Bariatric Surgery and Exercise Interventions: Effects on Muscle

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-12-01

Brief Summary

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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.

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Detailed Description

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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

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Bariatric Surgery Candidate Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A single-centre feasibility research programme

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Resistance Exercise Therapy

Intervention Type 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 2 Standard Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No