Female Muscle Enhancement (FemME)

University of Exeter

Status: Completed

Conditions: Muscle Function

Treatments: Behavioral: Supervised resistance exercise program; Behavioral: Unsupervised resistance exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT05397418

309199 (Other Identifier)

2021-22-13

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Intervention group

Experimental group

Description:

Supervised exercise program week 1-12, unsupervised exercise week 13-24.

Treatment:

Behavioral: Unsupervised resistance exercise program

Behavioral: Supervised resistance exercise program

Control group

Sham Comparator group

Description:

Maintain habitual activity week 1-12, unsupervised exercise week 13-24.

Treatment:

Behavioral: Unsupervised resistance exercise program