Home-based Respiratory Training After Stroke

Completed

Phase N/A Results N/A

Update History

2 Aug '17
The Summary of Purpose was updated.
New
Weakness of the respiratory muscles demonstrated by individuals with stroke, may generate important symptoms, such as fatigue and dyspnea. Since adequate strength of the inspiratory and expiratory muscles is required, mainly when performing physical activities, rehabilitation interventions for stroke subjects should include respiratory training. This study will test the hypothesis that home-based combined training of the inspiratory and expiratory muscles is effective in improving strength and endurance of the inspiratory and expiratory muscles, fatigue, exercise capacity, 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 plus expiratory muscles with the Threshold device regulated at 40% of the subjects' maximal inspiratory and expíratory pressure values, five times/week over eight weeks during 30 minutes/day. The control group will undertake the same protocol, but the participants will receive the threshold devices without the resistance valves. At baseline, post intervention, and four and 12 weeks after the cessation of the interventions, researchers blinded to group allocations will collect the following outcome measures: maximal inspiratory and expiratory pressures, endurance, fatigue, dyspnea sensation, exercise capacity, and quality of life.
Old
Weakness of the respiratory muscles demonstrated by individuals with stroke, may generate important symptoms, such as fatigue and dyspnea. Since adequate strength of the inspiratory and expiratory muscles is required, mainly when performing physical activities, rehabilitation interventions for stroke subjects should include respiratory training. This study will test the hypothesis that home-based combined training of the inspiratory and expiratory muscles is effective in improving strength and endurance of the inspiratory and expiratory muscles, fatigue, exercise capacity, 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 plus expiratory muscles with the Threshold device regulated at 40% of the subjects' maximal inspiratory and expíratory pressure values, five times/week over eight weeks during 30 minutes/day. The control group will undertake the same protocol, but the participants will receive the threshold devices without the resistance valves. At baseline, post intervention, and four and 12 weeks after the cessation of the interventions, researchers blinded to group allocations will collect the following outcome measures: maximal inspiratory and expiratory pressures, endurance, fatigue, dyspnea sensation, exercise capacity, and quality of life.
The description was updated.
New
Rationale: Weakness of the respiratory muscles demonstrated by individuals with stroke, may generate important symptoms, such as fatigue and dyspnea. Since adequate strength of the inspiratory and expiratory muscles is required, mainly when performing physical activities, rehabilitation interventions for stroke subjects should include respiratory training. Aim: This study will test the hypothesis that home-based combined inspiratory muscular training (IMT) plus expiratory muscular training (EMT) program is effective in improving strength and endurance of the inspiratory and expiratory muscles, fatigue, exercise capacity, and quality of life (QoL) with stroke subjects. Design: For this prospective, double-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 plus expiratory muscles with the Threshold® IMT and the Threshold™ PEP regulated at 40% of the subjects' maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values, five times/week over eight weeks during 30 minutes/day. The control group will undertake the same protocol, but the participants will receive the threshold devices without the resistance valves. At baseline, post intervention, and four and 12 weeks after the cessation (two follow-ups) of the interventions, researchers blinded to group allocations will collect all outcome measures. Study outcomes: Primary outcomes will be MIP and MEP. Secondary outcomes will include inspiratory and expiratory endurance, fatigue, dyspnea sensation, exercise capacity, and QoL.
Old
Rationale: Weakness of the respiratory muscles demonstrated by individuals with stroke, may generate important symptoms, such as fatigue and dyspnea. Since adequate strength of the inspiratory and expiratory muscles is required, mainly when performing physical activities, rehabilitation interventions for stroke subjects should include respiratory training. Aim: This study will test the hypothesis that home-based combined inspiratory muscular training (IMT) plus expiratory muscular training (EMT) program is effective in improving strength and endurance of the inspiratory and expiratory muscles, fatigue, exercise capacity, and quality of life (QoL) with stroke subjects. Design: For this prospective, double-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 plus expiratory muscles with the Threshold® IMT and the Threshold™ PEP regulated at 40% of the subjects' maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values, five times/week over eight weeks during 30 minutes/day. The control group will undertake the same protocol, but the participants will receive the threshold devices without the resistance valves. At baseline, post intervention, and four and 12 weeks after the cessation (two follow-ups) of the interventions, researchers blinded to group allocations will collect all outcome measures. Study outcomes: Primary outcomes will be MIP and MEP. Secondary outcomes will include inspiratory and expiratory endurance, fatigue, dyspnea sensation, exercise capacity, and QoL.
