Assessment of Handgrip Strength in Adults With Inflammatory Bowel Disease

Inflammatory Bowel Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02950779
• Other study ID #: RHM MED1346
• Status: Not yet recruiting
• Phase: N/A
• First received: October 28, 2016
• Last updated: October 31, 2016
• Start date: October 2016
• Est. completion date: October 2017

Study information

• Verified date: October 2016
• Source: University of Southampton
• Contact: Catherine Foley, Miss
• Phone: 02381206072
• Email: catherine.foley[@]uhs.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Nutrition

Intervention

Other:
• Handgrip Strength Measurement

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Southampton	University Hospital Southampton NHS Foundation Trust.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Handgrip strength measurement		12 months	No
Secondary	IBD Disease activity		12 months	No
Secondary	Quality of life Assessment		12 Months	No
Secondary	Physical Activity Assessment		12 months	No
Secondary	Malnutrition Screening score		12 months	No
Secondary	Micronutrient values		12 months	No