density lipoprotein (HDL) (Phase 1)
Timepoint [4] 441639 0
Baseline, post-completion of the 12-week resistance training or control intervention, post-completion of the 12-week resistance training intervention for waitlist control group only
Secondary outcome [5] 451215 0
Blood pressure (Phase 1)
Timepoint [5] 451215 0
Baseline, post-completion of the 12-week resistance training or control intervention, post-completion of the 12-week resistance training intervention for waitlist control group only
Secondary outcome [6] 451216 0
Total cholesterol (Phase 1)
Timepoint [6] 451216 0
Baseline, post-completion of the 12-week resistance training or control intervention, post-completion of the 12-week resistance training intervention for waitlist control group only
Secondary outcome [7] 451218 0
Blood glucose (Phase 1)
Timepoint [7] 451218 0
Baseline, post-completion of the 12-week resistance training or control intervention, post-completion of the 12-week resistance training intervention for waitlist control group only
Secondary outcome [8] 451271 0
Bone mineral density (Phase 1 )
Timepoint [8] 451271 0
Baseline, post-completion of the 12-week resistance training or control intervention, post-completion of the 12-week resistance training intervention for waitlist control group only
Secondary outcome [9] 451272 0
Total fat mass (Phase 1)
Timepoint [9] 451272 0
Baseline, post-completion of the 12-week resistance training or control intervention, post-completion of the 12-week resistance training intervention for waitlist control group only
Secondary outcome [10] 451273 0
Visceral fat mass (Phase 1)
Timepoint [10] 451273 0
Baseline, post-completion of the 12-week resistance training or control intervention, post-completion of the 12-week resistance training intervention for waitlist control group only
Secondary outcome [11] 451274 0
Body fat percentage (Phase 1)
Timepoint [11] 451274 0
Baseline, post-completion of the 12-week resistance training or control intervention, post-completion of the 12-week resistance training intervention for waitlist control group only
Secondary outcome [12] 451275 0
Lean body mass (Phase 2)
Timepoint [12] 451275 0
Assessed prior to phase 2 commencement and post-completion of the 40 week intervention
Secondary outcome [13] 451276 0
Menopausal symptoms (Phase 1)
Timepoint [13] 451276 0
Baseline, post-completion of the 12-week resistance training or control intervention, post-completion of the 12-week resistance training intervention for waitlist control group only
Secondary outcome [14] 451277 0
Health related quality of life (Phase 1)
Timepoint [14] 451277 0
Baseline, post-completion of the 12-week resistance training or control intervention, post-completion of the 12-week resistance training intervention for waitlist control group only
Secondary outcome [15] 451564 0
Muscle strength (Phase 2)
Timepoint [15] 451564 0
Assessed prior to phase 2 commencement and post-completion of the 40 week intervention
Secondary outcome [16] 451565 0
Work Performance (Phase 2)
Timepoint [16] 451565 0
Assessed prior to phase 2 commencement and post-completion of the 40 week intervention
Secondary outcome [17] 451566 0
Exercise Self-Efficacy (Phase 2)
Timepoint [17] 451566 0
Assessed prior to phase 2 commencement and post-completion of the 40 week intervention
Secondary outcome [18] 451567 0
High-density lipoprotein (HDL) (Phase 2)
Timepoint [18] 451567 0
Assessed prior to phase 2 commencement and post-completion of the 40 week intervention
Secondary outcome [19] 451568 0
Blood pressure (Phase 2)
Timepoint [19] 451568 0
Assessed prior to phase 2 commencement and post-completion of the 40 week intervention
Secondary outcome [20] 451569 0
Total cholesterol (Phase 2)
Timepoint [20] 451569 0
Assessed prior to phase 2 commencement and post-completion of the 40 week intervention
Secondary outcome [21] 451570 0
Blood glucose (Phase 2)
Timepoint [21] 451570 0
Assessed prior to phase 2 commencement and post-completion of the 40 week intervention
Secondary outcome [22] 451571 0
Bone mineral density (Phase 2)
Timepoint [22] 451571 0
Assessed prior to phase 2 commencement and post-completion of the 40 week intervention
Secondary outcome [23] 451572 0
Total fat mass (Phase 2)
Timepoint [23] 451572 0
Assessed prior to phase 2 commencement and post-completion of the 40 week intervention
Secondary outcome [24] 451573 0
Visceral fat mass (Phase 2)
Timepoint [24] 451573 0
Assessed prior to phase 2 commencement and post-completion of the 40 week intervention
Secondary outcome [25] 451574 0
Body fat percentage (Phase 2)
Timepoint [25] 451574 0
Assessed prior to phase 2 commencement and post-completion of the 40 week intervention
Secondary outcome [26] 451575 0
Menopausal symptoms (Phase 2)
Timepoint [26] 451575 0
Assessed prior to phase 2 commencement and post-completion of the 40 week intervention
Secondary outcome [27] 451576 0
Health related quality of life (Phase 2)
Timepoint [27] 451576 0
Assessed prior to phase 2 commencement and post-completion of the 40 week intervention

