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CompletedNCT04153448Updated Jan 31, 2020

Comparison of Sit-to-stand Test With Six-minute Walk Test in Bronchiectasis and Healthy Children

An observational study in Bronchiectasis, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-31.

Sponsored by Bezmialem Vakif University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
6 Years to 18 Years
Sex
All
01

Study summary

Children with bronchiectasis and age-matched healthy controls will be evaluated with sit-to-stand test and six-minute walk test and utilization of STST in determining functional capacity will be investigated.

Read the detailed description

Bronchiectasis (BE) is a chronic condition which is characterized by the permanent abnormal widening of the bronchi as a result of repetitive airway infections and inflammation. Disabling cough and shortness of breath, excess mucus production, progressive airway obstruction and loss of skeletal muscle mass are the primary factors that impairs exercise tolerance in BE patients. Imaging modalities and pulmonary function test are insufficient to determine disease burden or the prognosis thus it is stated that exercise tolerance and quality of life should also be evaluated in these patients.

Exercise tolerance can be evaluated using cardiopulmonary exercise test by directly measuring oxygen consumption but the field tests such as six-minute walk test (6MWT), shuttle walk test or stair climbing tests also provides reliable data on exercise tolerance by measuring functional capacity. Among field tests, 6MWT is the most commonly used test for evaluating functional capacity in cardiopulmonary patients. Although 6MWT is easy to apply and does not require any special equipment, it still requires a 30-m long corridor and a total testing time of approx. 20 minutes considering the pre- and post-test resting periods which may impair its feasibility in some clinical settings.

Sit-to-stand test (STST) is firstly developed for older population to measure mobility related function and physical performance. Today, it is widely used in various populations including cardiopulmonary diseases such as cystic fibrosis, chronic obstructive pulmonary disease and heart failure. The investigator's aim in this study is to investigate whether STST is utilizable for evaluating functional capacity in children with BE.

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Conditions studied

  • Bronchiectasis

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Keywords

  • Bronchiectasis
  • Exercise capacity
  • Six-minute walk test
  • Sit-to-stand test
03

In context

Bronchiectasis

368 studies on the registry are indexed under Bronchiectasis; 104 are open to participants now.

This study's enrollment of 80 is below the median of 160 across 132 observational studies indexed under Bronchiectasis.

Browse Bronchiectasis studies →

Lead sponsor

Bezmialem Vakif University is the lead sponsor of 345 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Children diagnosed with non-cystic fibrosis bronchiectasis and age matched healthy volunteers who do not have any diagnosed chronic diseases

Inclusion criteria

  • Diagnosis of non-cystic fibrosis bronchiectasis

Exclusion criteria

Exclusion Criteria:

  • Hospitalization history in past month
  • Diagnosis of other chronic pediatric diseases which may impair exercise tolerance such as cerebral palsy or neuromuscular disease
  • Candidates for lung transplantation or history of lung transplantation
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • Bronchiectasis

    Children with bronchiectasis

    Other: Measurement of functional capacity

  • Healthy Controls

    Age-matched healthy volunteers

    Other: Measurement of functional capacity

Interventions

  • OtherMeasurement of functional capacity

    Functional capacity of participants will be measured with six-minute walk test and sit-to-stand test

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What researchers measure

Primary outcomes

  1. Six-minute walk test distance

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

    Time frame: 15 minutes

Secondary outcomes

  1. Number of repetitions in sit-to-stand test

    Participants will be asked to perform sit-to-stand maneuver as fast as possible for 30 seconds and the number of completed repetitions will be recorded.

    Time frame: 1 Minute

  2. 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)

    Time frame: 5 minutes

  3. 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)

    Time frame: 5 minutes

  4. 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)

    Time frame: 5 minutes

  5. M. Quadriceps strength

    Isometric M. Quadriceps strength will be measured using electronic hand held dynamometer in sitting position.

    Time frame: 3 minutes

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Study locations

1 site
  • Bezmialem Vakif University
    Istanbul, Turkey
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04153448
Lead sponsor
Bezmialem Vakif University
Responsible party
Melih Zeren (Assistant Professor, Bezmialem Vakif University) — Principal investigator
First posted
Nov 6, 2019
Start date
Dec 23, 2019
Primary completion
Jan 30, 2020
Completion
Jan 30, 2020
Last update
Jan 31, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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