Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04527796
Recruitment Status : Terminated (number included)
First Posted : August 27, 2020
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: Rehabilitation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The study is a pre- postintervention analysis with evaluation at start and end of the rehabilitation intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of a Residential Rehabilitation Program on Body Composition in Patients With Cystic Fibrosis (Children and Adults)
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm 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.





Primary Outcome Measures :
  1. body composition change [ Time Frame: day 0 and day 21 (start and end of the rehabilitation program) ]
    Dual energy X-ray absorptiometry measured Fat mass index (kg/m*2)

  2. body composition change [ Time Frame: day 0 and day 21 (start and end of the rehabilitation program) ]
    Dual energy X-ray absorptiometry measured fat free mass (kg/m*2)

  3. Body mass index change [ Time Frame: 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

  4. Weight change [ Time Frame: 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

  5. pulmonary function change [ Time Frame: day 0 and day 21 (start and end of the rehabilitation program) ]
    forced expiratory volume in 1 second (% of normal)

  6. pulmonary function change [ Time Frame: day 0 and day 21 (start and end of the rehabilitation program) ]
    Forced Vital capacity (% of normal)


Secondary Outcome Measures :
  1. Physical activity [ Time Frame: Week 1 ]
    "SenseWear pro 3" armband measured physical activity

  2. dietary intake [ Time Frame: 2 days/week for 3 consecutive weeks ]
    macronutrient intake measured based on 2 days/week weighed nutritional intake



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04527796


Locations
Layout table for location information
Belgium
Zeepreventorium de Haan
De Haan, Belgium, 8420
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Layout table for investigator information
Principal Investigator: Stephanie Van Biervliet, MD, PhD Gent university hospital
Layout table for additonal information
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT04527796    
Other Study ID Numbers: B670201939582
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Ghent:
body composition
rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases