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

No results posted yet for this study

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05549141 on ClinicalTrials.gov