Eligibility
Key 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).
Minimum age
38 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An investigator not involved in testing or delivery of the intervention will prepare the randomisation assignments. Group assignments will be delivered to participants in a sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
At both time points of randomisation, participants will be block randomised by groups of 10 using a computer generated list stratified by current use of hormone therapy, including but not limited to oral contraceptives, menopausal hormone therapy, transdermal estrogen, and intrauterine devices.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the resistance training and exercise maintenance trial, all data will be examined using linear mixed-effects models for repeated measures. For the resistance training intervention, the primary comparison will be the differences in changes from baseline between the intervention and control groups. For the behaviour maintenance intervention, the primary comparison will be the difference between groups from the new baseline established after the resistance training intervention to the end of the trial. Descriptive analysis for clinical notes will be used to describe intervention fidelity. Residuals will be checked for normality and transformations will be considered if assumptions are violated. Missing data will be managed using multiple imputation techniques and sensitivity analysis will use the imputed data.

For the semi-structured interview, an inductive analysis will be conducted [1], which allows for codes and sub-codes to describe themes as found in the data. Exploratory thematic analysis will be used as themes will be developed based solely on the perspectives of participants, rather than author’s perceptions. Transcripts from the interviews and clinical notes will be independently coded by two researchers to identify recurring themes and subthemes. NVivo12 (Lumivero; Denver, USA) will be used to record and collate quotes that exhibit ideas discussed regularly by participants. Critical discussion between the research team will allow theme coverage and structure to be evaluated and revised. Revisions may include alteration to descriptions of themes, re-allocation of meaning units, and deletion of some meaning units. Due to this being a small scale study, data will be categorised manually.

1. Braun, V. and V. Clarke, Using thematic analysis in psychology. Qualitative research in psychology, 2006. 3(2): p. 77-101.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
14/04/2025
Date of last participant enrolment
Anticipated
Actual
6/08/2025
Date of last data collection
Anticipated
7/08/2026
Actual
Sample size
Target
48
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317794 0
University
Name [1] 317794 0
University of New South Wales
Country [1] 317794 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 320142 0
None
Name [1] 320142 0
Address [1] 320142 0
Country [1] 320142 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316478 0
The University of New South Wales Committee C
Ethics committee address [1] 316478 0
Ethics committee country [1] 316478 0
Australia
Date submitted for ethics approval [1] 316478 0
18/11/2024
Approval date [1] 316478 0
31/03/2025
Ethics approval number [1] 316478 0
iREC7758

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138018 0
Dr Mandy Hagstrom
Address 138018 0
The University of New South Wales (UNSW) Sydney, High Street, Kensington, 2052, NSW, Australia
Country 138018 0
Australia
Phone 138018 0
+61 2 9065 3676
Fax 138018 0
Email 138018 0
[email protected]
Contact person for public queries
Name 138019 0
Anurag Pandit
Address 138019 0
The University of New South Wales (UNSW) Sydney, High Street, Kensington, 2052, NSW, Australia
Country 138019 0
Australia
Phone 138019 0
+61 2 9065 3676
Fax 138019 0
Email 138019 0
[email protected]
Contact person for scientific queries
Name 138020 0
Anurag Pandit
Address 138020 0
The University of New South Wales (UNSW) Sydney, High Street, Kensington, 2052, NSW, Australia
Country 138020 0
Australia
Phone 138020 0
+61 2 9065 3676
Fax 138020 0
Email 138020 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.