Cystic FibrosisNCT04527796
Influence of a Residential Rehabilitation Program on Body Composition in Patients with Cystic Fibrosis
An observational study of Cystic Fibrosis, run by University Hospital, Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Rehabilitation
- How many people
- 39 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2018to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients With Cystic Fibrosis
Who may be able to join
- Cystic fibrosis
- stay at the rehabilitation center for at least 3 consecutive weeks
Who cannot join
- steroid use
- absence from the program for more than 2 consecutive days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Rehabilitation
- Keywords
- body composition, rehabilitation
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| rehabilitation | All included patients get an pre-intervention and a post intervention analysis Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
body composition change
Dual energy X-ray absorptiometry measured Fat mass index (kg/m*2)
Measured: 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)
Measured: 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
Measured: 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
Measured: day 0 and day 21 (start and end of the rehabilitation program)
pulmonary function change
forced expiratory volume in 1 second (% of normal)
Measured: day 0 and day 21 (start and end of the rehabilitation program)
pulmonary function change
Forced Vital capacity (% of normal)
Measured: day 0 and day 21 (start and end of the rehabilitation program)
Secondary outcomes (2)
Physical activity
"SenseWear pro 3" armband measured physical activity
Measured: Week 1
dietary intake
macronutrient intake measured based on 2 days/week weighed nutritional intake
Measured: 2 days/week for 3 consecutive weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Sep 2018
- Primary completion1 May 2020
- Study completion1 Jul 2020
Why it stopped: number included
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Van Biervliet, MD, PhD, Principal investigator, Gent university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527796
- Sponsor's protocol ID
- B670201939582
- Status last verified
- Sep 2024
- First submitted
- 19 Aug 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Residential Rehabilitation Program on Body Composition in Patients with Cystic Fibrosis (children and Adults)
- ClinicalTrials.gov ID
- NCT04527796
- Acronym / sponsor ID
- B670201939582
- Conditions
- Cystic Fibrosis
- Keywords
- body composition, rehabilitation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: number included
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rehabilitation | – | Other: RehabilitationAll included patients get an pre-intervention and a post intervention analysis |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients With Cystic Fibrosis
Key inclusion criteria (2 listed)
- Cystic fibrosis
- stay at the rehabilitation center for at least 3 consecutive weeks
Key exclusion criteria (2 listed)
- steroid use
- absence from the program for more than 2 consecutive days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationDuring 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. | Other | rehabilitation |
Primary outcome
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)
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)
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
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
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)
pulmonary function change
Time frame: day 0 and day 21 (start and end of the rehabilitation program)
Forced Vital capacity (% of normal)
2 secondary outcomes
Physical activity
Time frame: Week 1
dietary intake
Time frame: 2 days/week for 3 consecutive weeks
Results and safety
The study was stopped early (reason given: number included). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Van Biervliet, MD, PhD principal investigator
Gent university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: number included). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body composition change (time frame: day 0 and day 21 (start and end of the rehabilitation program)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.