Function and Lean Mass Preservation With Resistance Exercise During a GLP-1RA Treatment

What this study is testing ClinicalTrials.gov NCT07457437 ↗

Description as written by the study sponsor.

This study aims to investigate the effect that a structured, progressive resistance exercise program may have on maintaining the muscle mass and physical function of overweight/ obese females whilst they experience a tirzepatide (GLP-1/GIP receptor agonist) induced weight loss. Overweight and obese females aged 25-50 will be recruited for the study, they will require a BMI of \>30 or \>27 with one obesity related comorbidity (excluding diabetes). They will be screened, prescribed tirzepatide and then randomly assigned to either the intervention (GLP-1/GIP + Exercise) or the control group (GLP-1/GIP). Groups will then be split into pre and peri menopausal groups to provide a further exploratory pathway looking analysing if the menopause transition may have any effect on our outcome variables. This was proposed as in the UK females are more likely to begin GLP-1RA treatment. Both groups will be given an industry standard treatment of tirzepatide over 20 weeks starting at a dose of 2.5mg/week and following the dose titration process of +2.5mg/week every four weeks outlined by its manufacturers. The Exercise Group (GLP-1 +EXC) will be given the same tirzepatide prescription alongside following a progressive resistance exercise program. The exercise program will follow a similar structure to previous work in which participants will complete a propriety 20-wk whole body, low impact resistance exercise training program four times a week. The exercise sessions will be up to an hour and will be instructor lead by video and supervised by a member of the research team at The University of Exeter.

Treatments tested

• Progressive Resistance Exercise Training Program Other

  Participants in the GLP-1 + Exc group will participate in a 20 Week Progressive Resistance Exercise Training Program. This will be a low impact training program created by PVolve LLC. The plan will increase in session frequency and volume reaching 4 sessions per week at week 4 up until week 20 and will comprise of mostly banded, weighted or bodyweight exercises with small high intensity interval sessions after some of the sessions. Participants will attend the exercise classes on site at the St Luke's campus which will be delivered by PVolve instructors via video demonstration. Classes will be supervised by a member of the research team at all times.

• Habitual physical activity guidelines Other

  Control group consisting of continuing habitual physical activity guidelines for 20 weeks