NCT04170114

Brief Summary

The effect of comprehensive respiratory physiotherapy applications on respiratory function, functional capacity and peripheral muscle strength in children with cystic fibrosis and non-cystic fibrosis will be compared.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

10 months

First QC Date

November 12, 2019

Last Update Submit

November 1, 2020

Conditions

Cystic FibrosisBronchiectasis

Keywords

Cystic FibrosisBronchiectasisRespiratory PhysiotherapyPulmonary FunctionExercise CapacitySix Minute Walk TestMuscle Strength

Outcome Measures

Primary Outcomes (7)

  • Forced Vital Capacity (FVC)

    FVC will be measured using basic spirometry and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)

    8 Weeks

  • Forced Expiratory Volume in 1 second (FEV1)

    FEV1 will be measured using basic spirometry and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)

    8 Weeks

  • Peak Expiratory Flow (PEF)

    PEF will be measured using basic spirometry and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)

    8 Weeks

  • Respiratory Muscle Strength - MIP

    Maximum Inspiratory Pressure (MIP) will be measured using MicroRPM portable manometer and the unit will be expressed in mmHg

    8 Weeks

  • Respiratory Muscle Strength - MEP

    Maximum Expiratory Pressure (MEP) will be measured using MicroRPM portable manometer and the unit will be expressed in mmHg

    8 Weeks

  • Six-minute walk test distance

    Distance walked in six minutes will be recorded in meters. Test will be conducted according to the guideline of American Thoracic Society (ATS)

    8 Weeks

  • M. Quadriceps strength

    sometric M. Quadriceps strength (kg) will be measured using electronic hand held dynamometer in sitting position.

    8 Weeks

Study Arms (2)

Cystic Fibrosis

EXPERIMENTAL

Children with cystic fibrosis

Other: Comprehensive Respiratory Physiotherapy

Bronchiectasis

EXPERIMENTAL

Children with bronchiectasis

Other: Comprehensive Respiratory Physiotherapy

Interventions

Comprehensive Respiratory PhysiotherapyOTHER

All patients will receive comprehensive respiratory physiotherapy training by the physiotherapist. All patients will undergo comprehensive respiratory physiotherapy techniques twice daily for 8 weeks. Comprehensive respiratory physiotherapy programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage, coughing techniques and teaching respiratory control.

BronchiectasisCystic Fibrosis

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being between 6-18 years old
  • Clinically diagnosed as cystic fibrosis or non-cystic fibrosis bronchiectasis

You may not qualify if:

  • Previous history of lung or liver transplantation
  • Have had an acute exacerbation in the last month and / or have a history of hospitalization
  • Having a diagnosis of orthopedic problems affecting mobility or a history of musculoskelatal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif Universitesi, Department of Physiotherapy and Rehabilitation

Istanbul, 34060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cystic FibrosisBronchiectasis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesBronchial Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 20, 2019

Study Start

January 1, 2020

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

November 3, 2020

Record last verified: 2020-11

Locations

TU(1)