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Trial registered on ANZCTR


Registration number
ACTRN12614000077662
Ethics application status
Approved
Date submitted
4/01/2014
Date registered
22/01/2014
Date last updated
22/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Noninvasive ventilation improves the cardiovascular response and fatigability during resistance exercise in patients with heart failure
Scientific title
effects of noninvasive ventilation on cardiovascular response and quadriceps fatigability during isokinetic resistance exercise in patients with heart failure
Secondary ID [1] 283844 0
none
Universal Trial Number (UTN)
U1111-1151-7534
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart failure 290818 0
cardiovascular diseases 290819 0
Condition category
Condition code
Cardiovascular 291187 291187 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 291242 291242 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants attended the isokinetic strength testing laboratory on three different days, with a minimum interval of 72 hours between each visit. On the first day, the study participants were familiarized with noninvasive ventilation (BIPAP Sycnrony II, Respironics Inc, Murrysville, PA, USA) and the isokinetic dynamometer. To select the bi-level positive airway pressure intervention (BV) pressures during exercise, the best inspiratory and expiratory positive airway pressure (inspiratory positive airway pressure (IPAP) and expiratory positive airway pressure (EPAP) respectively) were evaluated. The IPAP was initially set at 10 cmH2O and increased gradually by 2 cmH2O every minute to a maximum of 14 cmH2O. The EPAP was set at 4 cmH2O and increased gradually by 1 cmH2O every minute to a maximum of 8 cmH2O. The pressure level was set to individual subject tolerance for all study participants. The sham intervention (SV) was applied with minimal pressure support (IPAP 4 cmH2O and EPAP 2cmH2O). All participants received noninvasive ventilation via a facial mask interface (Comfort full 2 Mask, Respironics Inc, Murrysville, PA, USA) during both BV and SV.
On the second and third days, all subjects underwent a quadriceps isokineitc resistance exercise protocol utilizing both conditions of noninvasive ventilation (BV and SV). Subjects were randomly allocated to the BV or SV intervention before starting each procedure. First, all participants underwent 20 minutes of the allocated intervention (BV and SV) while at rest. During this initial period, the subjects sat on the isokinetic dynamometer (Biodex Medical System 2, Shirley, New York, USA).
The resistance maneuver for this study was concentric knee extension, on the dominant side, at a speed of 60 degress per second. Five sets of 10 repetitions were performed during the two exercise bouts and each set was separated by two minutes of rest. Positioning and stabilization of each participant was standardized. Correction for the effect of gravity was made. Change in peak torque (PT, expressed in Nm), total work (TW, expressed in J) and Power (Pw, expressed in W) between the fifth and first sets were also measured to evaluate quadriceps fatigability by isokinetic dynamometer. Verbal encouragement and visual feedback using the computer screen were given in an attempt to achieve a maximum level of effort. All procedures were performed by the same investigator. The validity and reliability of this testing procedure have been previously described.
At rest, during the resistance exercise protocol as well as during the recovery period, HR was continuously monitored (Polar model RS 800, Polar Electro Inc., Kempele, Finland). Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were also measured using a calibrated oscilometric automatic device (OMROM MIT elite plus, OMROM Health Care Inc, Illinois, USA).
Intervention code [1] 288524 0
Rehabilitation
Comparator / control treatment
On the second and third days, all subjects underwent a quadriceps isokineitc resistance exercise protocol utilizing both conditions of noninvasive ventilation (BV and SV). Subjects were randomly allocated to the BV or SV intervention before starting each procedure. First, all participants underwent 20 minutes of the allocated intervention (BV and SV) while at rest. During this initial period, the subjects sat on the isokinetic dynamometer (Biodex Medical System 2, Shirley, New York, USA).
Control group
Placebo

Outcomes
Primary outcome [1] 291175 0
cardiovascular response - At rest, during the resistance exercise protocol as well as during the recovery period, HR was continuously monitored (Polar model RS 800, Polar Electro Inc., Kempele, Finland). Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were also measured using a calibrated oscilometric automatic device (OMROM MIT elite plus, OMROM Health Care Inc, Illinois, USA).
Timepoint [1] 291175 0
at rest, peak exercise and recovery ( 5 minutos after exercise protocol)
Secondary outcome [1] 306186 0
quadriceps fatigability - the subjects sat on the isokinetic dynamometer (Biodex Medical System 2, Shirley, New York, USA).
The resistance maneuver for this study was concentric knee extension, on the dominant side, at a speed of 60 degrees per second. Five sets of 10 repetitions were performed during the two exercise bouts and each set was separated by two minutes of rest. Positioning and stabilization of each participant was standardized. Correction for the effect of gravity was made. Change in peak torque (PT, expressed in Nm), total work (TW, expressed in J) and Power (Pw, expressed in W) between the fifth and first sets were also measured by the isokinetic dynamometer. Verbal encouragement and visual feedback using the computer screen were given in an attempt to achieve a maximum level of effort . All procedures were performed by the same investigator. The validity and reliability of this testing procedure have been previously described.
Timepoint [1] 306186 0
Change in peak torque, total work and power between fifth and first sets