Trial was updated to "N/A."
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
Inclusion Criteria: Stroke survivors will be eligible if they: are older than 20 years of age; have a mean time since of the onset of a unilateral stroke of at least three months; show no cognitive impairments, identified by the education adjusted cut-off scores on the Mini-Mental State Examination (MMSE)(16); have MIP and MEP values lower than 70% of the predicted ones for the healthy population(17); have no facial palsy, that could prevent proper labial occlusion; be able to use a cycle ergometer; have no restriction in lung function and no other neurologic, orthopedic or unstable cardiac conditions, that could prevent the tests and training; were non-smokers or smoke-free for at least five years; and have not undergone thoracic or abdominal surgery. Exclusion Criteria: Subjects will be excluded if they are already performing any type of respiratory training.
Old
Inclusion Criteria: Stroke survivors will be eligible if they: are older than 20 years of age; have a mean time since of the onset of a unilateral stroke of at least three months; show no cognitive impairments, identified by the education adjusted cut-off scores on the Mini-Mental State Examination (MMSE)(16); have MIP and MEP values lower than 70% of the predicted ones for the healthy population(17); have no facial palsy, that could prevent proper labial occlusion; be able to use a cycle ergometer; have no restriction in lung function and no other neurologic, orthopedic or unstable cardiac conditions, that could prevent the tests and training; were non-smokers or smoke-free for at least five years; and have not undergone thoracic or abdominal surgery. Exclusion Criteria: Subjects will be excluded if they are already performing any type of respiratory training.
A location was updated in Belo Horizonte.
New
The overall status was removed for Department of Physical Therapy, Universidade Federal de Minas Gerais.
A location was updated in Belo Horizonte.
New
The overall status was removed for NeuroGroup Laboratory.
4 Feb '16
The Summary of Purpose was updated.
New
Weakness of the respiratory muscles demonstrated by individuals with stroke, may generate important symptoms, such as fatigue and dyspnea. Since adequate strength of the inspiratory and expiratory muscles is required, mainly when performing physical activities, rehabilitation interventions for stroke subjects should include respiratory training. This study will test the hypothesis that home-based combined training of the inspiratory and expiratory muscles is effective in improving strength and endurance of the inspiratory and expiratory muscles, fatigue, exercise capacity, 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 plus expiratory muscles with the Threshold device regulated at 40% of the subjects' maximal inspiratory and expíratory pressure values, five times/week over eight weeks during 30 minutes/day. The control group will undertake the same protocol, but the participants will receive the threshold devices without the resistance valves. At baseline, post intervention, and four and 12 weeks after the cessation of the interventions, researchers blinded to group allocations will collect the following outcome measures: maximal inspiratory and expiratory pressures, endurance, fatigue, dyspnea sensation, exercise capacity, and quality of life.
Old
Weakness of the respiratory muscles demonstrated by individuals with stroke, may generate important symptoms, such as fatigue and dyspnea. Since adequate strength of the inspiratory and expiratory muscles is required, mainly when performing physical activities, rehabilitation interventions for stroke subjects should include respiratory training. This study will test the hypothesis that home-based combined training of the inspiratory and expiratory muscles is effective in improving strength and endurance of the inspiratory and expiratory muscles, fatigue, exercise capacity, 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 plus expiratory muscles with the Threshold device regulated at 40% of the subjects' maximal inspiratory and exíratory pressure values, five times/week over eight weeks during 30 minutes/day. The control group will undertake the same protocol, but the participants will receive the threshold devices without the resistance valves. At baseline, post intervention, and four and 12 weeks after the cessation of the interventions, researchers blinded to group allocations will collect the following outcome measures: maximal inspiratory and expiratory pressures, endurance, fatigue, dyspnea sensation, exercise capacity, and quality of life.
A location was updated in Belo Horizonte.
New
The overall status was removed for Department of Physical Therapy, Universidade Federal de Minas Gerais.