Stroke Clinical Trial
Official title:
Effects of Inspiratory Muscle Training on the Functional Gait Performance of Individuals After Stroke
The most commonly observed sequel after stroke is muscle weakness, which can also be
identified in respiratory muscles, in the acute and chronic phases, and may compromise the
lung function of these individuals. Studies have shown that lower Pimax values are found in
non-community ambulators, and gait velocity has been reported as an important indicator of
functionality after stroke, with higher gait velocity values associated with greater
community participation and better quality of life.
This study will test the hypothesis that training of the inspiratory muscles is effective in
improving strength and endurance of the inspiratory muscles and functionality, including
speed of gait, functional gait perfomarnce, activities of daily living and quality of life
with stroke subjects.
For this clinical trial, people after stroke will be randomly allocated into either
experimental or control/sham groups. The experimental group will undertake training of the
inspiratory muscles with the Power Breath Medical Classic device regulated at 50% of the
subjects' maximal inspiratory pressure values, five times/week over six weeks, twice a day
for 15 minutes, totaling 30 minutes/day. The control group will undertake the same protocol,
but the participants will receive the devices with a minimal load, wich corresponds to
1cmH2O. Both groups will participate in the rehabilitation program for 6 weeks. At baseline
and post intervention, after the cessation of the interventions, researchers blinded to group
allocations will collect the following outcome measures: maximal respiratory pressures,
respiratory muscle endurance, functional gait performance, activities of daily living and
quality of life. After 12 weeks will collect again maximal inspiratory pressures and
functional gait performance.
The most commonly observed sequel after stroke is muscle weakness, which can also be
identified in respiratory muscles, in the acute and chronic phases, and may compromise the
lung function of these individuals. Studies have shown that lower Pimax values are found in
non-community ambulators, and gait velocity has been reported as an important indicator of
functionality after stroke, with higher gait velocity values associated with greater
community participation and better Quality of life.
Aim: This study will test the hypothesis that training of the inspiratory muscles is
effective in improving strength and endurance of the inspiratory muscles and functional gait
perfomarnce, activities of daily living and quality of life with stroke subjects.
Design: For this prospective, triple-blinded, randomized clinical trial, people after stroke
will be randomly allocated into either experimental or control/sham groups. The experimental
group will undertake training of the inspiratory muscles with the PowerBreath Medic Plus
regulated at 50% of the subjects' maximal inspiratory pressure (MIP) values, five times/week
over six weeks during 30 minutes/day. The control group will undertake the same protocol, but
the participants will receive the threshold devices with minimal resistance valves. At
baseline and post intervention after the cessation of the interventions, researchers blinded
to group allocations will collect all outcome measures. After 12 weeks will collect again
maximal inspiratory pressures and functional gait performance.
Study outcomes: Primary outcomes will be functional gait perfomarnce. Secondary outcomes will
include inspiratory endurance, activities of daily living and quality of life.
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