Clinical trial NCT04696198: Thoracic Mobility in Cystic Fibrosis Care
Official title: Thoracic Mobility in Cystic Fibrosis Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Rib cage
Range of motion
Pain
Spirometry
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 63
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients are randomized to either of the groups, intervention or delayed intervention.
Primary purpose: TREATMENT

Brief summary: Cystic fibrosis (CF) is an inherited, genetic disease of the body's mucus-producing glands that primarily affects the lungs and gastrointestinal tract. There are no studies that have examined anatomical changes, the connection between structure and function in the ribcage and the effect of symptom-relieving manual treatment.

The purpose of the study is therefore to investigate chest mobility in people with CF.

Method The study is conducted in three parts; a / A retrospective longitudinal part whose purpose is to investigate possible changes in the chest configuration in relation to deterioration of lung volumes in a cohort of CF patients. Chest configuration will be measured standardized and blinded on computed tomography (CT) images and related to results from spirometry examinations.

b / A prospective, consecutive cross-sectional study of the same cohort. The aim is to investigate the extent of stiffness and pain that is examined standardized (number of pain-free / normal moving structures) and its relation to objective examination of respiratory movements, respiratory muscle strength and spirometry.

c / A randomized controlled single-blind study aimed at evaluating the effect of manual treatment for pain and reduced mobility in patients with these symptoms. The treatments consist of standardized manual therapy with passive joint mobilization without impulse and soft tissue treatment. Evaluation will be done via the examination protocol in sub-study b / as well as objective measurements of respiratory movements (primary variable), respiratory muscle strength and spirometry which will be performed by a blinded tester both before and immediately after the intervention / control period.

Clinical significance When it comes to CF care, great medical advances have been made and for Swedish patients, the physiotherapeutic active treatment has proven to have very good effects. However, there are areas where care can be improved. The results from our study will provide additional breadth to strategies in CF care


Eligibility criteria: Inclusion Criteria:

* Diagnosed with cystic fibrosis
* \>18 years of age

Exclusion Criteria:

* participation in clinical trials or other interventional studies, or, medical conditions that -as judged by the medical doctor in charge contraindicates the proposed intervention.

Primary outcomes:
measure: Manual examination
timeFrame: Two months after inclusion
Secondary outcomes:
measure: Vital capacity
timeFrame: Two months after inclusion
measure: Forced vital capacity during one second
timeFrame: Two months after inclusion
measure: Respiratory Muscle Strength
timeFrame: Two months after inclusion
measure: Respiratory movements
timeFrame: Two months after inclusion
measure: Patient Specific Functional Scale, PSFS
timeFrame: Two months after inclusion
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Göteborg University
Study officials:
affiliation: Sahlgrenska University Hospital
name: Monika Fagevik Olsén, PhD
role: PRINCIPAL_INVESTIGATOR
References: