NCT03295201

Brief Summary

The aim of this study is to investigate the effects of postural exercise program added to pulmonary rehabilitation program on quality of life, exercise tolerance and postural stability in children with Cystic Fibrosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2017

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 26, 2018

Completed
Last Updated

October 26, 2018

Status Verified

January 1, 2018

Enrollment Period

8 months

First QC Date

August 23, 2017

Results QC Date

October 24, 2017

Last Update Submit

January 25, 2018

Conditions

Cystic Fibrosis

Keywords

Cystic FibrosisPostural exercisePulmonary rehabilitation

Outcome Measures

Primary Outcomes (4)

  • Exercise Tolerance

    Modified Shuttle Test (MST) is used to measure the exercise tolerance. The patient is asked to walk until feeling tired between two fixed objects with a 10-meter interval, starting at normal walking speed and increasing the speed at the beginning of each minute. Maximum distance (meters) is measured for the test.

    Before treatment

  • Exercise Tolerance

    Modified Shuttle Test (MST) is used to measure the exercise tolerance. The patient is asked to walk until feeling tired between two fixed objects with a 10-meter interval, starting at normal walking speed and increasing the speed at the beginning of each minute. Maximum distance (meters) is measured for the test.

    6 weeks

  • Exercise Tolerance

    Modified Shuttle Test (MST) is used to measure the exercise tolerance. The patient is asked to walk until feeling tired between two fixed objects with a 10-meter interval, starting at normal walking speed and increasing the speed at the beginning of each minute. Maximum distance (meters) is measured for the test.

    3 months

  • Exercise Tolerance

    Modified Shuttle Test (MST) is used to measure the exercise tolerance. The patient is asked to walk until feeling tired between two fixed objects with a 10-meter interval, starting at normal walking speed and increasing the speed at the beginning of each minute. Maximum distance (meters) is measured for the test.

    6 months

Secondary Outcomes (20)

  • Quality of Life

    Before treatment

  • Quality of Life

    6 weeks

  • Quality of Life

    3 months

  • Quality of Life

    6 months

  • Postural Stability

    Before treatment

  • +15 more secondary outcomes

Study Arms (2)

Pulmonary rehabilitation+exercise group

EXPERIMENTAL

Active cycle of breathing techniques (ACBT) and postural exercise program

Other: Active cycle of breathing techniques (ACBT)Other: Postural Exercise

Pulmonary rehabilitation group

ACTIVE COMPARATOR

Active cycle of breathing techniques (ACBT)

Other: Active cycle of breathing techniques (ACBT)

Interventions

Active cycle of breathing techniques (ACBT)OTHER

ACBT involves three phases (Breathing control, chest expansion exercise, and huff coughing). These phases will apply with a sequence to remove secretion. ACBT will apply 1 per a week for 6 weeks.

Pulmonary rehabilitation groupPulmonary rehabilitation+exercise group
Postural ExerciseOTHER

Postural exercise program will include thoracic vertebra mobilization, pectoral stretching, scapula and thoracic extensors strengthening and core stability exercises. Postural exercise program will apply 1 per a week for 6 weeks.

Pulmonary rehabilitation+exercise group

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Be diagnosed with KF
  • Be able to understand commands

You may not qualify if:

  • FEV1 below than %30
  • Cor pulmonale
  • Advanced gastroesophageal reflux
  • Current hospital admission due to lung infection
  • Be diagnosed with neuromuscular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (5)

  • Edwards J, Clarke A, Greenop D. Adults with cystic fibrosis - responding to a new ageing population. Chronic Illn. 2013 Dec;9(4):312-9. doi: 10.1177/1742395313479982. Epub 2013 May 23.

    PMID: 23702786BACKGROUND

  • Barker N, Raghavan A, Buttling P, Douros K, Everard ML. Thoracic Kyphosis is Now Uncommon Amongst Children and Adolescents with Cystic Fibrosis. Front Pediatr. 2014 Feb 17;2:11. doi: 10.3389/fped.2014.00011. eCollection 2014.

    PMID: 24596827BACKGROUND

  • Tattersall R, Walshaw MJ. Posture and cystic fibrosis. J R Soc Med. 2003;96 Suppl 43(Suppl 43):18-22. No abstract available.

    PMID: 12906321BACKGROUND

  • Daniels T. Physiotherapeutic management strategies for the treatment of cystic fibrosis in adults. J Multidiscip Healthc. 2010 Nov 19;3:201-12. doi: 10.2147/JMDH.S8878.

    PMID: 21289861BACKGROUND

  • Massery M. Musculoskeletal and neuromuscular interventions: a physical approach to cystic fibrosis. J R Soc Med. 2005;98 Suppl 45(Suppl 45):55-66.

    PMID: 16025768BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Kardelen Gencer Atalay
Organization
Marmara University
kardelengencer@gmail.com
5324404887

Study Officials

  • Evrim Karadag Saygi, MD, Prof

    Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

August 23, 2017

First Posted

September 27, 2017

Study Start

March 5, 2017

Primary Completion

October 23, 2017

Study Completion

November 24, 2017

Last Updated

October 26, 2018

Results First Posted

October 26, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)