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OpenTrials
Completed

NCT Number: NCT04696198

Thoracic Mobility in Cystic Fibrosis Care

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

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Neurologic Manifestations Pain Pancreatic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Göteborg University

Gothenburg, 41345, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual Therapy Intervention

Other

Manual Therapy Interventions to improve range of motion and decrease pain

Standard care

Other

standard care

Primary outcomes

  1. Manual examination

    Time frame: Two months after inclusion

    Pain and stiffness in the ribcage according to a specific and tested form

Secondary outcomes

  1. Vital capacity

    Time frame: Two months after inclusion

    Spirometry

  2. Forced vital capacity during one second

    Time frame: Two months after inclusion

    Spirometry

  3. Respiratory Muscle Strength

    Time frame: Two months after inclusion

    Maximum inspiratory and expiratory pressure

  4. Respiratory movements

    Time frame: Two months after inclusion

    By Respiratory Movement Measuring Instrument

  5. Patient Specific Functional Scale, PSFS

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2021
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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