Cardiovascular Effects of Treadmill Training With Post-stroke Functional Electrical Stimulation
NCT05549141 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2022-09-29
Summary
Introduction: Stroke is one of the major causes of morbidity/mortality in the world and affected individuals, due to important (mainly motor) impairments, have their physical capacity to exercise reduced, a fact that aggravates the cardiovascular risk factors already installed. For this reason, a cardiovascular rehabilitation program, in addition to motor rehabilitation, must be added to the life of this individual. Objective: To verify the cardiovascular and metabolic effects of treadmill gait training associated with functional electrical stimulation in individuals after stroke. Method: This study will be an analysis based on archived data from the project "Functional electrical stimulation during gait training in people after stroke" approved by the CEP with CAAE number: 52079115.4.0000.5515. Such analyzes have not been carried out before and they will enable the discussion of other important points for the scientific community and health professionals. The study included 20 adults (aged between 45 and 59 years) and elderly individuals (aged between 60 and 70 years) with sequelae of hemiparesis due to stroke, of both sexes. To assess functional capacity, the 6-minute walk test was performed and, from this, the Double product, VO2max and metabolic consumption units (METs) will be estimated in this research. There were two protocols (Group A and B) formed by two training phases alternating between moments with and without electrical stimulation (WalkAide), consisting of 12 sessions, twice a week and lasting 30 minutes. In each session before and after training, the participants remained seated at rest for 10 minutes, for the collection of cardiorespiratory parameters and heart rate variability. During training on a treadmill with or without electrical stimulation, heart rate and heart rate variability (HRV) were monitored, and a detailed analysis of HRV will be carried out in this research. Data will be analyzed and statistically treated, considering a significance level of p\<0.05.
Conditions
Interventions
- OTHER
-
treadmill gait training with gait facilitators
6 sessions of 30 minutes each of treadmill gait training with functional electrical stimulation as a gait facilitator
- OTHER
-
treadmill gait training not-associated with gait facilitators
6 sessions of 30 minutes each of treadmill gait training
Sponsors & Collaborators
-
Federal University of São Paulo
collaborator OTHER -
Universidade do Oeste Paulista
collaborator OTHER -
University of Sao Paulo
lead OTHER
Principal Investigators
-
Maria Tereza Dantas · Universidade do Oeste Paulista
-
Talita da Silva · Federal University of São Paulo
-
Rodrigo Dias · Federal University of São Paulo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-20
- Primary Completion
- 2022-12-15
- Completion
- 2023-10-20
Countries
- Brazil
Study Locations
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