A Novel Low-Impact Resistance Exercise Program Increases Strength and Balance in Females Irrespective of Menopause Status.
Erika Svensen, Christopher P Koscien, Nima Alamdari...
https://pubmed.ncbi.nlm.nih.gov/39480197Actively Recruiting
Phase Not Applicable
Age: 25Years - 50Years
FEMALE
Healthy Volunteers
ID07457437
Effect of a Progressive Resistance Exercise Program on Muscle Mass and Physical Function During a Tirzepatide Induced Weight Loss in Overweight and Obese Females: a Randomised Parallel Group Study
Led by University of Exeter · Updated on 2026-03-27
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying overweight and obese females aged 25 to 50 to see how a structured, progressive resistance exercise program affects muscle mass and physical function during weight loss induced by tirzepatide, a drug that acts on GLP-1 and GIP receptors. The study aims to address concerns about muscle loss related to these medications and to explore if exercise can help preserve muscle mass during and after weight loss. Participants will be divided into pre and peri menopausal groups to examine if menopause influences these outcomes. Participants will receive tirzepatide over 20 weeks, starting at 2.5 mg per week with dose increases every four weeks, following standard guidelines. One group will also follow a progressive resistance exercise program consisting of low-impact, whole-body training four times a week, led by video and supervised by researchers. The control group will continue their usual physical activity. The study includes baseline, weekly, four-weekly, mid, post, and follow-up visits at 40 and 72 weeks to assess ongoing effects after stopping treatment. Throughout the study, muscle mass will be measured using ultrasound and a D3-Creatine tracer method to directly assess skeletal muscle. Strength and physical function tests include dynamometry, sit-to-stand, grip strength, and balance assessments. Body composition, diet, gastrointestinal symptoms, quality of life, and sleep will also be monitored using various tools and questionnaires. Participants will report their body mass daily and attend regular lab visits for blood tests and other assessments. A subset will have muscle biopsies for detailed analysis. Follow-up visits will help understand long-term changes after stopping tirzepatide.
CONDITIONS
Brief Title
Function and Lean Mass Preservation With Resistance Exercise During a GLP-1RA Treatment
Who Can Participate
Age: 25Years - 50Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Female aged between 25 and 50 years
- BMI of 27 kg/m2 or higher with one obesity-related co-morbidity
- Or BMI between 30 and 35 kg/m2
You will not qualify if you...
- Previous use of GLP-1 receptor agonist medications
- Diagnosis of Type 1 or Type 2 diabetes
- Health conditions that contraindicate GLP-1/GIP treatment
- Failure to pass clinical health screening for tirzepatide prescription
- Pregnant or planning pregnancy within 6 months
- History of eating disorder
- Unable to perform the exercise program and tests
- Advised against exercise by a healthcare professional
- Current or recent injury in the last 6 months affecting exercise ability
- Regular resistance training exceeding 10 sessions per year
- Using medications or supplements affecting muscle mass or function in the last 6 months
- Current or recent smoker within 6 months
- Currently on hormone replacement therapy (HRT)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 20 weeks
Participants receive a 20-week tirzepatide treatment. Some participants also engage in a progressive resistance exercise program with supervised sessions up to 4 times a week.
Weekly visits to the laboratory for assessments; exercise sessions up to 4 times per week for the exercise group.
Follow-up
Duration - Up to 52 weeks after treatment ends
Participants return for follow-up testing at 40 and 72 weeks to assess body composition and physical function after stopping treatment.
2 follow-up visits at weeks 40 and 72
Trial Site Locations
Total: 1 location
1
Nutritional Physiology Research Unit
Exeter, Devon, United Kingdom, EX2 4TH
Actively Recruiting
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Research Team
T
Thomas P J Kennedy, MSc
S
Sarah K Graham, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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Published Research Related To This Trial
Effect of a high protein diet and/or resistance exercise on the preservation of fat free mass during weight loss in overweight and obese older adults: a randomized controlled trial.
Amely M Verreijen, Mariëlle F Engberink, Robert G Memelink...
https://pubmed.ncbi.nlm.nih.gov/28166780Body composition changes during weight reduction with tirzepatide in the SURMOUNT-1 study of adults with obesity or overweight.
Michelle Look, Julia P Dunn, Robert F Kushner...
https://pubmed.ncbi.nlm.nih.gov/39996356A Review of the Effects of Glucagon-Like Peptide-1 Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors on Lean Body Mass in Humans.
Jack Alistair Sargeant, Joseph Henson, James Adam King...
https://pubmed.ncbi.nlm.nih.gov/31565876Tirzepatide Once Weekly for the Treatment of Obesity.
Ania M Jastreboff, Louis J Aronne, Nadia N Ahmad...
https://pubmed.ncbi.nlm.nih.gov/35658024