Eligibility
Key inclusion criteria
The recruited subjects satisfied the following inclusion criteria: 1) a diagnosis of HF 9 documented for at least 6 months, 2) echocardiography showing left ventricular systolic dysfunction < 35%, 3) New York Heart Association classification class II-III, and 4) No participation in either a resistance or aerobic training program for at least 3 months prior to study initiation
Minimum age
40 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Any subject with a previous diagnosis of moderate to severe chronic obstructive pulmonary disease or who were unable to perform the resistance isokinetic exercise protocol were excluded from this study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
he patients were randomly allocated to two groups by drawing lots, by placing blue and red ribbons inside opaque envelopes. Patients that chose an envelope containing a blue ribbon were allocated in the BV group, and those that chose the envelopes containing the red ribbon were allocated in the Sham group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
An a-prior analysis for this study revealed 9 subjects were needed to achieve 80% power (a = 0,05 and beta = 0.20). All analyses were carried out using a statistical software package (Graphpad Prism version 5 software, Graphpad software, Inc., La Jolla, CA, USA). Values for continuous variables were represented as mean and standard deviation. A two way analysis of variance (ANOVA) assessed differences in continuous variables between study subjects. Post-hoc analysis was performed by the Tukey test. Isokinetic measurements were evaluated by unpaired t- test. A p-value < 0.05 was considered statistically significant for all tests

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5714 0
Brazil
State/province [1] 5714 0
Distrito Federal

Funding & Sponsors
Funding source category [1] 288496 0
University
Name [1] 288496 0
University of Brasilia Brazil
Address [1] 288496 0
Centro Metropolitano
Conjunto A
Lote 01
Ceilandia
Brasilia - DF
ZIP: 72220-900
Country [1] 288496 0
Brazil
Primary sponsor type
University
Name
University of Brasilia Brazil
Address
Centro Metropolitano
Conjunto A
Lote 01
Ceilandia
Brasilia - DF
ZIP: 72220-900
Country
Brazil
Secondary sponsor category [1] 287199 0
Government body
Name [1] 287199 0
Centro Nacional de Desenvolvimento de Pesquisa CNPQ
Address [1] 287199 0
SHIS QI 1 Conjunto B - Blocos A, B, C e D
Lago Sul - Brasilia.DF - ZIP: 71605-001
Country [1] 287199 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290355 0
Instituo de Cardiologia do Distrito Federal
Ethics committee address [1] 290355 0
Instituto de Cardiologia do Distrito Federal
Estrada Parque Contorno do Bosque, s/n
Bairro: Cruzeiro Novo
Cidade: Brasilia - DF
ZIP: 70.658-700
Ethics committee country [1] 290355 0
Brazil
Date submitted for ethics approval [1] 290355 0
05/01/2010
Approval date [1] 290355 0
03/02/2010
Ethics approval number [1] 290355 0
none

Summary
Brief summary
previous studies have demonstrated that respiratory muscle unloading probably results in a better balance between oxygen supply and demand, with beneficial effects on dyspnea and reduced exertional leg discomfort during high intensity exercise in heart failure patients. However, the application of noninvasive ventilation during resistance exercise has not been evaluated in this population.
The aim of the current study was to evaluate: 1) the effects of noninvasive ventilation on knee extensor isokinetic resistance exercise performance in a heart failure cohort. We hypothesize that the use of noninvasive ventilation during this resistance exercise protocol would improve muscular performance and reduce leg fatigue
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45294 0
Mr Vinicius Zacarias Maldaner da Silva
Address 45294 0
Vinicius Zacarias Maldaner da Silva
SQSW 105 bloco F apto 413
Sudoeste Brasilia DF
ZIP 70670426
Country 45294 0
Brazil
Phone 45294 0
+55 61 35422490
Fax 45294 0
Email 45294 0
viniciusmaldaner@gmail.com
Contact person for public queries
Name 45295 0
Prof Gerson Cirpiano Jr
Address 45295 0
Gerson Cipriano Jr
Centro Metropolitano
Conjunto A
Lote 01
Ceilandia
Brasilia - DF
CEP: 72220-900
Country 45295 0
Brazil
Phone 45295 0
+55 61 81907111
Fax 45295 0
Email 45295 0
ciprianeft@gmail.com
Contact person for scientific queries
Name 45296 0
Prof Gerson Cirpiano Jr
Address 45296 0
Gerson Cipriano Jr
Centro Metropolitano
Conjunto A
Lote 01
Ceilandia
Brasilia - DF
CEP: 72220-900
Country 45296 0
Brazil
Phone 45296 0
+ 55 61 81907111
Fax 45296 0
Email 45296 0
ciprianeft@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary