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The Alfred Step Test Exercise Protocol (A-STEP), for Adults With Cystic Fibrosis. (A-STEP)

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ClinicalTrials.gov Identifier: NCT02717650
Recruitment Status : Suspended (Validation study suspended due to Covid-19 restrictions-will resume when able)
First Posted : March 24, 2016
Last Update Posted : July 23, 2020
Sponsor:
Collaborator:
Monash University
Information provided by (Responsible Party):
Lisa Wilson, The Alfred

Brief Summary:

Exercise testing has become clinically important in the management and ongoing evaluation of patients with Cystic Fibrosis (CF) with higher rates of exercise tolerance and participation previously linked to lower mortality risk (1).

Lower exercise capacity generally correlates with more severe lung disease (2,3) and landmark studies suggest that low exercise capacity as measured by peak oxygen capacity (VO2peak) and rate of decline in lung function (FEV1) are strong predictors of mortality (1,4). However not all studies have found pulmonary function tests (PFTs) to be reliable predictors of maximal exercise capacity (5), especially in relatively well preserved lung function (6,7).

The wide distribution in physical capacity between fit individuals and end stage disease adds to complexity of assessment. Independent factors of age, genetics, habitual exercise, nutritional status and musculoskeletal conditions are all known to influence physical capacity in patients with CF (8,9).

Maximal exercise testing places additional stress on cardiovascular, respiratory and peripheral systems providing more information around multiple influences on disease progression including degree of limitation in these major systems (10,11) and is useful for assessment of exercise desaturation, more common (but not always present) in advanced lung disease (5,12).

With prediction of exercise performance and functional capacity from PFTs unreliable and the understanding that health status correlates better with exercise tolerance there has been an increase in maximal exercise testing for patient management (13). Many international centers now regard exercise testing as highly important with many assessing maximal exercise capacity annually to monitor disease progression, identify physical status and drive changes in medical, physiotherapy or nutritional management (14,15).

The main vision is to develop a standardized incremental step test protocol suitable for adults with Cystic Fibrosis (CF), all ages, levels of fitness and disease state that is in line with current exercise testing recommendations (15). To develop a more useful field test to assess exercise tolerance and a more "user friendly" test than the currently available laboratory exercise test to allow for early detection of decline in physical function in the day-to-day clinical setting. To date no studies have been published in adults with CF where an incremental exercise step test has been investigated to assess exercise tolerance or determine maximum oxygen uptake (VO2max).


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Fibrosis Lung Diseases Respiratory Diseases Genetic Diseases Pancreatic Diseases Other: A-STEP Other: A-STEP (New Protocol) Other: Comparator: CPET cycle ergometer (Gold Standard) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Development; Feasibility/Safety and Validation of the Alfred Step Test Exercise Protocol (A-STEP) Developed for Adults With Cystic Fibrosis:
Actual Study Start Date : August 25, 2016
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: A-STEP
Study A) A-STEP Study Development of new exercise test protocol and Observational Feasibility/Safety Study (no comparator).
Other: 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 Name: Alfred Step Test Exercise Protocol (A-STEP)

Experimental: A-STEP (New Protocol)
Study B) A-STEPmax Study Validity Study (random allocation of test order).
Other: 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 Name: Alfred Step Test Exercise Protocol

Active Comparator: CPET cycle ergometer (Gold Standard)
Study B) A-STEPmax Study Validity Study (random allocation of test order).
Other: 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.
Other Name: Cardiopulmonary Exercise Test Protocol




Primary Outcome Measures :
  1. Study B) Maximum oxygen uptake (VO2max) [ Time Frame: Measured during the incremental test for a maximum of 15 minutes. ]
    The highest oxygen uptake achieved during the exercise test taken from inspired gas in a given period of time. Body weight is used to calculate this from oxygen consumption during the test. VO2peak may be used as a surrogate if VO2max is not achieved. Criteria for reaching maximum effort is not included in this document.

  2. Study A) Oxygen Saturation [ Time Frame: 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. ]
    Standard objective outcome measures of field exercise testing. Measured via pulse oximetry.

  3. Study A) Heart Rate [ Time Frame: 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. ]
    Standard objective outcome measures of field exercise testing. Measured via pulse oximetry.


Secondary Outcome Measures :
  1. Study B) Carbon Dioxide Production [ Time Frame: Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery. ]
    Standard secondary outcome measure of maximal exercise testing using breath- by-breath gas analysis with portable metabolic measurement equipment.

  2. Study B) Respiratory Exchange Ratio [ Time Frame: Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery. ]
    Standard secondary outcome measure of maximal exercise testing using breath- by-breath gas analysis. The ratio of carbon dioxide production to oxygen consumption.

  3. Study B) Minute Ventilation [ Time Frame: Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery. ]
    Standard secondary outcome measure of maximal exercise testing using breath- by-breath gas analysis. The product of tidal volume and respiratory rate.

  4. Study B) Oxygen Pulse [ Time Frame: Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery. ]
    Standard secondary outcome measure of maximal exercise testing using breath- by-breath gas analysis. Calculated by dividing the oxygen consumption by heart rate.

  5. Study B) Tidal Volume [ Time Frame: Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery. ]
    Standard secondary outcome measure of maximal exercise testing using breath- by-breath gas analysis. The volume of each breath taken.

  6. Study B) Oxygen Saturation [ Time Frame: easures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery ]
    Standard objective outcome measures of exercise testing. Measured via pulse oximetry.

  7. Study B) Heart rate [ Time Frame: easures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery ]
    Standard objective outcome measures of exercise testing. Measured via pulse oximetry.

  8. Study B) Measures from Electrocardiogram [ Time Frame: easures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery ]
    Used to monitor the patient's cardiac rhythm (CPET only)

  9. Study A & B) Breathlessness and Leg Fatigue [ Time Frame: Measures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery ]
    Standard subjective outcome measures of exercise testing. Modified Borg 0-10.

  10. Study A & B) Blood pressure [ Time Frame: Measures are takenpre/post A-STEP, pre/every 2 mins during/post CPET ]
    Standard outcome measure of exercise testing.

  11. Study A & B) Duration of test; Highest level (mins and sec)/stage achieved; Reason for test termination. [ Time Frame: Measured during or on completion of the test. Maximum 15 minutes. ]
    Parameters of exercise test.


Other Outcome Measures:
  1. Study A & B) Gender; Age, Height, BMI, fitness level [ Time Frame: Recorded on the day of testing maximum 10 mins. ]
    Demographic baseline descriptive measures.

  2. Study A & B) Spirometry (Pulmonary Function Tests) [ Time Frame: Recorded on the day of testing prior to testing, maximum 10 minutes Study B. Most recent PFTs if day of testing lung function is not available study A. ]
    Baseline Pulmonary Function Test measures.

  3. Study A & B) Alfred Wellness Score for CF (AweScore CF) [ Time Frame: Recorded on the day of testing prior to testing, maximum 2 minutes. ]
    Alfred specific clinical tools: quality of life measure.

  4. Study A) Musculoskeletal Assessment Tool-Quick Screen [ Time Frame: Recorded on the day of testing, maximum 20 minutes. ]
    Alfred specific clinical tool: to screen for musculoskeletal issues.

  5. Study A & B) Medical history. [ Time Frame: Recorded on the day of testing, maximum 10 minutes. ]
    Baseline descriptive measures of health status.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717650


Locations
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Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
The Alfred
Monash University
Investigators
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Principal Investigator: Lisa M Wilson, BHS(Physio) Alfred Hospital; Monash University
Additional Information:
Publications:
Sykes, K., Roberts, A. . (2004). The Chester step test-a simple yet effective tool for the prediction of aerobic capacity. Physiotherapy Theory & Practice, 90(4 ), 183-188 doi: DOI: 10.1016/j.physio.2004.03.008)
Planner, S., Morrison, L., Campbell, J., Bicknell, S., Ross, E. (2007). The Chester Step Test-Is this a Valid Predictor of Disease Severity in Adult CF? . Paper presented at the 2007 Cystic Fibrosis Conference.

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Responsible Party: Lisa Wilson, Senior Physiotherapist, The Alfred
ClinicalTrials.gov Identifier: NCT02717650    
Other Study ID Numbers: 205/16
205/16 ( Other Identifier: The Alfred Ethics Committee )
0267 ( Other Identifier: Human Ethics Committee Monash University )
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share individual patient data.
Keywords provided by Lisa Wilson, The Alfred:
Exercise Testing
Maximal Exercise Testing
Maximal Exercise Capacity
Peak Exercise Capacity
Adults
Step Tests
Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases
Genetic Diseases, Inborn
Fibrosis
Pathologic Processes
Digestive System Diseases
Infant, Newborn, Diseases