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

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: Manual Therapy Intervention; Other: Standard care

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 41345
    • Göteborg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard care	Other: Standard care; standard care
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Manual examination	Pain and stiffness in the ribcage according to a specific and tested form	Two months after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital capacity	Spirometry	Two months after inclusion
Forced vital capacity during one second	Spirometry	Two months after inclusion
Respiratory Muscle Strength	Maximum inspiratory and expiratory pressure	Two months after inclusion
Respiratory movements	By Respiratory Movement Measuring Instrument	Two months after inclusion
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

Collaborators and Investigators

• Sponsor: Göteborg University
• Investigators: Principal Investigator: Monika Fagevik Olsén, PhD, Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Spirometry; Range of motion; Rib cage
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: FoU i VGR: 272 800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No