Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05926453
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-18
First Post:
2023-06-12
Brief Title:
Assessment of Cardiorespiratory Fitness in Spondylarthritis
Sponsor:
Diakonhjemmet Hospital
Organization:
Diakonhjemmet Hospital
Study Overview
Official Title:
Validation of Indirect Estimation Against Direct Gas Measurements of Cardiorespiratory Fitness Using the Modified Balke Protocol on a Treadmill in Patients With Spondylarthritis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Spondyloarthritis is a chronic inflammatory joint disease that affects the spine and sacroiliac joints Most untreated patients eventually experience impaired mobility of the spine pain and reduced physical function Exercise is a cornerstone in the treatment of patients with spondylarthritis and it has been shown that high intensity exercise is just as effective in reducing disease activity as immunosuppressive medication Additionally patients with spondylarthritis have increased risk of cardiovascular disease both due to traditionally risk factors obesity high blood pressure etc but also due to chronic inflammation A maximal cardiopulmonary exercise test CPET is a measure of cardiorespiratory fitness that can be used to show progression of the exercise and which also is correlated to all-cause mortality and life expectancy
The investigators will validate an indirect maximal CPET against the gold standard with direct gas exchange measurements in patients with spondylarthritis The indirect test is less time consuming requires less sophisticated equipment has lesser requirements to test personnel and facilities and has less expenditures than the direct test With a validated indirect maximal CPET the test of cardiorespiratory fitness will be more accessible for patients with spondylarthritis both in-hospital but also municipal
The investigators will validate an indirect maximal CPET against the gold standard with direct gas exchange measurements in patients with spondylarthritis The indirect test is less time consuming requires less sophisticated equipment has lesser requirements to test personnel and facilities and has less expenditures than the direct test With a validated indirect maximal CPET the test of cardiorespiratory fitness will be more accessible for patients with spondylarthritis both in-hospital but also municipal
Detailed Description:
Spondylarthritis SpA is a chronic inflammatory disease which affects sacroiliac joints spine and peripheral joints with an onset usually before the age of 45 years The prevalence is approximately 15 and correlated to the distribution of the genotype HLA-B27 in the population Most untreated patients eventually experience limited mobility of the spine pain reduced physical function and fatigue There is a considerable likelihood for significantly impaired quality-of-life morbidity and work disability Exercise is a cornerstone in the treatment of patients with SpA and it has been shown that supervised high intensity interval training has equally positive effect on disease activity as biological immunomodulating treatment The inflammatory joint diseases have a high prevalence of comorbidities such as cardiovascular disease CVD driven by both traditional and non-traditional risk factors The CVDs are an important cause of premature mortality for patients with inflammatory joint diseases including SpA Traditional CVD risk factors such as obesity and lower levels of physical activity coupled with non-traditional risk factors such as systemic inflammation are key causal factors
Cardiorespiratory fitness is a strong predictor of all-cause mortality and life expectancy also for patients with SpA and improved cardiorespiratory fitness seems to reduce the risk of cardiovascular disease in a quantitative manner The gold standard for measurement of an individuals cardiopulmonary fitness expressed as the peak oxygen consumption VO2peak is considered as the direct gas exchange measurements during maximal exercise of large muscle groups such as running cycling or swimming However the direct gas exchange measurement is time-consuming and requires technical instrumentation and highly skilled personnel and it is therefore often more convenient to use estimates For the maximal exercise test to measure correct VO2peak levels or estimate correct physical fitness the participants must be willing and capable of pushing themselves with the assistance of cheering from the technical personnel otherwise the VO2peak will be underestimated It is therefore evident that the result of the performed test depends on the maximal effort being executed
The modified Balke protocol is a protocol often used in maximal cardiopulmonary exercise testing CPET on a treadmill According to this protocol the workload is increased by elevated inclination to a maximum of 15 If the participant is capable of further increased workload the speed of the treadmill is increased till exhaustion of the participant With the indirect test VO2peak is estimated from the time to exhaustion TTE incline of the treadmill and the speed of the treadmill The indirect test requires a treadmill with adjustable incline heart rate monitor and a stopwatch The direct VO2 measurement is performed with breath-by-breath gas exchange measurement of inspiratory and expiratory air by a Hans Rudolph mask and direct analysis using an ergospirometer system The direct gas measurements require expensive and sophisticated equipment as well as trained personnel to perform the test and this is not standard in many of the out-patient clinics Thus the indirect test is cheaper and less time-consuming for the participant and the health personnel making it a more accessible test of cardiorespiratory fitness than the directly measured gas exchange The indirect estimate of physical performance has to our knowledge not yet been validated against the direct gas measurement using the modified Balke protocol in patients with SpA
Hypothesis and research question The investigators hypothesise that the estimated VO2peak from the maximal CPET is well correlated to the VO2peak measured by direct gas measurements in patients with SpA
Tests Modified Balke protocol for maximal CPET All participants are asked not to eat for 2-hours prior to the test and to empty their bladder right before the start of measurements Ahead of the CPET participants will be familiarised with treadmill walking with a warm-up of 5 minutes at a 15 incline The output setting for the CPET is 45 incline and an estimated output level unfit woman 43 kmh-1 unfit mannormal woman 47 kmh-1 fit womannormal man 53 kmh-1 fit man 53 kmh-1 The incline is increased with 2 every minute when an incline of 15 is reached the pace of the treadmill is increased with 03 kmh-1 every minute while the inclination is kept constant 15 until participant exhaustion The test is complete when the participants reach their exhaustion point and are unable to continue the test despite verbal encouragement from the test technician The protocol is terminated in advance of exhaustion if the test technician observes abnormal andor adverse test values or the patient requests to stop Borg RPE 18 VO2 plateau two averaged 30-second consecutive measures age and gender specific reference values for respiratory exchange ratio blood lactate above age references and the maximal heart rate within 90 of the age-predicted maximum 211-064age are used to validate the CPET as a maximal CPET at test termination Participants who do not fulfil at least 2 of the 4 requirements will be excluded from analyses
Calculations
For the indirect estimates the maximal CPET data TTE inclination and speed is used for calculations of VO2peak There will use two equations for indirect calculations
The ACSM equation
VO2peak 01 speed ms-1 18 speedms-1 inclination 35
The HUNT3 equation
Men 2424 0599 inclination 397 speed - 0122 body weight - 0126 age Women 1721 0582 inclination 3317 speed - 0116 body weight - 0099 age The two formulas will be compared and validate these calculations against the direct CPET and the non-exercise formula from Kondiskalkulatoren World Fitness Level
Measurements The CPET will be performed on a treadmill with 12-lead ECG and scaled by the modified Borg RPE 6-20 Blood pressure is measured before test start mmHg and every other minute throughout the test Heart rate is measured continuously during the CPET and Borg RPE is reported every minute HRpeak is registered together with the time point of its occurrence Before the CPET height m body weight kg and circumference of hip cm and waist cm are measured Body composition is measured by bioelectrical impedance analysis BIA
Pulmonary function will be assessed by spirometer according to guidelines and forced expiratory volume FEV1 L forced vital capacity L and peak expiratory flow Lmin will be recorded from three attempts at maximal expiratory flow volume loops Maximal voluntary ventilation MVV Lmin will be measured twice by breathing deeply and rapidly for 12 seconds In cases of poor technique MVV will be estimated as FEV1 375 Gas exchange is measured through a Hans Rudolph two-way mask using a breath-by-breath gas analysing system VO2max is defined as the plateau VO2 of two 30-second samples and the VO2peak is defined as the highest VO2 measured during the test
Blood lactate concentration is measured in a small blood sample from the fingertip within 60 seconds of test completion to evaluate level of anaerobic processes CRP is measured in a small blood sample from the fingertip before the CPET for ASDAS calculations
Cardiorespiratory fitness is a strong predictor of all-cause mortality and life expectancy also for patients with SpA and improved cardiorespiratory fitness seems to reduce the risk of cardiovascular disease in a quantitative manner The gold standard for measurement of an individuals cardiopulmonary fitness expressed as the peak oxygen consumption VO2peak is considered as the direct gas exchange measurements during maximal exercise of large muscle groups such as running cycling or swimming However the direct gas exchange measurement is time-consuming and requires technical instrumentation and highly skilled personnel and it is therefore often more convenient to use estimates For the maximal exercise test to measure correct VO2peak levels or estimate correct physical fitness the participants must be willing and capable of pushing themselves with the assistance of cheering from the technical personnel otherwise the VO2peak will be underestimated It is therefore evident that the result of the performed test depends on the maximal effort being executed
