Assessment of Handgrip Strength in Adults With Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02950779
Recruitment Status : Unknown
Verified October 2016 by University of Southampton.
Recruitment status was:  Not yet recruiting
First Posted : November 1, 2016
Last Update Posted : November 1, 2016
University Hospital Southampton NHS Foundation Trust
Information provided by (Responsible Party):
University of Southampton

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
Inflammatory Bowel Disease Nutrition Other: Handgrip Strength Measurement

Study Type : Observational
Estimated 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 : October 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : October 2017

Primary Outcome Measures :
  1. Handgrip strength measurement [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. IBD Disease activity [ Time Frame: 12 months ]
  2. Quality of life Assessment [ Time Frame: 12 Months ]
  3. Physical Activity Assessment [ Time Frame: 12 months ]
  4. Malnutrition Screening score [ Time Frame: 12 months ]
  5. Micronutrient values [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult participants with Inflammatory Bowel Disease attending the Gastroenterology Clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02950779

Contact: Catherine Foley, Miss 02381206072

Sponsors and Collaborators
University of Southampton
University Hospital Southampton NHS Foundation Trust
Study Chair: Fraser Cummings, Dr University Hospital Southampton NHS Foundation Trust

Responsible Party: University of Southampton Identifier: NCT02950779     History of Changes
Other Study ID Numbers: RHM MED1346
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases