Thoracic Mobility in Cystic Fibrosis Care

Study Overview
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Brief Summary
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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

Official Title
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Thoracic Mobility in Cystic Fibrosis Care

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Other: Manual Therapy Intervention
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients are randomized to either of the groups, intervention or delayed intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Range of motion<br>Treatment is based on a set diagnostic and therapeutic protocol and carried out by registered health care professionals that are additionally trained in manual therapy intervention. 30 minutes of treatment will be given once a week over a period of two months | Other: Manual Therapy Intervention<br>* Manual Therapy Interventions to improve range of motion and decrease pain<br>|
| Other: Standard care<br>Standard care | Other: Standard care<br>* standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manual examination | Pain and stiffness in the ribcage according to a specific and tested form | Two months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital capacity | Spirometry | Two months after inclusion | 
| Forced vital capacity during one second | Spirometry | Two months after inclusion | 
| Respiratory Muscle Strength | Maximum inspiratory and expiratory pressure | Two months after inclusion | 
| Respiratory movements | By Respiratory Movement Measuring Instrument | Two months after inclusion | 
| Patient Specific Functional Scale, PSFS | Function during individual activities. Ability to perform the individual activities are scored on a scale from 0 (not able to perform) to 10 (totally able to perform). | Two months after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rib cage, Range of motion, Pain, Spirometry