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Female Muscle Enhancement

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05397418
Acronym
FemME
Enrollment
72
Registered
2022-05-31
Start date
2022-05-01
Completion date
2023-11-23
Last updated
2024-06-11

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

Conditions

Muscle Function

Keywords

Muscle function, Females, Resistance exercise

Brief 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. 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.

Interventions

BEHAVIORALSupervised resistance exercise program

12 week supervised low impact resistance training program

BEHAVIORALUnsupervised resistance exercise program

12 week unsupervised low impact resistance training program

Sponsors

P.volve LLC
CollaboratorUNKNOWN
University of Exeter
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Two-arm parallel unblinded randomised design

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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. * 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

Design outcomes

Primary

MeasureTime frameDescription
Muscle function12 weeksPeak torque (Nm) of the shoulder and hip

Secondary

MeasureTime frameDescription
Body composition12 weeksChanges in fat mass and lean body mass
Bone mineral density12 weeksChanges in bone mineral density
Muscle thickness12 weeksChanges in muscle thickness
Muscle protein synthesis12 weeksRate of muscle protein synthesis
Energy expenditure12 weeksChanges in energy expenditure rates
Sleep Quality12 weeksChanges in sleep quality using the Pittsburgh sleep quality index (PSQI) questionnaire
Physical activity levels12 weeksChanges in physical activity energy expenditure as measured using an accelerometer
Exercise program acceptability12 weeksChanges 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
Changes in balance12 weeksBalance measured using the Y-balance test
Changes in flexibility12 weeksFlexibility measured using distance (cm) in zipper and sit and reach test
Changes in cardiovascular risk markers12 weeksChanges in biochemical lipid profile
Changes in diabetes risk markers12 weeksChanges in biochemical measures of HbA1c
Self reported quality of life12 weeksChanges in self reported wellbeing measures using the Short Form Survey (SF-36)

Other

MeasureTime frameDescription
Sustainability of the exercise program through monitoring class attendance when unsupervised.12 weeksSuitability of the exercise program as a sustainable form of unsupervised online exercise as recorded in participant exercise diaries.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026