Female Muscle Enhancement

Muscle Function Clinical Trial

— FemME  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05397418
• Other study ID #: 2021-22-13
• Secondary ID: 309199
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: November 23, 2023

Study information

• Verified date: June 2024
• Source: University of Exeter
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 23, 2023
• Est. primary completion date: November 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Function

Intervention

Behavioral:
• Supervised resistance exercise program
12 week supervised low impact resistance training program
• Unsupervised resistance exercise program
12 week unsupervised low impact resistance training program

Locations

Country	Name	City	State
United Kingdom	University of Exeter	Exeter

Sponsors (2)

Lead Sponsor	Collaborator
University of Exeter	P.volve LLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

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