The iStep Study: Development and Validation of an Incremental Exercise Step Test for Children With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

The iStep Study: Development and Validation of an Incremental Exercise Step Test for Children With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199340
• Other study ID #: 11AR14
• Status: Completed
• Phase: N/A
• First received: June 12, 2014
• Last updated: April 18, 2016
• Start date: July 2011
• Est. completion date: October 2014

Study information

• Verified date: April 2016
• Source: Great Ormond Street Hospital for Children NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

The progression of lung disease in cystic fibrosis (CF) results inevitably in a reduction in exercise capacity. The assessment of fitness and exercise capacity in CF is an important measure of the impact of the disease process, particularly if it is repeated over time. With recent advances in clinical management, CF lung disease in children can be relatively mild and exercise tolerance good. The currently available field tests e.g. 3 minute step test, are often completed too easily. These tests provide limited information relating to maximal exercise performance. By contrast, the maximal CardioPulmonary Exercise Test (CPET), a progressive, incremental, gold standard exercise test with breath by breath analysis of expired gas, has proved to be a valuable means of assessing exercise response in patients with CF. Its only limitation is the requirement for specialist laboratory facilities, equipment and staff.

A new field test for evaluating exercise capacity in children is needed. This should be portable, easy to administer and simple to perform by young children, while providing a higher intensity of exercise which correlates with day to day activity patterns of children, and clinically relevant information in the short term and longitudinally. This test needs to be a good surrogate measure of exercise capacity when formal CPET is unable to be undertaken. By providing accurate and useful information the results can be used to prescribe and train individuals with CF safely and effectively and can also be used in the short and long term for guidance of the medical management of these complex patients.

The aim of this study is to develop and validate the use of a new incremental step test to assess exercise tolerance/capacity in children with CF, compare this with the gold standard CPET and to provide normative healthy control comparison data The main objectives of the study are

1. To develop an incremental step test to assess exercise tolerance / capacity in children with CF.

2. To compare the incremental step test with the gold standard CPET

3. To assess the level of exercise response produced by the incremental step test

4. To assess the correlation between independent variables of lung function measurements, age, weight and height with VO2peak and other exercise test outcomes

5. To assess the repeatability and evaluate the normal variability of the new incremental step test

6. To provide healthy control normative data for comparison

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

Inclusion Criteria:

Clinical population inclusion

• Parental/guardian consent

• Participant assent

• Male or female

• Confirmed Cystic fibrosis diagnosis (by genetic genotype or positive sweat test)

• Receiving physiotherapy as part of their usual care

• Height >125cm to allow cycle ergometer use

• 6-16 years

Healthy control population inclusion

• Parental/guardian consent

• Participant assent

• Male or female

• 6-16 years

Exclusion Criteria:

Clinical population exclusion

• <6 years and >16 years

• No consent / assent

• Frank haemoptysis in the last 48 hours

• Acute infective exacerbation (defined as increased temperature, additional antibiotics)

• Poor dietary intake/hydration

• Oxygen dependent at rest

• Arterial oxygen saturation (SaO2) <90% at rest

• Burkholderia cepacia

• Coexisting insulin dependent diabetes mellitus

• Methicillin-resistant Staphylococcus aureus (MRSA) positive

Healthy control population exclusion

• <6 years and >16 years

• No consent / assent

• Acute infection (defined as increased temperature and antibiotics)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• iStep exercise test
newly developed submaximal exercise test
• CPET exercise test
maximal gold standard exercise test

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital for Children NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak oxygen uptake (VO2peak)	Gold standard exercise test to determine peak oxygen uptake during exercise	Measured during the exercise test, day 1, maximum of 20 minutes	No
Secondary	Secondary breath by breath analysis outcome measures		Measured during the exercise test, day 1, maximum of 20 minutes	No
Secondary	Newly developed iStep exercise test outcome variables	Standard field exercise test outcomes of heart rate, oxygen saturations, time, level achieved, rate of perceived exertion, perceived breathlessness	Measured during the exercise test, day 1, maximum of 20 minutes	No
Secondary	Height, weight and body mass index measures	Height, weight and body mass index will be measured for descriptive purposes only	Measured at baseline on the day of testing, day 1, maximum of 5 minutes	No
Secondary	Reasons for termination of the incremental step test		Measured at the end of the exercise test, day 1, maximum of 5 minutes	No