Assessment of Handgrip Strength in Adults With Inflammatory Bowel Disease

Sponsor
University of Southampton (Other)
Overall Status
Unknown status
CT.gov ID
NCT02950779
Collaborator
University Hospital Southampton NHS Foundation Trust (Other)
25
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Handgrip Strength Measurement

Study Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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 Start Date :
Oct 1, 2016
Anticipated Primary Completion Date :
Aug 1, 2017
Anticipated Study Completion Date :
Oct 1, 2017

Outcome Measures

Primary Outcome Measures

  1. Handgrip strength measurement [12 months]

Secondary Outcome Measures

  1. IBD Disease activity [12 months]

  2. Quality of life Assessment [12 Months]

  3. Physical Activity Assessment [12 months]

  4. Malnutrition Screening score [12 months]

  5. Micronutrient values [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Southampton
  • University Hospital Southampton NHS Foundation Trust

Investigators

  • Study Chair: Fraser Cummings, Dr, University Hospital Southampton NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Southampton
ClinicalTrials.gov Identifier:
NCT02950779
Other Study ID Numbers:
  • RHM MED1346
First Posted:
Nov 1, 2016
Last Update Posted:
Nov 1, 2016
Last Verified:
Oct 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2016