Does muscle strength and abdominal wall function improve with weight loss after gastric bypass?

• Register: ISRCTN
• Last refreshed on: 8 January 2024
• Main ID: ISRCTN17263619
• Date of registration: 15/03/2017
• Prospective Registration: No
• Primary sponsor: County Council of Västerbotten (Västerbottens läns landsting)
• Public title: Does muscle strength and abdominal wall function improve with weight loss after gastric bypass?
• Scientific title: Does muscle strength and abdominal wall function improve with weight loss after gastric bypass? A clinical observational study
• Date of first enrolment: 30/09/2016
• Target sample size: 100
• Recruitment status: Ongoing
• URL: https://www.isrctn.com/ISRCTN17263619
• Study type: Observational
• Study design: Clinical observational study and semi-structured interviews with qualitative content analysis (Treatment)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Ulf Gunnarsson

• Name: Jeff Wennerlund

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients eligible for primary laparoscopic gastric bypass
2. All patients undergoing primary laparoscopic gastric bypass at Lycksele Hospital are eligible for recruitment
3. Patients undergoing surgery in Uppsala are eligible for collection of blood and tissue samples only
4. All ages
Exclusion criteria: If, after inclusion, no or different surgery is planned

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Obesity, weight loss, muscle strength
Nutritional, Metabolic, Endocrine
Obesity

Intervention(s)

Current interventions as of 13/12/2023:
Blood samples are collected to analyze matrix metalloproteinases, hyaluron och associated biomarkers before surgery, as well as 1 month, 3 months, 6 months, plus 2 and 3 years after. Abdominal wall muscle and fascia biopsies are also collected during surgery for analysis. Abdominal wall and thigh strength are measured with the use of BioDex System 3 before, 6 months, and 3-6 years after gastric bypass. Physical ability and abdominal wall function are also measured using the Ventral Hernia Pain Questionnaire (VHPQ), International Physical Ability Questionnaire (IPAQ) and Visual Analog Scale for abdominal wall function (VAS), all once before, 6 months and 3-6 years after surgery.

Two qualitative interview studies using Qualitative Content Analysis designed to capture experiences of change of bodily function after weight loss induced by gastric bypass surgery. The first study will take place one to three years postoperatively and focus on the changes in physical activity. A later interview study 3 to 6 years after surgery will focus on abdominal wall function.

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Previous interventions as of 03/03/2022:

Blood samples are collected to analyze matrix metalloproteinases before surgery, as well as 2 weeks, 1 month, 3 months, 6 months, and 2 years after. Abdominal wall muscle and fascia biopsies are collected during surgery for analysis of matrix metalloproteinases. Abdominal wall and thigh strength are measured with the use of BioDex System 3 before and 6 months after gastric bypass. Physical ability and abdominal wall function are also measured using the Ventral Hernia Pain Questionnaire (VHPQ), International Physical Ability Questionnaire (IPAQ) and Visual Analog Scale for abdominal wall function (VAS), all once before and once

Primary Outcome(s)

Current primary outcome measure as of 13/12/2023:
1. Matrix metalloproteinases, hyaluron and associated biomarkers measured from blood samples taken at baseline (pre-operatively) and 1 month, 3 months, 6 months, and 2 and 3 years postoperatively
2. Abdominal wall and thigh muscle strength, measured with the BioDex System 3 at baseline (pre-operatively), 6 months and 3-6 years postoperatively
3. Physical ability and abdominal wall function, measured using the Ventral Hernia Pain Questionnaire (VHPQ), International Physical Activity Questionnaire (IPAQ), and Visual Analog Scale (VAS) for abdominal wall function at baseline (pre-operatively), 6 months and 3-6 years postoperatively
4. Semi-structured interviews describing the change in muscle strength, physical activity ability and abdominal wall function after gastric bypass surgery

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Previous primary outcome measure as of 03/03/2022:

1. Matrix metalloproteinases, measured from blood samples taken at baseline (pre-operatively) and 2 weeks, 1 month, 3 months, 6 months, and 2 years postoperatively
2. Abdominal wall and thigh muscle strength, measured with the BioDex System 3 at baseline (pre-operatively) and 6 months postoperatively
3. Physical ability and abdominal wall function, measured using the Ventral Hernia Pain Questionnaire (VHPQ), International Physical Activity Questionnaire (IPAQ), and Visual Analog Scale (VAS) for abdominal wall function at baseline (pre-operatively) and 6 months postoperatively
4. Semi-structured interviews describing the change in muscle strength and physical activity ability after gastric bypass surgery

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Previous primary outcome measure as of 21/04/2020:

1. Matrix metalloproteinases, measured from blood samples taken at baseline (pre-operatively) and 2 weeks, 1 month, 3 months, 6 months, and 2 years postoperatively
2. Abdominal wall and thigh muscle strength, measured with the BioDex System 3 at baseline (pre-operatively) and 6 months post-operatively
3. Physical ability and abdominal wall function, measured using the Ventral Hernia Pain Questionnaire (VHPQ), International Physical Activity Questionnaire (IPAQ), and Visual Analog Scale (VAS) for abdominal wall function at baseline (pre-operatively) and 6 months postoperatively

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Previous primary outcome measure:

1. Matrix metalloproteinases, measured from blood samples taken at baseline (pre-operatively) and 2 weeks, 1 month, 3 months and 6 months postoperatively
2. Abdominal wall and thigh muscle strength, measured with the BioDex System 3 at baseline (pre-operatively) and 6 months post-operatively
3. Physical ability and abdominal wall function, measured using the Ventral Hernia Pain Questionnaire (VHPQ), International Physical Activity Questionnaire (IPAQ), and Visual Analog Scale (VAS) for abdominal wall function at baseline (pre-operatively) and 6 months postoperatively

Secondary Outcome(s)

There are no secondary outcome measures

Secondary ID(s)

GUMP

Nil known

Source(s) of Monetary Support

Umeå Universitet

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Approved 10/01/2016, Regional Ethics Review Board, Umeå (Samverkanshuset, Umeå University, Umeå, 901 87, Sweden; [phone]; [e-mail]), ref: 2015/367-31 Since this approval, this regional board has been replaced by a national agency, the Swedish Ethical Review Authority

Results

• Date Completed: 31/12/2027