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

Primary Purpose

Cystic Fibrosis

Status

Terminated

Phase

Locations

Belgium

Study Type

Observational

Intervention

Rehabilitation

About this trial

This is an observational trial for Cystic Fibrosis focused on measuring body composition, rehabilitation

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zeepreventorium de Haan

Arms of the Study

Arm 1

Arm Type

Arm Label

rehabilitation

Arm Description

All included patients get an pre-intervention and a post intervention analysis

Outcomes

Primary Outcome Measures

body composition change

Dual energy X-ray absorptiometry measured Fat mass index (kg/m*2)

body composition change

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

Body mass index change

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

Weight change

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

pulmonary function change

forced expiratory volume in 1 second (% of normal)

pulmonary function change

Forced Vital capacity (% of normal)

Secondary Outcome Measures

Physical activity

"SenseWear pro 3" armband measured physical activity

dietary intake

macronutrient intake measured based on 2 days/week weighed nutritional intake

Full Information

NCT ID

NCT04527796

First Posted

August 19, 2020

Last Updated

December 15, 2022

Sponsor

University Hospital, Ghent

1. Study Identification

Unique Protocol Identification Number

NCT04527796

Brief Title

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

Official Title

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

Study Type

Observational

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Terminated

Why Stopped

number included

Study Start Date

September 1, 2018 (Actual)

Primary Completion Date

May 1, 2020 (Actual)

Study Completion Date

July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

body composition, rehabilitation

7. Study Design

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rehabilitation

Arm Description

All included patients get an pre-intervention and a post intervention analysis

Intervention Type

Other

Intervention Name(s)

Rehabilitation

Intervention Description

During the rehabilitation program a multidisciplinary team, consisting of a pneumologist, dietician, psychologist, social worker and several physiotherapists, coach the cystic fibrosis patients. The physiotherapists help with autogenic drainage and aerosol therapy (2-3 times/day) and supervise physical activity (5, 1-hour lasting, training sessions/week: swimming 2, Fitness training 2, 1 session of choice). The dietician calculates basal and theoretical energy needs . A carbohydrate-rich snack before exercise, to improve exercise tolerance and a carbohydrate-protein-rich snack afterwards to improve recuperation is provided.

Primary Outcome Measure Information:

Title

body composition change

Description

Dual energy X-ray absorptiometry measured Fat mass index (kg/m*2)

Time Frame