Body composition and muscle constituents during weight loss: studies in obese patients following gastroplasty.
C Wadström, L Backman, A M Forsberg...
https://pubmed.ncbi.nlm.nih.gov/10932257Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID05569785
Exploring the Short-Term Effect of Bariatric Surgery on Muscle Structure and Function and Assessing Exercise Intervention Feasibility After Surgery
Led by University of Nottingham · Updated on 2024-06-20
12
Participants Needed
1
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults with obesity who are scheduled for bariatric surgery to understand how the surgery affects muscle structure and function. This exploratory and feasibility study, based at the University of Nottingham, involves 12 patients and aims to assess changes before surgery, and at 6 and 10 weeks after surgery. The study also explores the possibility of adding an exercise program after surgery to improve outcomes. Participants will be randomly assigned six weeks after surgery to one of two groups. One group will take part in a 4-week home-based Resistance Exercise Training program designed by specialists, with exercises performed at least three times per week and monitored using Fitbit devices. The other group will receive standard care after surgery. The entire study period for each participant is about 13 to 14 weeks, including pre-surgery assessments and post-surgery interventions. Throughout the study, participants will undergo various assessments including muscle ultrasound measurements, blood tests, muscle strength and balance tests, body composition measurements, and quality of life questionnaires. Researchers will also monitor participants’ compliance with the exercise program and retention rates. These evaluations will take place during in-person study visits scheduled before surgery and at multiple points afterward to track progress and safety.
CONDITIONS
Brief Title
Bariatric Surgery and Exercise Interventions: Effects on Muscle
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Obesity with a body mass index (BMI) of 35 or higher
- Scheduled for Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy surgery
- Able to give informed consent
You will not qualify if you...
- Not fit or unsuitable for RYGB or sleeve gastrectomy as determined by the bariatric surgery medical team
- Severe heart failure with NYHA classification greater than 3
- End-stage kidney failure
- Body mass index (BMI) of 60 or higher
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.
1 screening and enrollment visit
Pre-Surgery Assessment
Duration - Up to 13 to 14 weeks prior to surgery
Participants undergo assessments of muscle structure and function before bariatric surgery.
1 baseline visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Surgery day and immediate recovery period
Participants undergo bariatric surgery including Roux-en-Y gastric bypass or sleeve gastrectomy and receive immediate post-operative care.
1 surgery visit (in-person)
Post-Surgery Assessment
Duration - 10 weeks post-surgery
Participants are assessed at 6 weeks and 10 weeks after surgery to evaluate muscle structure and function.
2 follow-up visits (in-person) at 6 and 10 weeks post-surgery
Exercise Intervention or Standard Care
Duration - 4 weeks
Participants are randomized at 6 weeks post-surgery to either a 4-week home-based resistance exercise training program or standard care to assess feasibility and effects on muscle.
Visits at least 3 times a week for exercise sessions; compliance monitored with Fitbit downloads at each visit
Trial Site Locations
Total: 1 location
1
COMAP
Derby, United Kingdom
Actively Recruiting
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Research Team
I
Iskandar Idris
R
Rebekah Wilmington
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Changes in Lean Mass, Absolute and Relative Muscle Strength, and Physical Performance After Gastric Bypass Surgery.
Diana L Alba, Lucy Wu, Peggy M Cawthon...
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Chao Li, Francesco Carli, Lawrence Lee...
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D Santa Mina, H Clarke, P Ritvo...
https://pubmed.ncbi.nlm.nih.gov/24439570The effects of supervised exercise training 12-24 months after bariatric surgery on physical function and body composition: a randomised controlled trial.
L Y Herring, C Stevinson, P Carter...
https://pubmed.ncbi.nlm.nih.gov/28262676