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Thoracic Mobility in Cystic Fibrosis Care

Thoracic Mobility in Cystic Fibrosis Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04696198
Enrollment
63
Registered
2021-01-06
Start date
2019-09-09
Completion date
2023-10-31
Last updated
2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Rib cage, Range of motion, Pain, Spirometry

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

Interventions

OTHERManual Therapy Intervention

Manual Therapy Interventions to improve range of motion and decrease pain

OTHERStandard care

standard care

Sponsors

Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcome assessor will be blinded

Intervention model description

The patients are randomized to either of the groups, intervention or delayed intervention.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Manual examinationTwo months after inclusionPain and stiffness in the ribcage according to a specific and tested form

Secondary

MeasureTime frameDescription
Vital capacityTwo months after inclusionSpirometry
Forced vital capacity during one secondTwo months after inclusionSpirometry
Respiratory Muscle StrengthTwo months after inclusionMaximum inspiratory and expiratory pressure
Respiratory movementsTwo months after inclusionBy Respiratory Movement Measuring Instrument
Patient Specific Functional Scale, PSFSTwo months after inclusionFunction 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).

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026