The purpose of this study was to evaluate the impact of pulmonary rehabilitation on the general health of patients with CF that are already in treatment with CF transmembrane conductance regulator (CFTR) modulators
Design
An interventional study of 28 patients who performed pulmonary rehabilitation for 3 weeks
Settings and conduct
The study was performed at a single pulmonary rehabilitation center in Timisoara, Romania. Patients received for 3 weeks pulmonary rehabilitation
Participants/Inclusion and exclusion criteria
Inclusion criteria were patients confirmed with CF after medical consultation, age > 18 years, sweat test (iontophoresis), genetic testing, and non-smokers. Furthermore, it was imperative to ascertain the current therapy status involving CFTR modulators. Exclusion criteria were: age < 18 years, exacerbations in the last month, patients with active smoking status, and other lung diseases than CF.
Intervention groups
The intervention group received for 21 days, daily training sessions that lasted between 30 and 40 minutes and included diaphragmatic breathing, pursed-lip breathing, strength and endurance training for both the upper and lower extremities, respiratory muscle training, and clearance techniques
Main outcome variables
The quality of life assessed with the CFQ-R questionnaire improved significantly.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231115060065N2
Registration date:2023-12-05, 1402/09/14
Registration timing:retrospective
Last update:2023-12-05, 1402/09/14
Update count:0
Registration date
2023-12-05, 1402/09/14
Registrant information
Name
Alexandru Florian Crișan
Name of organization / entity
University of Medicine and Pharmacy Victor Babes Timisoara
Country
Romania
Phone
+40 765 525 688
Email address
crisan@umft.ro
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-30, 1402/03/09
Expected recruitment end date
2023-11-12, 1402/08/21
Actual recruitment start date
2023-06-02, 1402/03/12
Actual recruitment end date
2023-11-12, 1402/08/21
Trial completion date
2023-11-12, 1402/08/21
Scientific title
Effects of pulmonary rehabilitation in adult patients with cystic fibrosis - a clinical intervention
Public title
Pulmonary rehabilitation in patients with cystic fibrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients confirmed with cystic fibrosis after medical consultation
Age > 18 years
Non-smokers status
Exclusion criteria:
Age < 18 years
Exacerbations in the last month
Other lung diseases than cystic fibrosis
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
28
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Comisia de Etică a Spitalului de Boli Infectioase si Pneumoftiziologie Victor Babes Timisoara
Street address
Gheorghe Adam nr. 13
City
Timisoara
Postal code
300310
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
4989
Health conditions studied
1
Description of health condition studied
Cystic fibrosis
ICD-10 code
E84
ICD-10 code description
Cystic fibrosis
Primary outcomes
1
Description
CFQ-R questionnaire domains will improve
Timepoint
Before intervention and 3 weeks after intervention.
Method of measurement
CFQ-R.
Secondary outcomes
1
Description
Physical capacity will improve
Timepoint
before intervention and 3 weeks after intervention
Method of measurement
6MWT
2
Description
Respiratory muscle strength will improve
Timepoint
before intervention and 3 weeks after intervention
Method of measurement
MIP/MEP
Intervention groups
1
Description
Intervention group: received for 21 days, daily training sessions that lasted between 30 and 40 minutes and included diaphragmatic breathing, pursed-lip breathing, strength and endurance training for both the upper and lower extremities, respiratory muscle training, and clearance techniques
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinical Hospital of Infectious Diseases and Pulmonology, Victor Babes Timisoara, Romania
Full name of responsible person
Pescaru Camelia Corina
Street address
Gheorghe Adam nr. 13
City
Timisoara
Postal code
300310
Phone
+40 722 818 228
Email
pescaru.camelia@umft.ro
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Medicine and Pharmacy Victor Babes Timisoara
Full name of responsible person
Pescaru Camelia Corina
Street address
Eftimie Murgu
City
Timisoara
Postal code
300041
Phone
+40 722 818 228
Email
pescaru.camelia@umft.ro
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Medicine and Pharmacy Victor Babes Timisoara
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Medicine and Pharmacy Victor Babes Timisoara
Full name of responsible person
Pesacaru Camelia Corina
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Eftimie Murgu
City
Timisoara
Province
Timis
Postal code
300041
Phone
+40 722 818 228
Email
pescaru.camelia@umft.ro
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Medicine and Pharmacy Victor Babes Timisoara
Full name of responsible person
Pescaru Camelia Corina
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Pneumology
Street address
Eftimie Murgu
City
Timisoara
Province
Timis
Postal code
300041
Phone
+40 722 818 228
Email
pescaru.camelia@umft.ro
Person responsible for updating data
Contact
Name of organization / entity
University of Medicine and Pharmacy Victor Babes Timisoara
Full name of responsible person
Pescaru Camelia Corina
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Pneumology
Street address
Eftimie Murgu
City
Timisoara
Province
Timis
Postal code
300041
Phone
+40 722 818 228
Email
pescaru.camelia@umft.ro
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD