Bariatric Surgery and Exercise Interventions: Effects on Muscle

NCT05569785 | Recruiting

• 1 other identifier: 22012
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate; Obesity

Keywords

resistance exercise therapy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (14)

• 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.

• 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

• 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.

• 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..

• 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.

Study Arms (2)

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.

Other: Resistance Exercise Therapy

Group 2 Standard Care

NO INTERVENTION

This group have been randomised to receive standard care post surgery.

Interventions

Resistance Exercise Therapy OTHER

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.

Group 1 Resistance Exercise Therapy Feasibility

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

COMAP

Derby, United Kingdom

RECRUITING

Related Publications (6)

• 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.

  PMID: 10932257 BACKGROUND

• Alba 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.

  PMID: 30657952 BACKGROUND

• Haeffener 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.

  PMID: 19061704 BACKGROUND

• Li 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.

  PMID: 23052535 BACKGROUND

• 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.

  PMID: 24439570 BACKGROUND

• 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.

  PMID: 28262676 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Iskandar Idris

CONTACT

01332724605; iskandar.idris@nottingham.ac.uk

Rebekah Wilmington

CONTACT

01332724605; rebekah.wilmington@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-centre feasibility research programme

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: October 6, 2022
• Study Start: March 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 1, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)