Bariatric Surgery CandidateNCT05569785
Bariatric Surgery and Exercise Interventions: Effects on Muscle
A study testing Resistance Exercise Therapy in people with Bariatric Surgery Candidate and Obesity, run by University of Nottingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bariatric Surgery Candidate, Obesity
- What is being tested?
- Resistance Exercise Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
COMAP
Derby
Rebekah Wilmington, BMBSBMedSci
About this study
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
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.
Read the 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.
- Conditions
- Bariatric Surgery Candidate, Obesity
- Being tested
- Resistance Exercise Therapy
- Keywords
- resistance exercise therapy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Exercise TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Resistance Exercise Therapy Feasibility | Active comparator | 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. Receives: Other: Resistance Exercise Therapy |
| Group 2 Standard Care | No intervention | This group have been randomised to receive standard care post surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effects of bariatric surgery on skeletal muscle ultrasound thickness.
This will be assessed using muscle ultrasound and units (mm)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Total duration of study per participant is expected to be 13 to 14 weeks
Secondary outcomes (14)
Fasting glucose
These results will be undertaken by analysing blood samples taken by venepuncture of participants. Units will be mmol .
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Mar 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-centre feasibility research programme
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569785
- Sponsor's protocol ID
- 22012
- Status last verified
- Jun 2024
- First submitted
- 30 May 2022
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to do so
Publications
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.
PubMed 10932257Alba 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.
PubMed 30657952Haeffener 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.
PubMed 19061704Li 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.
PubMed 23052535Santa 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.
PubMed 24439570Herring 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.
PubMed 28262676
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05569785
- Acronym / sponsor ID
- 22012
- Conditions
- Bariatric Surgery Candidate, Obesity
- Keywords
- resistance exercise therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A single-centre feasibility research programme
| Arm | Type | Receives |
|---|---|---|
| Group 1 Resistance Exercise Therapy Feasibility | Active comparator | Other: Resistance Exercise TherapyOne 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. |
| Group 2 Standard Care | No intervention | –This group have been randomised to receive standard care post surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Exercise Therapy4 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. | Other | Group 1 Resistance Exercise Therapy Feasibility |
Primary outcome
To assess the effects of bariatric surgery on skeletal muscle ultrasound thickness.
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Total duration of study per participant is expected to be 13 to 14 weeks
This assessment will be measured as a simple numeric value
14 secondary outcomes
Fasting glucose
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.
Skeletal muscle architecture (fibre length)
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)
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
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
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
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
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
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
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
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
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)
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)
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Background: PubMed 10932257Wadstrom 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.
- Background: PubMed 30657952Alba 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.
- Background: PubMed 19061704Haeffener 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.
- Background: PubMed 23052535Li 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.
- Background: PubMed 24439570Santa 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.
- Background: PubMed 28262676Herring 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.
- Individual participant dataSharing planned: No. No plan to do so
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise Therapy in people with Bariatric Surgery Candidate and Obesity, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iskandar Idris (01332724605, iskandar.idris@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effects of bariatric surgery on skeletal muscle ultrasound thickness. (time frame: Total duration of study per participant is expected to be 13 to 14 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05569785, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.