Assessment of Handgrip Strength in Adults With Inflammatory Bowel Disease

An Investigation Into Handgrip Strength as a Dietetic Assessment Tool to Detect Changes in the Nutritional and Health Status of Adults With Inflammatory Bowel Disease: A Longitudinal Observational Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Disease; Nutrition
• Intervention / Treatment: Other: Handgrip Strength Measurement

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult participants with Inflammatory Bowel Disease attending the Gastroenterology Clinic

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. People physically unable to complete the study procedures
2. 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.
3. People involved in an interventional study.
4. People who are currently an inpatient

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Handgrip strength measurement	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Southampton
• Collaborators: University Hospital Southampton NHS Foundation Trust
• Investigators: Study Chair: Fraser Cummings, Dr, University Hospital Southampton NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: October 28, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Estimate): November 1, 2016
• Last Update Submitted That Met QC Criteria: October 31, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: RHM MED1346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No