Female Muscle Enhancement (FemME)

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.

Study Overview

• Status: Completed
• Conditions: Muscle Function
• Intervention / Treatment: Behavioral: Supervised resistance exercise program; Behavioral: Unsupervised resistance exercise program

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Exeter, United Kingdom, EX1 2LT
    • University of Exeter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Supervised exercise program week 1-12, unsupervised exercise week 13-24.	Behavioral: Supervised resistance exercise program; 12 week supervised low impact resistance training program; Behavioral: Unsupervised resistance exercise program; 12 week unsupervised low impact resistance training program
Sham Comparator: Control group; Maintain habitual activity week 1-12, unsupervised exercise week 13-24.	Behavioral: Unsupervised resistance exercise program; 12 week unsupervised low impact resistance training program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle function	Peak torque (Nm) of the shoulder and hip	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Changes in fat mass and lean body mass	12 weeks
Bone mineral density	Changes in bone mineral density	12 weeks
Muscle thickness	Changes in muscle thickness	12 weeks
Muscle protein synthesis	Rate of muscle protein synthesis	12 weeks
Energy expenditure	Changes in energy expenditure rates	12 weeks
Sleep Quality	Changes in sleep quality using the Pittsburgh sleep quality index (PSQI) questionnaire	12 weeks
Self reported quality of life	Changes in self reported wellbeing measures using the Short Form Survey (SF-36)	12 weeks
Physical activity levels	Changes in physical activity energy expenditure as measured using an accelerometer	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	12 weeks
Changes in balance	Balance measured using the Y-balance test	12 weeks
Changes in flexibility	Flexibility measured using distance (cm) in zipper and sit and reach test	12 weeks
Changes in cardiovascular risk markers	Changes in biochemical lipid profile	12 weeks
Changes in diabetes risk markers	Changes in biochemical measures of HbA1c	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustainability of the exercise program through monitoring class attendance when unsupervised.	Suitability of the exercise program as a sustainable form of unsupervised online exercise as recorded in participant exercise diaries.	12 weeks

Collaborators and Investigators

• Sponsor: University of Exeter
• Collaborators: P.volve LLC
• Investigators: Principal Investigator: Francis Stephens, University of Exeter

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): November 23, 2023
• Study Completion (Actual): November 23, 2023

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Resistance exercise; Muscle function; Females
• Other Study ID Numbers: 2021-22-13; 309199 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No