Influence of a Residential Rehabilitation Program on Body Composition in Patients With Cystic Fibrosis

Terminated

• Conditions: Cystic Fibrosis
• Interventions: Other: Rehabilitation

• Registration Number: NCT04527796
• Lead Sponsor: University Hospital, Ghent

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.

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2020-05-01
• Study Completion: 2020-07-01
• Status Verified: 2020-08
• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-27
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
rehabilitation	Rehabilitation	All included patients get an pre-intervention and a post intervention analysis

Primary Outcome Measures

Name	Time	Method
Weight change	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	day 0 and day 21 (start and end of the rehabilitation program)	Forced Vital capacity (% of normal)
body composition change	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	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 Outcome Measures

Name	Time	Method
Physical activity	Week 1	"SenseWear pro 3" armband measured physical activity
dietary intake	2 days/week for 3 consecutive weeks	macronutrient intake measured based on 2 days/week weighed nutritional intake

Trial Locations

Locations (1)

Zeepreventorium de Haan; 🇧🇪 De Haan, Belgium