Effects of Inspiratory Muscle Training on the Functional Gait Performance of Individuals After Stroke
Condition: Stroke; Inspiratory Muscle Training; Quality of Life; Gait
MeSH terms: Respiratory Aspiration; Stroke
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Inspiratory Muscle Training
Intervention type(s): Other
Intervention description(s): Experimental: IMT will include training of the inspiratory muscles five times per week over six weeks, divided into two fiftten-minute sessions of inspiratory training totaling 30 minutes of training. Thresholds regulated at 50% of the subjects' maximal inspiratory pressure values, the load being increased weekly. Associated with the IMT, subjects will participate in the rehabilitation program, when they will perform 7 sessions of physiotherapy per week, totaling 42 sessions, as well as 180 minutes per week of aerobic exercise, for six weeks.
Sham Group: This group will underwent exactly the same protocol but the participants will receive the threshold devices with the minimum resistance of the spring, which will be also concealed. The control group will also participate in the rehabilitation program and undergo the same procedures, except for the load adjustments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment