Thoracic Mobility in Cystic Fibrosis Care
- Conditions
- Cystic Fibrosis
- Interventions
- Other: Manual Therapy InterventionOther: Standard care
- Registration Number
- NCT04696198
- Lead Sponsor
- Göteborg University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- Diagnosed with cystic fibrosis
- >18 years of age
- participation in clinical trials or other interventional studies, or, medical conditions that -as judged by the medical doctor in charge contraindicates the proposed intervention.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Range of motion Manual Therapy Intervention 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 Standard care Standard care Standard care
- Primary Outcome Measures
Name Time Method Manual examination Two months after inclusion Pain and stiffness in the ribcage according to a specific and tested form
- Secondary Outcome Measures
Name Time Method Forced vital capacity during one second Two months after inclusion Spirometry
Patient Specific Functional Scale, PSFS Two months after inclusion 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).
Vital capacity Two months after inclusion Spirometry
Respiratory movements Two months after inclusion By Respiratory Movement Measuring Instrument
Respiratory Muscle Strength Two months after inclusion Maximum inspiratory and expiratory pressure
Trial Locations
- Locations (1)
Göteborg University
🇸🇪Gothenburg, Sweden