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Completed

NCT Number: NCT07095322

Investigating the Feasibility and Acceptability of Co-created Intervention to Improve Women's Participation in Muscle-strengthening Exercises

This study will utilise the Randomised Controlled Trial (RCT) design. Following completion of the baseline measurements, participants will be randomly assigned to either the control group or the intervention group.

Control Group Control group will be asked to maintain normal activity levels for 24 weeks. On completion of the 24 weeks, 12-week University of Glasgow Sports gym membership will be given.

Intervention Group The overall aim of the intervention is for participants to participate in muscle strengthening exercises, of choice, two days a week. These exercises can include weight machine, resistance band and body weight resistance exercises, alongside strength training classes such as yoga and body pump. The intervention will begin with weekly education sessions over the first 4 weeks, to help make sure participants are confident and competent in performing exercises. Participants will be given a gym membership for the 12-week intervention period and asked to log all muscle strengthening exercises that participants participate in. Throughout the intervention, participants will receive weekly support reminder messages via WhatsApp from the research team, and researcher will also set up a social support group on WhatsApp for the participants. Weekly group-based exercise sessions with the researcher will also be offered to the participants; these will be optional.

The following data will be collected from all participants. All measures will be collected at baseline, mid-intervention measurement (week 6), post-intervention (week 12), and follow-up (week 24) except for follow-up interview and participants will be given an Amazon voucher worth £25 for every measurement period attend. Each test/measure is detailed further below.

During baseline measurement, researcher will ask the participants on their age, postcode, ethnic background, work situation, highest qualification completed, marital status, caregiver or not and the rating of health. Following this researcher will measure participants' body composition where the weight, height, fat mass, fat percentages, muscle mass and muscle size will be recorded.

Muscular strength will be measured using three strength tests which are the grip strength test, back strength test and maximal voluntary contraction. Participants will be shown how to perform the test by the research team before performing it. Participants will be asked to do each test 3 times with rest in between each attempt. The body composition and strength test will be conducted again in week 6, 12 and 24.

Intervention group will be involved in a follow-up interview during the measurement visit on week 12 and 24 to discuss the experiences and feedback on the intervention with the researchers.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Glasgow

Glasgow, G12 *QQ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • female
  • between 18-45 years old
  • living in Glasgow area
  • not currently achieving the government recommendation of 2 days a week of muscle-strengthening activities

Exclusion criteria

  • did not pass the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)
  • have blood pressure > 150/90 mmhg
  • currently pregnant, planning to get pregnant within the next 6 months or in post-partum period in the past 6 months
  • have intellectual disabilities

Treatment and study plan

Strength Education Session

Behavioral

Strength education session given at the first 4 weeks of intervention to educate women on muscle-strengthening exercises

Other names: Education

Gym Membership

Behavioral

12 weeks gym membership to allow participant to go to the gym on their own

Group Exercise Session

Behavioral

Optional exercise sessions from week 4 to week 12 of the intervention if the participants want to join

Other names: Exercise session

Training Log

Behavioral

To record the exercise done for 24 weeks duration. Consist of date, day, exercise, set, repetitions, load, RPE

Other names: Log

Support group

Behavioral

For reminders and support for the participant for the first 12 weeks of intervention

Primary outcomes

  1. Interview with researcher on the feasibility and acceptability of the co-created intervention.

    Time frame: Week 12 (post intervention) - how they find the intervention Week 24 (follow up) - to see if they still continue participating in muscle-strengthening exercises, were there any challenges and what has helped them

    Participants is invited to an interview with the researcher to discuss their opinion of the intervention component and if it has helps them to start and continue participating in muscle-strengthening exercises. Interview conducted at two time point week 12 and week 24. Interview will be conducted either in-person or online through Microsoft Teams and will be audio recorded for analysis purpose.

Secondary outcomes

  1. Knee Extensor Strength

    Time frame: changes from baseline to week 6, 12 and 24

    Knee extensor maximal torque during isometric MVC

  2. Grip Strength

    Time frame: Changes from baseline to week 6, 12 and 24

    measured via handgrip dynamometer

  3. Back Strength

    Time frame: Changes from baseline to week 6, 12 and 24

    measured via back strength dynamometer

  4. Vastus lateralis muscle thickness

    Time frame: Changes from baseline to week 6, 12 and 24

    measured via ultrasound

  5. Height

    Time frame: Recorded at baseline (Week 0)

    Height recorded using a stadiometer in centimetre at the beginning of the study.

  6. Bodyweight

    Time frame: Changes from baseline to week 6, and 24.

    Changes in bodyweight, recorded in kilogram. Measured via body composition analyser

  7. Body Mass Index (BMI)

    Time frame: Changes from baseline to week 6, 12, and 24

    Will be calculated from the bodyweight (in kilogram) and height (in meter) according to the BMI formula (kg/m^2).

  8. Body Fat Mass

    Time frame: Changes from baseline to week 6, 12 and 24.

    Changes in body fat mass, recorded in kilogram. Measured via body composition analyser

  9. Body Fat Percentages

    Time frame: Changes from baseline to week 6, 12, and 24

    Changes in body fat percentage, recorded in percentage. Measured via body composition analyser

  10. Fat Free Mass

    Time frame: Changes from baseline to week 6, 12, and 24

    Changes in fat free mass, recorded in kilogram. Measured via body composition analyser

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Registry information

Official study title

Women in Strength: A Randomised Pilot Feasibility Trial of a Muscle Strengthening Exercise Intervention for Women

Acronym: WISH

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

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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