Skip to main content
Clinical Trials/NCT04527796
NCT04527796
Terminated
Not Applicable

Influence of a Residential Rehabilitation Program on Body Composition in Patients With Cystic Fibrosis (Children and Adults)

University Hospital, Ghent1 site in 1 country39 target enrollmentSeptember 1, 2018
ConditionsCystic Fibrosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cystic Fibrosis
Sponsor
University Hospital, Ghent
Enrollment
39
Locations
1
Primary Endpoint
Weight change
Status
Terminated
Last Updated
3 years ago

Overview

Brief Summary

The aim is to evaluate the impact of a 3-week lasting residential rehabilitation program for patients with cystic fibrosis on their nutritional status measured as BMI and body composition and pulmonary function.

Detailed Description

Cystic fibrosis Patients following a residential rehabilitation program consisting of dietary adaptation, physical therapy for airway drainage and supervised inhalation therapy and physical activity for at least 3 weeks are asked to participate. Weight, height, body composition and pulmonary function will be measured at start and end of the program. Dietary intake during the program is calculated based on a 2 day weighed intake diary and physical activity will be measured with the "SenseWear pro 3" armband.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
July 1, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Cystic fibrosis
  • stay at the rehabilitation center for at least 3 consecutive weeks

Exclusion Criteria

  • steroid use
  • absence from the program for more than 2 consecutive days

Outcomes

Primary Outcomes

Weight change

Time Frame: day 0 and day 21 (start and end of the rehabilitation program)

Scale weighed weight (kg) converted in standard deviations of normal population of normal populations

pulmonary function change

Time Frame: day 0 and day 21 (start and end of the rehabilitation program)

Forced Vital capacity (% of normal)

body composition change

Time Frame: day 0 and day 21 (start and end of the rehabilitation program)

Dual energy X-ray absorptiometry measured fat free mass (kg/m\*2)

Body mass index change

Time Frame: day 0 and day 21 (start and end of the rehabilitation program)

calculated based on weight and height (kg/m\*2) converted in standard deviations

Secondary Outcomes

  • Physical activity(Week 1)
  • dietary intake(2 days/week for 3 consecutive weeks)

Study Sites (1)

Loading locations...

Similar Trials