Bariatric Surgery and Exercise Interventions: Effects on Muscle
June 18, 2024 updated by: University of Nottingham
Exploring the Short-Term Effect of Bariatric Surgery on Muscle Structure And Function; Followed By A Feasibility Assessment Of Exercise Intervention Post Bariatric Surgery
The purpose of this project is to assess the effects of bariatric surgery on muscle structure and function as well as investigating the feasibility of undertaking an exercise intervention post-surgery.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
A single-centre feasibility research programme based at the Royal Derby Hospital centre of the University of Nottingham.
This is an exploratory and feasibility study.
Muscle structure and function of 12 patients will be assessed before bariatric surgery and at 6 weeks, and then 10 weeks, after surgery.
After 6 weeks, participants will be randomised into two groups.
Group 1 will undergo a 4 week Resistance Exercise Training (RET).
Group 2 will undergo standard care procedure.
The total duration of programme we are aiming for is 13-14 weeks prior to bariatric surgery and exercise intervention for 4 weeks after bariatric surgery.
Study Type
Interventional
Enrollment (Estimated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Iskandar Idris
- Phone Number: 01332724605
- Email: iskandar.idris@nottingham.ac.uk
Study Contact Backup
- Name: Rebekah Wilmington
- Phone Number: 01332724605
- Email: rebekah.wilmington@nottingham.ac.uk
Study Locations
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Derby, United Kingdom
- Recruiting
- COMAP
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Contact:
- Rebekah Wilmington, BMBSBMedSci
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Obese adults (BMI greater than or equal to 35 kg/m2)
- Age range 18-70 years old
- Scheduled for RYGB surgery or sleeve gastrectomy surgery.
- Ability to give informed consent
Exclusion Criteria:
- Patients who are not fit or not suitable for RYGB or Sleeve Gastrectomy as per Tier 4 Bariatric Surgery MDT.
- For those high-risk patients who are fast tracked to surgery, we will exclude patients with a NYHA >3 or 4 heart failure status and those with end stage renal failure.
- BMI greater than or equal to 60
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Group 1 Resistance Exercise Therapy Feasibility
One group who have been randomised to receive 4 weeks of Resistance Exercise Therapy to explore the feasibility of introducing such a programme in the bariatric population.
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4 weeks of Resistance Exercise Therapy. This is a 4 week resistance exercise training programme that can be completed at home. The programme is designed to be progressive. It was designed by a bariatric physiotherapist and an exercise physiologist. This exercise programme will be discussed at the screening visit, educational material will be provided to the participants who are randomised to the intervention RET group. Safety advice will be given to each eligible participant to ensure that if they feel unwell, develop chest pain/tightness, then they must seek advice from GP/urgent care if necessary. The exercises will need to be performed at least three times a week. Compliance will be monitored with Fitbit downloads at each visit. Fitbits will be worn during exercise sessions only. |
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No Intervention: Group 2 Standard Care
This group have been randomised to receive standard care post surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To assess the effects of bariatric surgery on skeletal muscle ultrasound thickness.
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks
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This will be assessed using muscle ultrasound and units (mm)
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Total duration of study per participant is expected to be 13 to 14 weeks
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To assess the effects of bariatric surgery on skeletal muscle cross sectional area (cm2)
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks
|
This will be assessed using muscle ultrasound
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Total duration of study per participant is expected to be 13 to 14 weeks
|
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Assessment of percentage of patients who were retained throughout the intervention arm of the study
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks
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To be measured as percentage.
|
Total duration of study per participant is expected to be 13 to 14 weeks
|
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Assessment of percentage of patients who were compliant with the intervention arm of the study. To be guided by FitBit monitor use.
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks
|
This assessment will be measured as percentage of patients who met compliance targets with the intervention arm for the study.
|
Total duration of study per participant is expected to be 13 to 14 weeks
|
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Assessment of number of patients who were recruited to the study
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks
|
This assessment will be measured as a simple numeric value
|
Total duration of study per participant is expected to be 13 to 14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fasting glucose
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks, there will be bloods taken on each in-person study day. Plan is for 3 of these days, screening bloods will be reviewed from the NHS interface.
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These results will be undertaken by analysing blood samples taken by venepuncture of participants.
Units will be mmol .
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Total duration of study per participant is expected to be 13 to 14 weeks, there will be bloods taken on each in-person study day. Plan is for 3 of these days, screening bloods will be reviewed from the NHS interface.
|
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Skeletal muscle architecture (fibre length)
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks, ultrasounds will be performed at each in-person study day. performed on each in-person study day
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An ultrasound scan will be used for the purpose of this measurement.