The modified Balke protocol is a protocol often used in maximal cardiopulmonary exercise testing CPET on a treadmill According to this protocol the workload is increased by elevated inclination to a maximum of 15 If the participant is capable of further increased workload the speed of the treadmill is increased till exhaustion of the participant With the indirect test VO2peak is estimated from the time to exhaustion TTE incline of the treadmill and the speed of the treadmill The indirect test requires a treadmill with adjustable incline heart rate monitor and a stopwatch The direct VO2 measurement is performed with breath-by-breath gas exchange measurement of inspiratory and expiratory air by a Hans Rudolph mask and direct analysis using an ergospirometer system The direct gas measurements require expensive and sophisticated equipment as well as trained personnel to perform the test and this is not standard in many of the out-patient clinics Thus the indirect test is cheaper and less time-consuming for the participant and the health personnel making it a more accessible test of cardiorespiratory fitness than the directly measured gas exchange The indirect estimate of physical performance has to our knowledge not yet been validated against the direct gas measurement using the modified Balke protocol in patients with SpA
Hypothesis and research question The investigators hypothesise that the estimated VO2peak from the maximal CPET is well correlated to the VO2peak measured by direct gas measurements in patients with SpA
Tests Modified Balke protocol for maximal CPET All participants are asked not to eat for 2-hours prior to the test and to empty their bladder right before the start of measurements Ahead of the CPET participants will be familiarised with treadmill walking with a warm-up of 5 minutes at a 15 incline The output setting for the CPET is 45 incline and an estimated output level unfit woman 43 kmh-1 unfit mannormal woman 47 kmh-1 fit womannormal man 53 kmh-1 fit man 53 kmh-1 The incline is increased with 2 every minute when an incline of 15 is reached the pace of the treadmill is increased with 03 kmh-1 every minute while the inclination is kept constant 15 until participant exhaustion The test is complete when the participants reach their exhaustion point and are unable to continue the test despite verbal encouragement from the test technician The protocol is terminated in advance of exhaustion if the test technician observes abnormal andor adverse test values or the patient requests to stop Borg RPE 18 VO2 plateau two averaged 30-second consecutive measures age and gender specific reference values for respiratory exchange ratio blood lactate above age references and the maximal heart rate within 90 of the age-predicted maximum 211-064age are used to validate the CPET as a maximal CPET at test termination Participants who do not fulfil at least 2 of the 4 requirements will be excluded from analyses
Calculations
For the indirect estimates the maximal CPET data TTE inclination and speed is used for calculations of VO2peak There will use two equations for indirect calculations
The ACSM equation
VO2peak 01 speed ms-1 18 speedms-1 inclination 35
The HUNT3 equation
Men 2424 0599 inclination 397 speed - 0122 body weight - 0126 age Women 1721 0582 inclination 3317 speed - 0116 body weight - 0099 age The two formulas will be compared and validate these calculations against the direct CPET and the non-exercise formula from Kondiskalkulatoren World Fitness Level
Measurements The CPET will be performed on a treadmill with 12-lead ECG and scaled by the modified Borg RPE 6-20 Blood pressure is measured before test start mmHg and every other minute throughout the test Heart rate is measured continuously during the CPET and Borg RPE is reported every minute HRpeak is registered together with the time point of its occurrence Before the CPET height m body weight kg and circumference of hip cm and waist cm are measured Body composition is measured by bioelectrical impedance analysis BIA
Pulmonary function will be assessed by spirometer according to guidelines and forced expiratory volume FEV1 L forced vital capacity L and peak expiratory flow Lmin will be recorded from three attempts at maximal expiratory flow volume loops Maximal voluntary ventilation MVV Lmin will be measured twice by breathing deeply and rapidly for 12 seconds In cases of poor technique MVV will be estimated as FEV1 375 Gas exchange is measured through a Hans Rudolph two-way mask using a breath-by-breath gas analysing system VO2max is defined as the plateau VO2 of two 30-second samples and the VO2peak is defined as the highest VO2 measured during the test
Blood lactate concentration is measured in a small blood sample from the fingertip within 60 seconds of test completion to evaluate level of anaerobic processes CRP is measured in a small blood sample from the fingertip before the CPET for ASDAS calculations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None