Bariatric Surgery Candidate, Obesity
Conditions
Keywords
resistance exercise therapy
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.
Interventions
OTHERResistance 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.
Sponsors
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
A single-centre feasibility research programme
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the effects of bariatric surgery on skeletal muscle ultrasound thickness. | Total duration of study per participant is expected to be 13 to 14 weeks | This will be assessed using muscle ultrasound and units (mm) |
| To assess the effects of bariatric surgery on skeletal muscle cross sectional area (cm2) | Total duration of study per participant is expected to be 13 to 14 weeks | This will be assessed using muscle ultrasound |
| Assessment of percentage of patients who were retained throughout the intervention arm of the study | Total duration of study per participant is expected to be 13 to 14 weeks | To be measured as percentage. |
| Assessment of percentage of patients who were compliant with the intervention arm of the study. To be guided by FitBit monitor use. | 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. |
| Assessment of number of patients who were recruited to the study | Total duration of study per participant is expected to be 13 to 14 weeks | This assessment will be measured as a simple numeric value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Balance using the Timed Up and Go (TUG) 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. | As part of the Short Physical Performance Battery Test |
| Balance in Gait and Motion testing | 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. | As part of the Short Physical Performance Battery Test |
| Hand grip strength | 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. | The purpose of the handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles |
| Predicted maximum oxygen consumption (VO2 max) in step box 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. | As part of the Short Physical Performance Battery Test |
| Fasting glucose | 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. | These results will be undertaken by analysing blood samples taken by venepuncture of participants. Units will be mmol . |
| Quality of life measurements using IPAQ questionnaire | 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. IPAQ questionnaire contains open-ended questions surrounding individuals' last 7-day recall of physical activity |
| insulin resistance (HOMA-IR) | 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. | These results will be undertaken by analysing blood samples taken by venepuncture of participants. Units will be nmol/L. |
| Skeletal muscle architecture (pennation angle) | 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. | An ultrasound scan will be used for the purpose of this measurement, units will be in degrees. |
| Quality of life measurements using SF-36 questionnaire | 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. |
| Skin fold and body circumference measurements | 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. | To assess for any interval change |
| Skeletal muscle architecture (fibre length) | 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 | An ultrasound scan will be used for the purpose of this measurement. Units (mm). |
| Muscle fatigability (maximum voluntary contractions) | 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. | This is the maximal force-generating capacity of a muscle or group of muscles |
| Lean body mass using BIA and D3 creatine | 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.. | These are stable biomarkers that have been previously used in research. It acts in the body as creatine, which is a naturally occurring substance. |
| Motor control in force tracking | 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. | As part of the Short Physical Performance Battery Test |
Countries
United Kingdom
Contacts
Primary ContactIskandar Idris
Backup ContactRebekah Wilmington
Outcome results
None listed