Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02717650




Registration number
NCT02717650
Ethics application status
Date submitted
10/03/2016
Date registered
24/03/2016

Titles & IDs
Public title
The Alfred Step Test Exercise Protocol (A-STEP), for Adults With Cystic Fibrosis.
Scientific title
Development; Feasibility/Safety and Validation of the Alfred Step Test Exercise Protocol (A-STEP) Developed for Adults With Cystic Fibrosis:
Secondary ID [1] 0 0
205/16
Secondary ID [2] 0 0
205/16
Universal Trial Number (UTN)
Trial acronym
A-STEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Fibrosis 0 0
Lung Diseases 0 0
Respiratory Diseases 0 0
Genetic Diseases 0 0
Pancreatic Diseases 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - A-STEP
Other interventions - A-STEP (New Protocol)
Other interventions - Comparator: CPET cycle ergometer (Gold Standard)

Experimental: A-STEP - Study A) A-STEP Study Development of new exercise test protocol and Observational Feasibility/Safety Study (no comparator).

Experimental: A-STEP (New Protocol) - Study B) A-STEPmax Study Validity Study (random allocation of test order).

Active comparator: CPET cycle ergometer (Gold Standard) - Study B) A-STEPmax Study Validity Study (random allocation of test order).


Other interventions: A-STEP
Study A) Study A) Development of new exercise test protocol and Observational Feasibility/Safety Study (no comparator).

Feasibility/safety of a newly designed, incremental, maximal, standardised step test in adults with Cystic Fibrosis.

Other interventions: A-STEP (New Protocol)
Study B) Validation Study (random allocation of test order). Validity of an incremental, maximal, standardised incremental step test with breath-by-breath gas analysis using portable metabolic measurement equipment against CPET.

Other interventions: Comparator: CPET cycle ergometer (Gold Standard)
Study B) Validation study (random allocation of test order) "Gold standard" CPET. An incremental, maximal standardised cycle ergometer exercise test (performed as per published protocol) using portable metabolic measurement equipment.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Study B) Maximum oxygen uptake (VO2max)
Timepoint [1] 0 0
Measured during the incremental test for a maximum of 15 minutes.
Primary outcome [2] 0 0
Study A) Oxygen Saturation
Timepoint [2] 0 0
Measured for 3 min prior to exercise (recorded at baseline sitting and standing), monitored during the test (recorded at minute intervals) and for at least 2 min of recovery up to a maximum of 10 minutes.
Primary outcome [3] 0 0
Study A) Heart Rate
Timepoint [3] 0 0
Measures for 3 min prior to exercise (recorded at baseline sitting and standing), monitored during the test (recorded at minute intervals) and for at least 2 min of recovery up to a maximum of 10 minutes.
Secondary outcome [1] 0 0
Study B) Carbon Dioxide Production
Timepoint [1] 0 0
Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.
Secondary outcome [2] 0 0
Study B) Respiratory Exchange Ratio
Timepoint [2] 0 0
Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.
Secondary outcome [3] 0 0
Study B) Minute Ventilation
Timepoint [3] 0 0
Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.
Secondary outcome [4] 0 0
Study B) Oxygen Pulse
Timepoint [4] 0 0
Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.
Secondary outcome [5] 0 0
Study B) Tidal Volume
Timepoint [5] 0 0
Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.
Secondary outcome [6] 0 0
Study B) Oxygen Saturation
Timepoint [6] 0 0
easures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery
Secondary outcome [7] 0 0
Study B) Heart rate
Timepoint [7] 0 0
easures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery
Secondary outcome [8] 0 0
Study B) Measures from Electrocardiogram
Timepoint [8] 0 0
easures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery
Secondary outcome [9] 0 0
Study A & B) Breathlessness and Leg Fatigue
Timepoint [9] 0 0
Measures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery
Secondary outcome [10] 0 0
Study A & B) Blood pressure
Timepoint [10] 0 0
Measures are takenpre/post A-STEP, pre/every 2 mins during/post CPET
Secondary outcome [11] 0 0
Study A & B) Duration of test; Highest level (mins and sec)/stage achieved; Reason for test termination.
Timepoint [11] 0 0
Measured during or on completion of the test. Maximum 15 minutes.

Eligibility
Key inclusion criteria
INCLUSION

* Confirmed Diagnosis of CF (by genotype or positive sweat test)
* Aged 18yrs and older
* FEV1 =20% (Forced expiration in 1 sec)
* Stable baseline state. (Stable baseline state is defined as: clinically stable respiratory status, for at least 30 days, characterized by the absence of hospitalization and no changes in maintenance therapy during this period (Yankaskas et al 2004)).

EXCLUSION

* Febrile
* Haemoptysis
* Uncontrolled asthma
* Pneumothorax
* Cardiac issues
* Unreliable readings on pulse oximetry
* Pulmonary hypertension
* Unstable CF related diabetes (CFRD)
* Vascular issues
* Renal disease
* Pregnancy
* Body mass index (BMI) <18.0
* Significant musculoskeletal issues
* Unable to safely follow instructions

(ATS/ACCP 2003; Hebestreit 2015)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lisa M Wilson, BHS(Physio)
Address 0 0
Alfred Hospital; Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lisa M Wilson, BHS(Physio)
Address 0 0
Country 0 0
Phone 0 0
0390763450
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No plan to share individual patient data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Wilson LM, Ellis MJ, Lane RL, Wilson JW, Keating D... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT02717650