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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04527796
• Other study ID #: B670201939582
• Status: Terminated
• Start date: September 1, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2020
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: July 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.

Locations

Country	Name	City	State
Belgium	Zeepreventorium de Haan	De Haan

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	pulmonary function change	forced expiratory volume in 1 second (% of normal)	day 0 and day 21 (start and end of the rehabilitation program)
Primary	pulmonary function change	Forced Vital capacity (% of normal)	day 0 and day 21 (start and end of the rehabilitation program)
Secondary	Physical activity	"SenseWear pro 3" armband measured physical activity	Week 1
Secondary	dietary intake	macronutrient intake measured based on 2 days/week weighed nutritional intake	2 days/week for 3 consecutive weeks