Thoracic Mobility in Cystic Fibrosis Care

Cystic Fibrosis Clinical Trial

Official title:

Thoracic Mobility in Cystic Fibrosis Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04696198
• Other study ID #: FoU i VGR: 272 800
• Status: Completed
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2024
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Manual Therapy Intervention
Manual Therapy Interventions to improve range of motion and decrease pain
• Standard care
standard care

Locations

Country	Name	City	State
Sweden	Göteborg University	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Manual examination	Pain and stiffness in the ribcage according to a specific and tested form	Two months after inclusion
Secondary	Vital capacity	Spirometry	Two months after inclusion
Secondary	Forced vital capacity during one second	Spirometry	Two months after inclusion
Secondary	Respiratory Muscle Strength	Maximum inspiratory and expiratory pressure	Two months after inclusion
Secondary	Respiratory movements	By Respiratory Movement Measuring Instrument	Two months after inclusion
Secondary	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