Female Muscle Enhancement

NCT ID: NCT05397418

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-11-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Muscle Function

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm parallel unblinded randomised design
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

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

Group Type EXPERIMENTAL

Supervised resistance exercise program

Intervention Type BEHAVIORAL

12 week supervised low impact resistance training program

Unsupervised resistance exercise program

Intervention Type BEHAVIORAL

12 week unsupervised low impact resistance training program

Control group

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

Group Type SHAM_COMPARATOR

Unsupervised resistance exercise program

Intervention Type BEHAVIORAL

12 week unsupervised low impact resistance training program

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Supervised resistance exercise program

12 week supervised low impact resistance training program

Intervention Type BEHAVIORAL

Unsupervised resistance exercise program

12 week unsupervised low impact resistance training program

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

P.volve LLC

UNKNOWN

Sponsor Role collaborator

University of Exeter

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Francis Stephens

Role: PRINCIPAL_INVESTIGATOR

University of Exeter

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Exeter

Exeter, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Svensen E, Koscien CP, Alamdari N, Wall BT, Stephens FB. A Novel Low-Impact Resistance Exercise Program Increases Strength and Balance in Females Irrespective of Menopause Status. Med Sci Sports Exerc. 2025 Mar 1;57(3):501-513. doi: 10.1249/MSS.0000000000003586. Epub 2024 Nov 6.

Reference Type DERIVED
PMID: 39480197 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

309199

Identifier Type: OTHER

Identifier Source: secondary_id

2021-22-13

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Living Independence Through Functional Training
NCT07125378 RECRUITING PHASE1/PHASE2