Clinical trial NCT02950779: Assessment of Handgrip Strength in Adults With Inflammatory Bowel Disease
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Disease
Nutrition
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: University Hospital Southampton NHS Foundation Trust
First posted: 2016-11-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult participants with Inflammatory Bowel Disease attending the Gastroenterology Clinic

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.


Eligibility criteria: 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

Primary outcomes:
measure: Handgrip strength measurement
timeFrame: 12 months
Secondary outcomes:
measure: IBD Disease activity
timeFrame: 12 months
measure: Quality of life Assessment
timeFrame: 12 Months
measure: Physical Activity Assessment
timeFrame: 12 months
measure: Malnutrition Screening score
timeFrame: 12 months
measure: Micronutrient values
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Fraser Cummings, Dr
role: STUDY_CHAIR
References: