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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: Rehabilitation

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 Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Belgium
  • De Haan, Belgium, 8420
    • Zeepreventorium de Haan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients With Cystic Fibrosis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Other: Rehabilitation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body composition change	Dual energy X-ray absorptiometry measured Fat mass index (kg/m*2)	day 0 and day 21 (start and end of the rehabilitation program)
body composition change	Dual energy X-ray absorptiometry measured fat free mass (kg/m*2)	day 0 and day 21 (start and end of the rehabilitation program)
Body mass index change	calculated based on weight and height (kg/m*2) converted in standard deviations	day 0 and day 21 (start and end of the rehabilitation program)
Weight change	Scale weighed weight (kg) converted in standard deviations of normal population of normal populations	day 0 and day 21 (start and end of the rehabilitation program)
pulmonary function change	forced expiratory volume in 1 second (% of normal)	day 0 and day 21 (start and end of the rehabilitation program)
pulmonary function change	Forced Vital capacity (% of normal)	day 0 and day 21 (start and end of the rehabilitation program)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Stephanie Van Biervliet, MD, PhD, Gent University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Estimate): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: rehabilitation; body composition
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: B670201939582

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No