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.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
12
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.
COMAP
Derby, United Kingdom
RECRUITINGTo assess the effects of bariatric surgery on skeletal muscle ultrasound thickness.
This will be assessed using muscle ultrasound and units (mm)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Total duration of study per participant is expected to be 13 to 14 weeks
Fasting glucose
These results will be undertaken by analysing blood samples taken by venepuncture of participants. Units will be mmol .
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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Skeletal muscle architecture (fibre length)
An ultrasound scan will be used for the purpose of this measurement. Units (mm).
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
Muscle fatigability (maximum voluntary contractions)
This is the maximal force-generating capacity of a muscle or group of muscles
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.
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.
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..
Motor control in force tracking
As part of the Short Physical Performance Battery 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.
Balance using the Timed Up and Go (TUG) test
As part of the Short Physical Performance Battery 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.
Balance in Gait and Motion testing
As part of the Short Physical Performance Battery 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.
Hand grip strength
The purpose of the handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles
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.
Predicted maximum oxygen consumption (VO2 max) in step box test
As part of the Short Physical Performance Battery 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.
Skin fold and body circumference measurements
To assess for any interval change
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.
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
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.
insulin resistance (HOMA-IR)
These results will be undertaken by analysing blood samples taken by venepuncture of participants. Units will be nmol/L.
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.
Skeletal muscle architecture (pennation angle)
An ultrasound scan will be used for the purpose of this measurement, units will be in degrees.
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.
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.
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.