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

NCT07095322 | Completed DMC

• 1 other identifier: WISH
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Physical Activities; Exercise; Muscular Strength; Healthy Women

Keywords

Exercise; Muscle-strengthening; Women; Co-creation; co-design intervention; WISH study

Outcome Measures

Primary Outcomes (1)

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

  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.

  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

Secondary Outcomes (10)

• Knee Extensor Strength

  changes from baseline to week 6, 12 and 24

• Grip Strength

  Changes from baseline to week 6, 12 and 24

• Back Strength

  Changes from baseline to week 6, 12 and 24

• Vastus lateralis muscle thickness

  Changes from baseline to week 6, 12 and 24

• Height

  Recorded at baseline (Week 0)

Study Arms (2)

Control

NO INTERVENTION

Remain usual activity level

Intervention

EXPERIMENTAL

Participated in the co-created intervention

Behavioral: Strength Education Session; Behavioral: Gym Membership; Behavioral: Group Exercise Session; Behavioral: Training Log; Behavioral: Support group

Interventions

Strength Education Session BEHAVIORAL

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

Also known as: Education

Intervention

Gym Membership BEHAVIORAL

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

Intervention

Group Exercise Session BEHAVIORAL

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

Also known as: Exercise session

Intervention

Training Log BEHAVIORAL

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

Also known as: Log

Intervention

Support group BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

University of Glasgow

Glasgow, G12 *QQ, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Educational Status; Self-Help Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Organizations; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Stuart Gray

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 31, 2025
• Study Start: December 4, 2024
• Primary Completion: July 7, 2025
• Study Completion: July 7, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)