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NCT03295201

Clinical Effects of Exercise Program Added to Pulmonary Rehabilitation in Patients With Cystic Fibrosis

Completed NA Results posted Last updated 26 October 2018
What this trial tests

NA trial testing Active cycle of breathing techniques (ACBT) in Cystic Fibrosis in 22 participants. Completed in 24 November 2017.

Timeline
5 March 2017
Primary endpoint
23 October 2017
24 November 2017

Quick facts

Lead sponsorMarmara University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment22
Start date5 March 2017
Primary completion23 October 2017
Estimated completion24 November 2017
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Marmara University

Who can join

Adults 6 to 14, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Exercise Tolerance Primary · Before treatment

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.

GroupValue95% CI
Pulmonary Rehabilitation+Exercise Group817± 234.62
Pulmonary Rehabilitation Group792.22± 327.21
Exercise Tolerance Primary · 6 weeks

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.

GroupValue95% CI
Pulmonary Rehabilitation+Exercise Group980± 277.24
Pulmonary Rehabilitation Group1058.77± 594.67
Exercise Tolerance Primary · 3 months

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.

GroupValue95% CI
Pulmonary Rehabilitation+Exercise Group1104± 306.73
Pulmonary Rehabilitation Group1036.66± 457.16
Exercise Tolerance Primary · 6 months

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.

GroupValue95% CI
Pulmonary Rehabilitation+Exercise Group1251± 324.15
Pulmonary Rehabilitation Group1161.11± 594.06
Quality of Life Secondary · Before treatment

The Cystic Fibrosis Questionnaire-Revised (CFQR) is used to measure the quality of life. This scale is found to be valid and reliable in Turkish. The child version of this test consists 35 questions about physical function, emotional function, social function, body appearance, eating disorders, treatment difficulties, respiratory and digestive symptoms. The total score is calculated between 0-100 and higher scores define the better condition.

GroupValue95% CI
Pulmonary Rehabilitation+Exercise Group86.4± 5.75
Pulmonary Rehabilitation Group92.77± 9.94
Quality of Life Secondary · 6 weeks

The Cystic Fibrosis Questionnaire-Revised (CFQR) is used to measure the quality of life. This scale is found to be valid and reliable in Turkish. The child version of this test consists 35 questions about physical function, emotional function, social function, body appearance, eating disorders, treatment difficulties, respiratory and digestive symptoms. The total score is calculated between 0-100 and higher scores define the better condition.

GroupValue95% CI
Pulmonary Rehabilitation+Exercise Group88.9± 7.04
Pulmonary Rehabilitation Group90.88± 13.37
Quality of Life Secondary · 3 months

The Cystic Fibrosis Questionnaire-Revised (CFQR) is used to measure the quality of life. This scale is found to be valid and reliable in Turkish. The child version of this test consists 35 questions about physical function, emotional function, social function, body appearance, eating disorders, treatment difficulties, respiratory and digestive symptoms. The total score is calculated between 0-100 and higher scores define the better condition.

GroupValue95% CI
Pulmonary Rehabilitation+Exercise Group87.2± 5.57
Pulmonary Rehabilitation Group93.33± 11.35
Quality of Life Secondary · 6 months

The Cystic Fibrosis Questionnaire-Revised (CFQR) is used to measure the quality of life. This scale is found to be valid and reliable in Turkish. The child version of this test consists 35 questions about physical function, emotional function, social function, body appearance, eating disorders, treatment difficulties, respiratory and digestive symptoms. The total score is calculated between 0-100 and higher scores define the better condition.

GroupValue95% CI
Pulmonary Rehabilitation+Exercise Group89.7± 7.84
Pulmonary Rehabilitation Group95.55± 12.64
Postural Stability Secondary · Before treatment

The Balance Master Device- Limits of Stability Test (LOS) is used for to measure the postural stability of children. The LOS consists a 18x60 inch of a pressure platform which connected to a computer system. The patient is asked to stand on the platform barefoot and watch the image which can be moved by trunk movement on the computer the monitor. It is required to move the image towards to target points on the monitor with commands. Reaction time, movement velocity, endpoint excursion, maximum excursion and direction control parameters are calculated during these trunk movements. Reaction time

GroupValue95% CI
Pulmonary Rehabilitation+Exercise Group1.29± 0.85
Pulmonary Rehabilitation Group1.03± 0.53
Postural Stability Secondary · 6 weeks

The Balance Master Device- Limits of Stability Test (LOS) is used for to measure the postural stability of children. The LOS consists a 18x60 inch of a pressure platform which connected to a computer system. The patient is asked to stand on the platform barefoot and watch the image which can be moved by trunk movement on the computer the monitor. It is required to move the image towards to target points on the monitor with commands. Reaction time, movement velocity, endpoint excursion, maximum excursion and direction control parameters are calculated during these trunk movements. Reaction time

GroupValue95% CI
Pulmonary Rehabilitation+Exercise Group0.91± 0.66
Pulmonary Rehabilitation Group0.83± 0.65
Postural Stability Secondary · 3 months

The Balance Master Device- Limits of Stability Test (LOS) is used for to measure the postural stability of children. The LOS consists a 18x60 inch of a pressure platform which connected to a computer system. The patient is asked to stand on the platform barefoot and watch the image which can be moved by trunk movement on the computer the monitor. It is required to move the image towards to target points on the monitor with commands. Reaction time, movement velocity, endpoint excursion, maximum excursion and direction control parameters are calculated during these trunk movements. Reaction time

GroupValue95% CI
Pulmonary Rehabilitation+Exercise Group0.88± 0.72
Pulmonary Rehabilitation Group0.65± 0.52
Postural Stability Secondary · 6 months

The Balance Master Device- Limits of Stability Test (LOS) is used for to measure the postural stability of children. The LOS consists a 18x60 inch of a pressure platform which connected to a computer system. The patient is asked to stand on the platform barefoot and watch the image which can be moved by trunk movement on the computer the monitor. It is required to move the image towards to target points on the monitor with commands. Reaction time, movement velocity, endpoint excursion, maximum excursion and direction control parameters are calculated during these trunk movements. Reaction time

GroupValue95% CI
Pulmonary Rehabilitation+Exercise Group1.15± 0.69
Pulmonary Rehabilitation Group0.92± 0.46

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Physical activity and exercise training in cystic fibrosis.
    Radtke T, Smith S, Nevitt SJ, Hebestreit H, et al · · 2022 · cited 31× · PMID 35943025 · DOI 10.1002/14651858.cd002768.pub5
  2. Exercise versus airway clearance techniques for people with cystic fibrosis.
    Heinz KD, Walsh A, Southern KW, Johnstone Z, et al · · 2022 · cited 18× · PMID 35731672 · DOI 10.1002/14651858.cd013285.pub2
  3. The clinical effects of combining postural exercises with chest physiotherapy in cystic fibrosis: A single-blind, randomized-controlled trial.
    Güngör S, Gencer-Atalay K, Bahar-Özdemir Y, Keniş-Coşkun Ö, et al · · 2021 · cited 7× · PMID 33948549 · DOI 10.5606/tftrd.2021.5214
  4. Physical therapies for postural abnormalities in people with cystic fibrosis.
    Oliveira VH, Mendonça KM, Monteiro KS, Silva IS, et al · · 2020 · cited 4× · PMID 32227599 · DOI 10.1002/14651858.cd013018.pub2

Verify or expand the search:

Other recruiting trials for Cystic Fibrosis

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03295201.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing