Bariatric Surgery and Exercise Interventions: Effects on Muscle

June 18, 2024 updated by: University of Nottingham

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Derby, United Kingdom
        • Recruiting
        • COMAP
        • Contact:
          • Rebekah Wilmington, BMBSBMedSci

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1 Resistance Exercise Therapy Feasibility
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

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.
No Intervention: Group 2 Standard Care
This group have been randomised to receive standard care post surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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)
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks
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
Time Frame: Total duration of study per participant is expected to be 13 to 14 weeks
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.
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.
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
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
Total duration of study per participant is expected to be 13 to 14 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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)
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
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)
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.
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
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..
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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)
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.
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)
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nottingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to do so

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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