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

NCT ID: NCT02199340

Last Updated: 2016-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-10-31

Brief 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

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cystic fibrosis

• iStep exercise test
• CPET exercise test

Group Type: EXPERIMENTAL

iStep exercise test

Intervention Type: OTHER

newly developed submaximal exercise test

CPET exercise test

Intervention Type: OTHER

maximal gold standard exercise test

Healthy control

\- iStep exercise test

Group Type: ACTIVE_COMPARATOR

iStep exercise test

Intervention Type: OTHER

newly developed submaximal exercise test

Interventions

iStep exercise test

newly developed submaximal exercise test

Intervention Type: OTHER

CPET exercise test

maximal gold standard exercise test

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Rand, BA, BSc, MSc

Role: PRINCIPAL_INVESTIGATOR

UCL Institute of Child Health

Locations

Great Ormond Street Hospital for Children NHS Foundation Trust

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

11AR14

Identifier Type: -

Identifier Source: org_study_id