Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04655547
Other study ID # MS19953
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 8, 2021
Est. completion date December 9, 2021

Study information

Verified date August 2021
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An intervention study on the effect of dietary guidance with focus on implementing recommended food texture, at the department of Eating and Swallowing difficulties, Region Midtjylland, Denmark. Energy- and protein intake, Weightloss, Bodymass composition, Fluid balance and Activities of Daily Living (ADL), will be measured by Bioimpedance spectroscopy, interviews and a questionnaire.


Description:

It is know that people with eating- and swallowing difficulties(known as dysphagia), is prone to weightloss due to insufficient energy- and protein intake, and a reduction in ADL. ADL will in this project have its focus on the eating situation. The projects research questions are: - Will dietary guidance with texture implementation increase energy intake in patients being examined on an outpatient basis for dysphagia, based on the Fiberoptic Endoscopic Evaluation of Swallowing (FEES) recommendation? - Can a dietetic guidance with texture implementation increase quality of life and ADL in patients with dysphagia? Recruitment and data collection will take place at Hammel Neurocenter, DK. Each patient will be included for eight weeks, after their first FEES examination. The participants will be randomized to control or intervention, and strata into three groups based on Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) 1, 2-3 and 4. Within the eight weeks, participants have to show up three times to measurements, interviews and questionnaire, in addition to this, the intervention groups will have three follow-up phone meetings.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date December 9, 2021
Est. primary completion date October 17, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Signed consent form - Newly refered patients to FEES examination - Score 1-4 on FEDSS-scale - Consumes 50% energy or more orally - Consumes less energy than calculated energy need (Harris-Benedict) - Individuals of full legal capacity - Individuals above 18 of years - That the patient is capable of executing examinations Exclusion Criteria: - Individuals with known eating disorders - Ineligible individuals - Individual in need of translator - Individuals participating in another trial

Study Design


Intervention

Other:
Dietary guidance
Dietary guidance with focus on texture and energy intake, preformed by certified dietitians.

Locations

Country Name City State
Denmark Hammel Neurorehabilitation Centre and University Research Clinic Hammel Midtjylland

Sponsors (2)

Lead Sponsor Collaborator
University of Aarhus University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in energy intake, from baseline. Change in energy intake, measured from baseline. Measured in kilojoule by a standardized interview with examples of pictures to determine serving size. Eight weeks
Secondary Changes in Dysphagia Handicap Index (DHI) total and section (E and F) score. DHI is a questionnaire with 25 questions, divided into three sections. possible scores are minimum 25 and maximum 125. The higher the score, the worse dysphagia status.
Measured in points, changes from baseline.
Eight weeks
Secondary In how many questions in the DHI, does the intervention group change the score in relation to the control group, and with how much. Measured in points, changes from baseline. Eight weeks
Secondary Body Weight. Measured in kilograms, by bioimpedance spectroscopy, changes from baseline. Eight weeks
Secondary Lean Body Mass. Measured in kilograms, by bioimpedance spectroscopy, changes from baseline. Eight weeks
Secondary Fat Mass. Measured in kilograms, by bioimpedance spectroscopy, changes from baseline. Eight weeks
Secondary Fluid Balance. Measured in kilograms, by bioimpedance spectroscopy, changes from baseline. Eight weeks
Secondary Changes in protein intake. Measured in gram, by a standardized interview with examples of pictures to determine serving size, from baseline. Eight weeks
Secondary Compliance of recommended changes. Measured by score through interview. Minimum score 1 and maximum score 5. The greater the score, the better compliance. Eight weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT06238557 - Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT05472935 - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers N/A
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04281953 - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Recruiting NCT05546931 - Mobile Health Program for Rural Hypertension N/A
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Recruiting NCT04142827 - The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX) N/A
Active, not recruiting NCT05903638 - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT03813420 - Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level N/A
Recruiting NCT05550545 - Infant RSV Infections and Health-related Quality of Life of Families
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Recruiting NCT05233020 - Robotic Versus Hybrid Assisted Ventral Hernia Repair N/A
Terminated NCT03304184 - The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life Phase 3
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Recruiting NCT05380856 - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction N/A