Thoracic Mobility in Cystic Fibrosis Care

NCT04696198 | Completed

• 1 other identifier: FoU i VGR: 272 800
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Conditions

Cystic Fibrosis

Keywords

Rib cage; Range of motion; Pain; Spirometry

Outcome Measures

Primary Outcomes (1)

• Manual examination

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

  Two months after inclusion

Secondary Outcomes (5)

• Vital capacity

  Two months after inclusion

• Forced vital capacity during one second

  Two months after inclusion

• Respiratory Muscle Strength

  Two months after inclusion

• Respiratory movements

  Two months after inclusion

• Patient Specific Functional Scale, PSFS

  Two months after inclusion

Study Arms (2)

Range of motion

EXPERIMENTAL

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

Standard care

OTHER

Standard care

Other: Standard care

Interventions

Manual Therapy Intervention OTHER

Manual Therapy Interventions to improve range of motion and decrease pain

Range of motion

Standard care OTHER

standard care

Standard care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with cystic fibrosis
• \>18 years of age

You may not qualify if:

• participation in clinical trials or other interventional studies, or, medical conditions that -as judged by the medical doctor in charge contraindicates the proposed intervention.

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Göteborg University

Gothenburg, 41345, Sweden

Location

Related Publications (1)

• Sinderholm Sposato N, Bjersa K, Gilljam M, Lannefors L, Fagevik Olsen M. Effectiveness of manual therapy interventions in cystic fibrosis care: a pilot study. J Bodyw Mov Ther. 2024 Jul;39:323-329. doi: 10.1016/j.jbmt.2024.02.036. Epub 2024 Mar 12.

  PMID: 38876647 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis; Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Monika Fagevik Olsén, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: September 9, 2019
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)