Bariatric Surgery and Exercise Interventions: Effects on Muscle

Obesity Clinical Trial

Official title:

Exploring the Short-Term Effect of Bariatric Surgery on Muscle Structure And Function; Followed By A Feasibility Assessment Of Exercise Intervention Post Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05569785
• Other study ID #: 22012
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2024
• Source: University of Nottingham
• Contact: Iskandar Idris
• Phone: 01332724605
• Email: iskandar.idris[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 1, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity

Intervention

Other:
• Resistance Exercise Therapy
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.

Locations

Country	Name	City	State
United Kingdom	COMAP	Derby

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effects of bariatric surgery on skeletal muscle ultrasound thickness.	This will be assessed using muscle ultrasound and units (mm)	Total duration of study per participant is expected to be 13 to 14 weeks
Primary	To assess the effects of bariatric surgery on skeletal muscle cross sectional area (cm2)	This will be assessed using muscle ultrasound	Total duration of study per participant is expected to be 13 to 14 weeks
Primary	Assessment of percentage of patients who were retained throughout the intervention arm of the study	To be measured as percentage.	Total duration of study per participant is expected to be 13 to 14 weeks
Primary	Assessment of percentage of patients who were compliant with the intervention arm of the study. To be guided by FitBit monitor use.	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
Primary	Assessment of number of patients who were recruited to the study	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	Fasting glucose	These results will be undertaken by analysing blood samples taken by venepuncture of participants. Units will be mmol .	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.
Secondary	Skeletal muscle architecture (fibre length)	An ultrasound scan will be used for the purpose of this measurement. Units (mm).	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
Secondary	Muscle fatigability (maximum voluntary contractions)	This is the maximal force-generating capacity of a muscle or group of muscles	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.
Secondary	Lean body mass using BIA and D3 creatine	These are stable biomarkers that have been previously used in research. It acts in the body as creatine, which is a naturally occurring substance.	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..
Secondary	Motor control in force tracking	As part of the Short Physical Performance Battery Test	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.
Secondary	Balance using the Timed Up and Go (TUG) test	As part of the Short Physical Performance Battery Test	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.
Secondary	Balance in Gait and Motion testing	As part of the Short Physical Performance Battery Test	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.
Secondary	Hand grip strength	The purpose of the handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles	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.
Secondary	Predicted maximum oxygen consumption (VO2 max) in step box test	As part of the Short Physical Performance Battery Test	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.
Secondary	Skin fold and body circumference measurements	To assess for any interval change	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.
Secondary	Quality of life measurements using IPAQ questionnaire	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	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.
Secondary	insulin resistance (HOMA-IR)	These results will be undertaken by analysing blood samples taken by venepuncture of participants. Units will be nmol/L.	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.
Secondary	Skeletal muscle architecture (pennation angle)	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.
Secondary	Quality of life measurements using SF-36 questionnaire	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.	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.