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Thoracic Mobility in Cystic Fibrosis Care

Primary Purpose

Cystic Fibrosis

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Manual Therapy Intervention
Standard care
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Rib cage, Range of motion, Pain, Spirometry

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Göteborg UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Range of motion

Standard care

Arm Description

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

Standard care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Vital capacity
Spirometry
Forced vital capacity during one second
Spirometry
Respiratory Muscle Strength
Maximum inspiratory and expiratory pressure
Respiratory movements
By Respiratory Movement Measuring Instrument
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).

Full Information

First Posted
January 4, 2021
Last Updated
September 29, 2023
Sponsor
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT04696198
Brief Title
Thoracic Mobility in Cystic Fibrosis Care
Official Title
Thoracic Mobility in Cystic Fibrosis Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Rib cage, Range of motion, Pain, Spirometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients are randomized to either of the groups, intervention or delayed intervention.
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be blinded
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Range of motion
Arm Type
Experimental
Arm Description
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
Arm Title
Standard care
Arm Type
Other
Arm Description
Standard care
Intervention Type
Other
Intervention Name(s)
Manual Therapy Intervention
Intervention Description
Manual Therapy Interventions to improve range of motion and decrease pain
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
standard care
Primary Outcome Measure Information:
Title
Manual examination
Description
Pain and stiffness in the ribcage according to a specific and tested form
Time Frame
Two months after inclusion
Secondary Outcome Measure Information:
Title
Vital capacity
Description
Spirometry
Time Frame
Two months after inclusion
Title
Forced vital capacity during one second
Description
Spirometry
Time Frame
Two months after inclusion
Title
Respiratory Muscle Strength
Description
Maximum inspiratory and expiratory pressure
Time Frame
Two months after inclusion
Title
Respiratory movements
Description
By Respiratory Movement Measuring Instrument
Time Frame
Two months after inclusion
Title
Patient Specific Functional Scale, PSFS
Description
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).
Time Frame
Two months after inclusion

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monika Fagevik Olsén, PhD
Phone
+46313421195
Email
monika.fagevik-olsen@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Niklas Sinderholm Sposato, MSc
Email
niklas.sinderholm-sposato@gu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monika Fagevik Olsén, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Göteborg University
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Fagevik Olsén, PhD
Phone
+46313421195
Email
monika.fagevik-olsen@vgregion.se
First Name & Middle Initial & Last Name & Degree
Niklas Sinderholm Sposato, MSc
Email
niklas.sinderholm-sposato@gu.se

12. IPD Sharing Statement

Plan to Share IPD
No

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Thoracic Mobility in Cystic Fibrosis Care

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