Muscle FunctionFemMENCT05397418
Female Muscle Enhancement
A study testing Supervised resistance exercise program and Unsupervised resistance exercise program in people with Muscle Function, run by University of Exeter at 1 site in United Kingdom.
Trial summary
Participating in regular physical activity has been shown to reduce the risk of developing some diseases and disabilities that can occur with ageing. Muscles naturally decline with age, and in females this appears to occur more so around the time of menopause. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Function
- What is being tested?
- Supervised resistance exercise program and Unsupervised resistance exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2022to 23 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females aged 40-60 years of age at time of screening.
- Body mass index <30kg/m2 and >18.5kg/m2
- Considered moderately active according to the 7 day International Physical Activity Questionnaire (IPAQ) (Craig et al., 2003)
- Self-reported as healthy (absence of injury or disease).
- Availability and willingness to attended 12 weeks of exercises classes 4-5 times per week at St Luke's Campus Exeter and participate in the study lasting a total of 26 weeks.
Who cannot join
- Pregnant, lactating or planning a pregnancy.
- Current diagnosis of a chronic disease such as diabetes, autoimmune disease, cardiovascular disease, kidney disease.
- Hysterectomy and/or ovariectomy.
- Currently prescribed hormone replacement therapy.
- Hypertension (BP ≥149/90 mm/Hg)
- Either current smoker, or history of smoking in the past 6 months.
Show all 12Show fewer
- Currently taking supplements that have been shown to impact muscle function and muscle mass, such as creatine, in the last 6 months.
- Prescribed medications that have been shown to impact muscle function and muscle mass, such as steroids, in the last 6 months.
- History of epilepsy.
- Current or recent injury within the last 6 months that may affect their ability to carry out the resistance training program.
- Advised not to exercise by their General Practitioner or medical professional.
- Resistance training consistently for 3 or more times per week for the last 2 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a 12-week Low Impact Resistance Training Programme on Muscle Function, Body Composition, Quality of Life and Muscle Protein Synthesis in Women Aged 40-60 Years
Participating in regular physical activity has been shown to reduce the risk of developing some diseases and disabilities that can occur with ageing. Muscles naturally decline with age, and in females this appears to occur more so around the time of menopause. Time, work, family commitments and the availability of facilities have all been identified as barriers to exercise in middle age.
Increasing activity levels in middle age appears to improve muscle function and bone health. However, there is a lack of evidence in how muscle function responds to low impact resistance exercise in middle aged females.
This study aims to assess the effectiveness and the mechanisms associated with building muscle as well as the effect on quality of life in middle aged (40-60 years) females using a low impact resistance training programme.
- Conditions
- Muscle Function
- Being tested
- Supervised resistance exercise program, Unsupervised resistance exercise program
- Keywords
- Muscle function, Females, Resistance exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised resistance exercise programBehavioural
12 week supervised low impact resistance training program
Unsupervised resistance exercise programBehavioural
12 week unsupervised low impact resistance training program
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Supervised exercise program week 1-12, unsupervised exercise week 13-24. Receives: Behavioral: Supervised resistance exercise program; Behavioral: Unsupervised resistance exercise program |
| Control group | Sham comparator | Maintain habitual activity week 1-12, unsupervised exercise week 13-24. Receives: Behavioral: Unsupervised resistance exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle function
Peak torque (Nm) of the shoulder and hip
Measured: 12 weeks
Secondary outcomes (13)
Body composition
Changes in fat mass and lean body mass
Measured: 12 weeks
Bone mineral density
Changes in bone mineral density
Measured: 12 weeks
Muscle thickness
Changes in muscle thickness
Measured: 12 weeks
Muscle protein synthesis
Rate of muscle protein synthesis
Measured: 12 weeks
Energy expenditure
Changes in energy expenditure rates
Measured: 12 weeks
Sleep Quality
Changes in sleep quality using the Pittsburgh sleep quality index (PSQI) questionnaire
Measured: 12 weeks
Self reported quality of life
Changes in self reported wellbeing measures using the Short Form Survey (SF-36)
Measured: 12 weeks
Physical activity levels
Changes in physical activity energy expenditure as measured using an accelerometer
Measured: 12 weeks
Exercise program acceptability
Changes in the rating of enjoyment of leisure time activity using the Groningen Enjoyment Questionnaire to rate enjoyment of exercise on a scale from strongly disagree to strongly agree
Measured: 12 weeks
Changes in balance
Balance measured using the Y-balance test
Measured: 12 weeks
Changes in flexibility
Flexibility measured using distance (cm) in zipper and sit and reach test
Measured: 12 weeks
Changes in cardiovascular risk markers
Changes in biochemical lipid profile
Measured: 12 weeks
Changes in diabetes risk markers
Changes in biochemical measures of HbA1c
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 May 2022
- Primary completion23 Nov 2023
- Study completion23 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel unblinded randomised design
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- P.volve LLC
- Responsible party
- Sponsor
- Investigators
- Francis Stephens, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397418
- Sponsor's protocol ID
- 2021-22-13
- Other IDs
- 309199
- Acronym
- FemME
- Status last verified
- Jun 2024
- First submitted
- 13 Jan 2022
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Svensen E, Koscien CP, Alamdari N, Wall BT, Stephens FB. A Novel Low-Impact Resistance Exercise Program Increases Strength and Balance in Females Irrespective of Menopause Status. Med Sci Sports Exerc. 2025 Mar 1;57(3):501-513. doi: 10.1249/MSS.0000000000003586. Epub 2024 Nov 6.
PubMed 39480197
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a 12-week Low Impact Resistance Training Programme on Muscle Function, Body Composition, Quality of Life and Muscle Protein Synthesis in Women Aged 40-60 Years
- ClinicalTrials.gov ID
- NCT05397418
- Acronym / sponsor ID
- FemME / 2021-22-13
- Conditions
- Muscle Function
- Keywords
- Muscle function, Females, Resistance exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- P.volve LLC
- Study start
- 1 May 2022 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participating in regular physical activity has been shown to reduce the risk of developing some diseases and disabilities that can occur with ageing. Muscles naturally decline with age, and in females this appears to occur more so around the time of menopause. Time, work, family commitments and the availability of facilities have all been identified as barriers to exercise in middle age.
Increasing activity levels in middle age appears to improve muscle function and bone health. However, there is a lack of evidence in how muscle function responds to low impact resistance exercise in middle aged females.
This study aims to assess the effectiveness and the mechanisms associated with building muscle as well as the effect on quality of life in middle aged (40-60 years) females using a low impact resistance training programme.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm parallel unblinded randomised design
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Supervised resistance exercise program, Behavioral: Unsupervised resistance exercise programSupervised exercise program week 1-12, unsupervised exercise week 13-24. |
| Control group | Sham comparator | Behavioral: Unsupervised resistance exercise programMaintain habitual activity week 1-12, unsupervised exercise week 13-24. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Females aged 40-60 years of age at time of screening.
- Body mass index <30kg/m2 and >18.5kg/m2
- Considered moderately active according to the 7 day International Physical Activity Questionnaire (IPAQ) (Craig et al., 2003)
- Self-reported as healthy (absence of injury or disease).
- Availability and willingness to attended 12 weeks of exercises classes 4-5 times per week at St Luke's Campus Exeter and participate in the study lasting a total of 26 weeks.
Key exclusion criteria (12 listed)
- Pregnant, lactating or planning a pregnancy.
- Current diagnosis of a chronic disease such as diabetes, autoimmune disease, cardiovascular disease, kidney disease.
- Hysterectomy and/or ovariectomy.
- Currently prescribed hormone replacement therapy.
- Hypertension (BP ≥149/90 mm/Hg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised resistance exercise program12 week supervised low impact resistance training program | Behavioural | Intervention group |
| Unsupervised resistance exercise program12 week unsupervised low impact resistance training program | Behavioural | Control group, Intervention group |
Primary outcome
Muscle function
Time frame: 12 weeks
Peak torque (Nm) of the shoulder and hip
13 secondary outcomes
Body composition
Time frame: 12 weeks
Bone mineral density
Time frame: 12 weeks
Muscle thickness
Time frame: 12 weeks
Muscle protein synthesis
Time frame: 12 weeks
Energy expenditure
Time frame: 12 weeks
Sleep Quality
Time frame: 12 weeks
Self reported quality of life
Time frame: 12 weeks
Physical activity levels
Time frame: 12 weeks
Exercise program acceptability
Time frame: 12 weeks
Changes in balance
Time frame: 12 weeks
Changes in flexibility
Time frame: 12 weeks
Changes in cardiovascular risk markers
Time frame: 12 weeks
Changes in diabetes risk markers
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Derived from this study: PubMed 39480197Svensen E, Koscien CP, Alamdari N, Wall BT, Stephens FB. A Novel Low-Impact Resistance Exercise Program Increases Strength and Balance in Females Irrespective of Menopause Status. Med Sci Sports Exerc. 2025 Mar 1;57(3):501-513. doi: 10.1249/MSS.0000000000003586. Epub 2024 Nov 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis Stephens principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised resistance exercise program and Unsupervised resistance exercise program in people with Muscle Function, run by University of Exeter at 1 site in United Kingdom.
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 12 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: finished, as of the sponsor's last update on 11 Jun 2024. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle function (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05397418, which also lists 1 linked publication.
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 11 Jun 2024.