Clinical trial NCT05569785: Bariatric Surgery and Exercise Interventions: Effects on Muscle
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bariatric Surgery Candidate
Obesity
Keywords: resistance exercise therapy
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-centre feasibility research programme
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess the effects of bariatric surgery on skeletal muscle ultrasound thickness.
timeFrame: Total duration of study per participant is expected to be 13 to 14 weeks
measure: To assess the effects of bariatric surgery on skeletal muscle cross sectional area (cm2)
timeFrame: Total duration of study per participant is expected to be 13 to 14 weeks
measure: Assessment of percentage of patients who were retained throughout the intervention arm of the study
timeFrame: Total duration of study per participant is expected to be 13 to 14 weeks
measure: Assessment of percentage of patients who were compliant with the intervention arm of the study. To be guided by FitBit monitor use.
timeFrame: Total duration of study per participant is expected to be 13 to 14 weeks
measure: Assessment of number of patients who were recruited to the study
timeFrame: Total duration of study per participant is expected to be 13 to 14 weeks
Secondary outcomes:
measure: Fasting glucose
timeFrame: 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.
measure: Skeletal muscle architecture (fibre length)
timeFrame: 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
measure: Muscle fatigability (maximum voluntary contractions)
timeFrame: 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.
measure: Lean body mass using BIA and D3 creatine
timeFrame: 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..
measure: Motor control in force tracking
timeFrame: 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.
measure: Balance using the Timed Up and Go (TUG) test
timeFrame: 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.
measure: Balance in Gait and Motion testing
timeFrame: 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.
measure: Hand grip strength
timeFrame: 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.
measure: Predicted maximum oxygen consumption (VO2 max) in step box test
timeFrame: 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.
measure: Skin fold and body circumference measurements
timeFrame: 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.
measure: Quality of life measurements using IPAQ questionnaire
timeFrame: 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.
measure: insulin resistance (HOMA-IR)
timeFrame: 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.
measure: Skeletal muscle architecture (pennation angle)
timeFrame: 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.
measure: Quality of life measurements using SF-36 questionnaire
timeFrame: 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.
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: COMAP
Study officials:
References:
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.
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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.
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.