Units (mm).
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Total duration of study per participant is expected to be 13 to 14 weeks, ultrasounds will be performed at each in-person study day. performed on each in-person study day
|
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Muscle fatigability (maximum voluntary contractions)
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks, each assessment for this outcome will take place at the in-person study days.
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This is the maximal force-generating capacity of a muscle or group of muscles
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Total duration of study per participant is expected to be 13 to 14 weeks, each assessment for this outcome will take place at the in-person study days.
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Lean body mass using BIA and D3 creatine
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks, each participant will be provided with the resources to facilitate these assessments at their in-person study days, urine collections will be returned later..
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These are stable biomarkers that have been previously used in research.
It acts in the body as creatine, which is a naturally occurring substance.
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Total duration of study per participant is expected to be 13 to 14 weeks, each participant will be provided with the resources to facilitate these assessments at their in-person study days, urine collections will be returned later..
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Motor control in force tracking
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
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As part of the Short Physical Performance Battery Test
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Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
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Balance using the Timed Up and Go (TUG) test
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
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As part of the Short Physical Performance Battery Test
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Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
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Balance in Gait and Motion testing
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
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As part of the Short Physical Performance Battery Test
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Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
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Hand grip strength
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
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The purpose of the handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles
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Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
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Predicted maximum oxygen consumption (VO2 max) in step box test
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
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As part of the Short Physical Performance Battery Test
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Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
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Skin fold and body circumference measurements
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
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To assess for any interval change
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Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
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Quality of life measurements using IPAQ questionnaire
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
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Questionnaires are performed to standardise the assessment of quality of life from the patient perspective.
IPAQ questionnaire contains open-ended questions surrounding individuals' last 7-day recall of physical activity
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Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
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insulin resistance (HOMA-IR)
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
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These results will be undertaken by analysing blood samples taken by venepuncture of participants.
Units will be nmol/L.
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Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
|
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Skeletal muscle architecture (pennation angle)
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
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An ultrasound scan will be used for the purpose of this measurement, units will be in degrees.
|
Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
|
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Quality of life measurements using SF-36 questionnaire
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
|
Questionnaires are performed to standardise the assessment of quality of life from the patient perspective.This questionnaire uses a likert scale as means of assessment.
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Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.
- Santa Mina D, Clarke H, Ritvo P, Leung YW, Matthew AG, Katz J, Trachtenberg J, Alibhai SM. Effect of total-body prehabilitation on postoperative outcomes: a systematic review and meta-analysis. Physiotherapy. 2014 Sep;100(3):196-207. doi: 10.1016/j.physio.2013.08.008. Epub 2013 Nov 13.
- Wadstrom C, Backman L, Forsberg AM, Nilsson E, Hultman E, Reizenstein P, Ekman M. Body composition and muscle constituents during weight loss: studies in obese patients following gastroplasty. Obes Surg. 2000 Jun;10(3):203-13. doi: 10.1381/096089200321643313.
- Alba DL, Wu L, Cawthon PM, Mulligan K, Lang T, Patel S, King NJ, Carter JT, Rogers SJ, Posselt AM, Stewart L, Shoback DM, Schafer AL. Changes in Lean Mass, Absolute and Relative Muscle Strength, and Physical Performance After Gastric Bypass Surgery. J Clin Endocrinol Metab. 2019 Mar 1;104(3):711-720. doi: 10.1210/jc.2018-00952.
- Haeffener MP, Ferreira GM, Barreto SS, Arena R, Dall'Ago P. Incentive spirometry with expiratory positive airway pressure reduces pulmonary complications, improves pulmonary function and 6-minute walk distance in patients undergoing coronary artery bypass graft surgery. Am Heart J. 2008 Nov;156(5):900.e1-900.e8. doi: 10.1016/j.ahj.2008.08.006. Epub 2008 Oct 5.
- Herring LY, Stevinson C, Carter P, Biddle SJH, Bowrey D, Sutton C, Davies MJ. The effects of supervised exercise training 12-24 months after bariatric surgery on physical function and body composition: a randomised controlled trial. Int J Obes (Lond). 2017 Jun;41(6):909-916. doi: 10.1038/ijo.2017.60. Epub 2017 Mar 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
May 30, 2022
First Submitted That Met QC Criteria
October 3, 2022
First Posted (Actual)
October 6, 2022
Study Record Updates
Last Update Posted (Actual)
June 20, 2024
Last Update Submitted That Met QC Criteria
June 18, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 22012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan to do so
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.