Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000375055
Ethics application status
Approved
Date submitted
6/05/2010
Date registered
11/05/2010
Date last updated
11/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Inspiratory muscular training of chronic stroke survivors
Scientific title
Effect of inspiratory muscle training on chronic stroke survivors' inspiratory muscle strength, endurance and functional performance.
Secondary ID [1] 251700 0
nil
Universal Trial Number (UTN)
U1111-1114-8898
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic stroke survivors 257293 0
Condition category
Condition code
Physical Medicine / Rehabilitation 257441 257441 0 0
Physiotherapy
Stroke 257454 257454 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a home-based inspiratory muscle training: the training sessions consist of 30 minutes daily, five times per week over eight weeks with the threshold device regulated at 30% of the subjects’ maximal inspiratory pressure (MIP)values. Every other week (bi-weekly), one session was performed with physiotherapy supervision to measure the MIP and adjuste the load and also to check the information about the training and resolve any doubts. So, in one week the participants train five days on their own and on the other week four days on their own and one day with physiotherapy supervision.
Intervention code [1] 256426 0
Rehabilitation
Comparator / control treatment
control group using the same protocol with the threshold device without the resistance valve.
Control group
Placebo

Outcomes
Primary outcome [1] 258361 0
inspiratory muscular strength: assessed by manovacuometer with operational intervals of 300 cmH2O, in deep inspiration from residual volume against an occluded airway with a minor air leak (2 mm). The highest pressure of three measurements was used for analysis.
Timepoint [1] 258361 0
Baseline and after eight weeks of intervention
Primary outcome [2] 258396 0
inspiratory muscle endurance: an incremental test in which participants breath continuously through a mouthpiece connected to a Threshold Inspiratory Muscle Trainer with an initial load of 30% of Pimax, and increments of 10% of Pimax added every 2 min until the participant is unable to continue breathing. The greatest inspiratory pressure that the subject is able to sustain for at least 1 min is considered according to Martyn et al, 1987.
Timepoint [2] 258396 0
Baseline and after eight weeks of intervention
Secondary outcome [1] 264094 0
functional performance: incremental cycle ergometer test, protocol according to American College of Sports Medicine for persons with stroke consisting of stages of 2 minutes with incremental load calculated individualy using the Wasserman's formula.
Timepoint [1] 264094 0
Baseline and after eight weeks of intervention
Secondary outcome [2] 264095 0
Quality of life assessed by Nottingham Health Profile
Timepoint [2] 264095 0
Baseline and after eight weeks of intervention

Eligibility
Key inclusion criteria
stroke at least nine months before the study (to ensure chronicity) with maximal inspiratory pressure values lower than 90% of the predicted those adjusted for age and gender
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
facial palsys; restrictions in lung functions; cardiac or orthopaedic conditions; smokers. Subjects, who were unable to perform the tests and used medications, which could influence training.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 2617 0
Brazil
State/province [1] 2617 0
Minas Gerais

Funding & Sponsors
Funding source category [1] 256916 0
Government body
Name [1] 256916 0
Conselho Nacional de Desenvolvimento Cientifico e Tecnologico - CNPq
Country [1] 256916 0
Brazil
Funding source category [2] 256917 0
Government body
Name [2] 256917 0
Research Foundation of Minas Gerais - FAPEMIG
Country [2] 256917 0
Brazil
Primary sponsor type
Other
Name
Laboratory of Assesment and Research on Cardiorespiratory Performance
Address
Av. Antonio Carlos, 6627
Pampulha - Belo Horizonte - MG
Departamento de Fisioterapia
CEP 31270-901
Country
Brazil
Secondary sponsor category [1] 256186 0
Individual
Name [1] 256186 0
Raquel Rodrigues Britto
Address [1] 256186 0
Rua Biagio Polizi, 176/301
Bairro Silveira - Belo Horizonte -
MG - 31140-500
Brasil
Country [1] 256186 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258923 0
Ethics Commitee of Federal University of Minas Gerais
Ethics committee address [1] 258923 0
Avenida Antonio Carlos, 6627
Unidade Administrativa II
sala 2005
Pampulha - Belo Horizonte - MG
CEP 31270-901
Ethics committee country [1] 258923 0
Brazil
Date submitted for ethics approval [1] 258923 0
Approval date [1] 258923 0
16/06/2005
Ethics approval number [1] 258923 0
CAAE - 0040.0.203.000-05

Summary
Brief summary
This study were first aproved as a case study and considering the results it was improved as a randomized control trial. Stroke survivors with maximal inspiratory pressure (MIP) lower than 90% of the predicted values, randomly allocated in the control and treatment groups.
Intervention: The intervention is based on Threshold training, bi-weekly adjusted to 30% of the MIP. The control group with the same protocol, without the threshold resistance valve. Both groups receive home training 30 minutes daily, five times/week, during eight weeks.
To study the hypothesis that the treatment will improve MIP, inspiratory muscular endurance (IME), quality of life, and functional performance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31127 0
Address 31127 0
Country 31127 0
Phone 31127 0
Fax 31127 0
Email 31127 0
Contact person for public queries
Name 14374 0
Raquel Rodrigues Britto
Address 14374 0
Rua Biagio Polizi, 176/ 301. Silveira. Belo Horizonte - Minas Gerais - 31.140-500 - Brasil
Country 14374 0
Brazil
Phone 14374 0
55 31 99704527
Fax 14374 0
55 31 34094783
Email 14374 0
rbrito@ufmg.br
Contact person for scientific queries
Name 5302 0
Raquel Rodrigues Britto
Address 5302 0
Rua Biagio Polizi, 176/ 301. Silveira. Belo Horizonte - Minas Gerais - 31.140-500 - Brasil
Country 5302 0
Brazil
Phone 5302 0
55 31 99704527
Fax 5302 0
55 31 34094783
Email 5302 0
rbrito@ufmg.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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