NCT05397418

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2023

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

1.6 years

First QC Date

January 13, 2022

Last Update Submit

June 10, 2024

Conditions

Muscle Function

Keywords

Muscle functionFemalesResistance exercise

Outcome Measures

Primary Outcomes (1)

  • Muscle function

    Peak torque (Nm) of the shoulder and hip

    12 weeks

Secondary Outcomes (13)

  • Body composition

    12 weeks

  • Bone mineral density

    12 weeks

  • Muscle thickness

    12 weeks

  • Muscle protein synthesis

    12 weeks

  • Energy expenditure

    12 weeks

  • +8 more secondary outcomes

Other Outcomes (1)

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

    12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Supervised resistance exercise programBehavioral: Unsupervised resistance exercise program

Control group

SHAM COMPARATOR

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

Behavioral: Unsupervised resistance exercise program

Interventions

Supervised resistance exercise programBEHAVIORAL

12 week supervised low impact resistance training program

Intervention group
Unsupervised resistance exercise programBEHAVIORAL

12 week unsupervised low impact resistance training program

Control groupIntervention group

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter

Exeter, EX1 2LT, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 39480197DERIVED

Study Officials

  • Francis Stephens

    University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Two-arm parallel unblinded randomised design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2022

First Posted

May 31, 2022

Study Start

May 1, 2022

Primary Completion

November 23, 2023

Study Completion

November 23, 2023

Last Updated

June 11, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)