Bariatric Surgery and Exercise Interventions: Effects on Muscle

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bariatric Surgery Candidate, Obesity

Intervention / Treatment
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* Other: Resistance Exercise Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A single-centre feasibility research programme
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 Resistance Exercise Therapy Feasibility<br>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. | Other: Resistance Exercise Therapy<br>* 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.<br>|
| No Intervention: Group 2 Standard Care<br>This group have been randomised to receive standard care post surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 | 
| 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. | 
| 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.. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resistance exercise therapy