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

NCT04527796 | Terminated

• 1 other identifier: B670201939582
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

body composition; rehabilitation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Physical activity

  Week 1

• dietary intake

  2 days/week for 3 consecutive weeks

Study Arms (1)

rehabilitation

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

Other: Rehabilitation

Interventions

Rehabilitation OTHER

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.

rehabilitation

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients With Cystic Fibrosis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Zeepreventorium de Haan

De Haan, 8420, Belgium

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Stephanie Van Biervliet, MD, PhD

  Gent university hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 27, 2020
• Study Start: September 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: July 1, 2020
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)