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OpenTrials
Completed

NCT Number: NCT05397418

Female Muscle Enhancement

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.

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Key information

Conditions

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Exeter

Exeter, EX1 2LT, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supervised resistance exercise program

Behavioral

12 week supervised low impact resistance training program

Unsupervised resistance exercise program

Behavioral

12 week unsupervised low impact resistance training program

Primary outcomes

  1. Muscle function

    Time frame: 12 weeks

    Peak torque (Nm) of the shoulder and hip

Secondary outcomes

  1. Body composition

    Time frame: 12 weeks

    Changes in fat mass and lean body mass

  2. Bone mineral density

    Time frame: 12 weeks

    Changes in bone mineral density

  3. Muscle thickness

    Time frame: 12 weeks

    Changes in muscle thickness

  4. Muscle protein synthesis

    Time frame: 12 weeks

    Rate of muscle protein synthesis

  5. Energy expenditure

    Time frame: 12 weeks

    Changes in energy expenditure rates

  6. Sleep Quality

    Time frame: 12 weeks

    Changes in sleep quality using the Pittsburgh sleep quality index (PSQI) questionnaire

  7. Self reported quality of life

    Time frame: 12 weeks

    Changes in self reported wellbeing measures using the Short Form Survey (SF-36)

  8. Physical activity levels

    Time frame: 12 weeks

    Changes in physical activity energy expenditure as measured using an accelerometer

  9. Exercise program acceptability

    Time frame: 12 weeks

    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

  10. Changes in balance

    Time frame: 12 weeks

    Balance measured using the Y-balance test

  11. Changes in flexibility

    Time frame: 12 weeks

    Flexibility measured using distance (cm) in zipper and sit and reach test

  12. Changes in cardiovascular risk markers

    Time frame: 12 weeks

    Changes in biochemical lipid profile

  13. Changes in diabetes risk markers

    Time frame: 12 weeks

    Changes in biochemical measures of HbA1c

Other outcomes

  1. Sustainability of the exercise program through monitoring class attendance when unsupervised.

    Time frame: 12 weeks

    Suitability of the exercise program as a sustainable form of unsupervised online exercise as recorded in participant exercise diaries.

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • P.volve LLC

Registry information

Official study 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

Acronym: FemME

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 31, 2022
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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