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Thoracic Mobility in Cystic Fibrosis Care

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ClinicalTrials.gov Identifier: NCT04696198
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Göteborg University

Study Description
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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


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: Manual Therapy Intervention Other: Standard care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The patients are randomized to either of the groups, intervention or delayed intervention.
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor will be blinded
Primary Purpose: Treatment
Official Title: Thoracic Mobility in Cystic Fibrosis Care
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Range of motion
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
Manual Therapy Interventions to improve range of motion and decrease pain
Standard care
Standard care
 Other: Standard care
standard care


Outcome Measures
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Primary Outcome Measures :
  1. Manual examination [ Time Frame: Two months after inclusion ]
    Pain and stiffness in the ribcage according to a specific and tested form


Secondary Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04696198


Contacts
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Contact: Monika Fagevik Olsén, PhD +46313421195 monika.fagevik-olsen@vgregion.se
Contact: Niklas Sinderholm Sposato, MSc niklas.sinderholm-sposato@gu.se

Locations
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Sweden
Göteborg University Recruiting
Gothenburg, Sweden, 41345
Contact: Monika Fagevik Olsén, PhD    +46313421195    monika.fagevik-olsen@vgregion.se   
Contact: Niklas Sinderholm Sposato, MSc       niklas.sinderholm-sposato@gu.se   
Sponsors and Collaborators
Göteborg University
Investigators
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Principal Investigator: Monika Fagevik Olsén, PhD Sahlgrenska University Hospital, Sweden
More Information
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT04696198    
Other Study ID Numbers: FoU i VGR: 272 800
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Göteborg University:
Rib cage
Range of motion
Pain
Spirometry
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases