Clinical trial NCT05397418: Female Muscle Enhancement
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Function
Keywords: Muscle function
Females
Resistance exercise
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: P.volve LLC
First posted: 2022-05-31
Enrollment: 72
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel unblinded randomised design
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Muscle function
timeFrame: 12 weeks
Secondary outcomes:
measure: Body composition
timeFrame: 12 weeks
measure: Bone mineral density
timeFrame: 12 weeks
measure: Muscle thickness
timeFrame: 12 weeks
measure: Muscle protein synthesis
timeFrame: 12 weeks
measure: Energy expenditure
timeFrame: 12 weeks
measure: Sleep Quality
timeFrame: 12 weeks
measure: Self reported quality of life
timeFrame: 12 weeks
measure: Physical activity levels
timeFrame: 12 weeks
measure: Exercise program acceptability
timeFrame: 12 weeks
measure: Changes in balance
timeFrame: 12 weeks
measure: Changes in flexibility
timeFrame: 12 weeks
measure: Changes in cardiovascular risk markers
timeFrame: 12 weeks
measure: Changes in diabetes risk markers
timeFrame: 12 weeks
Other outcomes:
measure: Sustainability of the exercise program through monitoring class attendance when unsupervised.
timeFrame: 12 weeks
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
Study officials:
affiliation: University of Exeter
name: Francis Stephens
role: PRINCIPAL_INVESTIGATOR
References: