FemME: Female Muscle Enhancement

Sponsor
University of Exeter (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05397418
Collaborator
P.volve LLC (Other)
62
1
2
21.1
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Supervised resistance exercise program
  • Behavioral: Unsupervised resistance exercise program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two-arm parallel unblinded randomised designTwo-arm parallel unblinded randomised design
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Muscle function [12 weeks]

    Peak torque (Nm) of the shoulder and hip

Secondary Outcome Measures

  1. Body composition [12 weeks]

    Changes in fat mass and lean body mass

  2. Bone mineral density [12 weeks]

    Changes in bone mineral density

  3. Muscle thickness [12 weeks]

    Changes in muscle thickness

  4. Muscle protein synthesis [12 weeks]

    Rate of muscle protein synthesis

  5. Energy expenditure [12 weeks]

    Changes in energy expenditure rates

  6. Sleep Quality [12 weeks]

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

  7. Self reported quality of life [12 weeks]

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

  8. Physical activity levels [12 weeks]

    Changes in physical activity energy expenditure as measured using an accelerometer

  9. Exercise program acceptability [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 [12 weeks]

    Balance measured using the Y-balance test

  11. Changes in flexibility [12 weeks]

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

  12. Changes in cardiovascular risk markers [12 weeks]

    Changes in biochemical lipid profile

  13. Changes in diabetes risk markers [12 weeks]

    Changes in biochemical measures of HbA1c

Other Outcome Measures

  1. Sustainability of the exercise program through monitoring class attendance when unsupervised. [12 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Exeter Exeter United Kingdom EX1 2LT

Sponsors and Collaborators

  • University of Exeter
  • P.volve LLC

Investigators

  • Principal Investigator: Francis Stephens, University of Exeter

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Exeter
ClinicalTrials.gov Identifier:
NCT05397418
Other Study ID Numbers:
  • 2021-22-13
  • 309199
First Posted:
May 31, 2022
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Exeter

Study Results

No Results Posted as of May 31, 2022