Assessment of Handgrip Strength in Adults With Inflammatory Bowel Disease

NCT02950779 | Unknown DMC

• 1 other identifier: RHM MED1346
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

Inflammatory bowel disease (IBD) is a chronic disease, which causes inflammation of the gut. People with this disease are often poorly nourished. Problems caused by poor nutrition such as poor wound healing can be reduced if it is recognised and treated early. When people with IBD attend outpatients clinic with their IBD specialist they are weighed and their BMI calculated to indicate if they are poorly nourished. Weight and BMI may not always provide a good assessment of how well nourished a person is because it does not describe the amount of muscle in the body in proportion to fat. A person with a low or decreasing amount of muscle but a normal or high BMI is at risk of nutritional problems. Measuring the amount of muscle someone with IBD has in routine practice poses a challenge to clinicians due to time constraints. One-way of measuring the amount of muscle a person has is to measure their muscle strength. This can be measured by recording the strength of a person's handgrip. Handgrip strength can be measured using a hand-held device called a dynamometer. This study aims to test whether it is possible to measure the handgrip strength of people with IBD attending outpatient's clinic. It also aims to test how the measure obtained compares with other methods of assessing whether someone is malnourished and their health. People with a diagnosis of IBD who are aged 18 or older and who are scheduled to attend IBD outpatients clinic in one hospital will be asked to take part in the study. Their handgrip strength will be measured each time they attend clinic over a nine-month period in addition to other information about their health and nutritional state. This study forms part of a Masters in Research being undertaken with The University of Southampton.

Conditions

Inflammatory Bowel Disease; Nutrition

Outcome Measures

Primary Outcomes (1)

• Handgrip strength measurement

  12 months

Secondary Outcomes (5)

• IBD Disease activity

  12 months

• Quality of life Assessment

  12 Months

• Physical Activity Assessment

  12 months

• Malnutrition Screening score

  12 months

• Micronutrient values

  12 months

Interventions

Handgrip Strength Measurement OTHER

Eligibility Criteria

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

Study Population

Adult participants with Inflammatory Bowel Disease attending the Gastroenterology Clinic

You may qualify if:

• Adult participants with a confirmed diagnosis of IBD (≥18 years of age)
• People deemed to have capacity to consent
• People able to understand and read English
• People attending a gastroenterology outpatient clinic appointment

You may not qualify if:

• People physically unable to complete the study procedures
• Any person who is currently participating in another research trial in which the principle investigator is not satisfied to sign a 12-week exemption form.
• People involved in an interventional study.
• People who are currently an inpatient

Sponsors & Collaborators

• University of Southampton: lead
• University Hospital Southampton NHS Foundation Trust: collaborator

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Fraser Cummings, Dr

  University Hospital Southampton NHS Foundation Trust

  STUDY CHAIR

Central Study Contacts

Catherine Foley, Miss

CONTACT

02381206072; catherine.foley@uhs.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 1, 2016
• Study Start: October 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 1, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share