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Cardiovascular Effects of Treadmill Training With Post-stroke Functional Electrical Stimulation

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
treadmill gait training with gait facilitators
treadmill gait training not-associated with gait facilitators
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Exercise, Electric Stimulation, Heart Disease Risk Factors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stroke sequel with motor conditions for training
  • authorization of individuals with the proper signature of the free and informed consent form.

Exclusion Criteria:

  • individuals who have peripheral nerve damage in the lower limbs
  • osteoarticular deformities
  • cognitive impairment
  • visual deficits

Sites / Locations

  • Comitê de Etica da Universidade do Oeste PaulistaRecruiting
  • Comitê de Etica da Universidade Federal de São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Experimental

Arm Label

Group A 1

Group B1

Group A2

Group B2

Arm Description

Treadmill gait training using an electrical stimulator, as first intervention.

Treadmill gait training without the use of an electrical stimulator, as second intervention.

Treadmill gait training without the use of an electrical stimulator, as first intervention.

Treadmill gait training using an electrical stimulator, as second intervention.

Outcomes

Primary Outcome Measures

Heart rate variability
For the analysis of Heart Rate Variability, the heart rate recordings during the period of greatest signal stability will be used, and data from the Polar S810i heart rate monitor (Electro, Kempele, Finland) will be extracted.

Secondary Outcome Measures

Blood Pressure (Systolic, Diastolic and mean)
blood pressure will be assessed using a Bic® aneroid sphygmomanometer and 3M Littmann Classic II stethoscope (New York, USA)
Heart rate
Heart rate will be analyzed from data collected by Polar S810i (Electro, Kempele, Finland)
Double-Product
The double product will be calculated from the product resulting from Systolic Blood Pressure and Heart Rate. {VO2max=[0.02 .distance(m)]-[0.191 .age(years)]-[0.07 .weight(Kg)+[0.09 .height(cm)]+[0.26 .SD( 10^(-3))]+2.45}
Physical fitness (VO2max)
VO2max will be estimated from data provided during the 6-minute walk test and calculated according to ACSM guidelines

Full Information

First Posted
August 31, 2022
Last Updated
September 26, 2022
Sponsor
University of Sao Paulo
Collaborators
Federal University of São Paulo, Universidade do Oeste Paulista
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1. Study Identification

Unique Protocol Identification Number
NCT05549141
Brief Title
Cardiovascular Effects of Treadmill Training With Post-stroke Functional Electrical Stimulation
Official Title
Cardiovascular and Metabolic Effects of Treadmill Gait Training Associated With Functional Electrical Stimulation in Individuals Post-brain Vascular Accident
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Federal University of São Paulo, Universidade do Oeste Paulista

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Ethical parameters: This study will be an analysis based on archived data (under the responsibility of researcher Drª Maria Tereza A. P. Dantas) of the project "Functional electrical stimulation during gait training in people after stroke" approved by the research ethics committee with CAAE number: 52079115.4.0000.5515. Such analyzes have not been performed previously and these will enable the discussion of other important points for the scientific community and health professionals. Type, location and study population: A longitudinal study of an experimental character, in which 26 adults and elderly with hemiparesis by stroke, of both sexes, who attended rehabilitation centers in Presidente Prudente/SP, participated. For the research, individuals were divided into Group A and Group B, randomized, matched by sex, age and according to the side of the body affected by the stroke. Research design: Two treadmill gait training protocols were performed, which differ in the order of use of electrical stimulation in the groups. Each protocol will consist of two training phases, consisting of 6 sessions each, twice a week for 30 minutes. Subjects were assessed before starting the study (Initial Assessment), between phases (Intermediate Assessment) and at the end (Final Assessment). To determine the speed/intensity to be programmed on the treadmill for the sessions, the value of the time required to perform the 10-meter test and the formula: speed equal to the ratio of meters divided by seconds were used, with 40% of this result being selected for speed programming. In order to establish a safety margin in training, risk stratification and training heart rate were used, making it possible to designate minimum and maximum limits. Before and after training, participants rested (10 minutes) to collect cardiorespiratory parameters and HRV. During training, heart rate was monitored to prevent it from exceeding the maximum value, Modified Borg Scale (checks subjective sensation of effort) and HRV. HRV analysis: For HRV analysis, 1000 consecutive RR intervals of the most stable segment of the tachogram will be performed. Only series with an error of less than 5% will be considered suitable for analysis. Data were filtered using Polar Precision Performance software (Polar Electro, Finland) in moderate mode, followed by a visual inspection. HRV will be analyzed by linear methods (time and frequency domains and quantitative analysis of the Poincaré Plot) using the software Kubios® (v. 2.2, Kuopio, Finland). The non-linear HRV characteristics will be calculated through the Poincaré graph, Detrended Fluctuation Analysis (DFA), Recurrence Graph (RP) and Symbolic Analysis (SA). The DFA exponents α1 and α2 will be considered using the software. The recurrence plot will be studied using Visual Recurrence Analysis software (v.4.9) and the configured parameters will be dimension = 10, delay = 1, radio = 70 and line = 2. Data analysis: The data will be analyzed and if the assumptions of normality are not violated, the intergroup and intragroup data will be analyzed using analysis of variance (ANOVA) for repeated measures, Tukey's posthoc will be used and to identify differences, if any. In case of violation of normality assumptions, non-parametric tests such as Mann-Whitney and Kruskal-Wallis will be used. A significance level of p<0.05 will be considered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Exercise, Electric Stimulation, Heart Disease Risk Factors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A 1
Arm Type
Experimental
Arm Description
Treadmill gait training using an electrical stimulator, as first intervention.
Arm Title
Group B1
Arm Type
Active Comparator
Arm Description
Treadmill gait training without the use of an electrical stimulator, as second intervention.
Arm Title
Group A2
Arm Type
Active Comparator
Arm Description
Treadmill gait training without the use of an electrical stimulator, as first intervention.
Arm Title
Group B2
Arm Type
Experimental
Arm Description
Treadmill gait training using an electrical stimulator, as second intervention.
Intervention Type
Other
Intervention Name(s)
treadmill gait training with gait facilitators
Intervention Description
6 sessions of 30 minutes each of treadmill gait training with functional electrical stimulation as a gait facilitator
Intervention Type
Other
Intervention Name(s)
treadmill gait training not-associated with gait facilitators
Intervention Description
6 sessions of 30 minutes each of treadmill gait training
Primary Outcome Measure Information:
Title
Heart rate variability
Description
For the analysis of Heart Rate Variability, the heart rate recordings during the period of greatest signal stability will be used, and data from the Polar S810i heart rate monitor (Electro, Kempele, Finland) will be extracted.
Time Frame
Twelve weeks
Secondary Outcome Measure Information:
Title
Blood Pressure (Systolic, Diastolic and mean)
Description
blood pressure will be assessed using a Bic® aneroid sphygmomanometer and 3M Littmann Classic II stethoscope (New York, USA)
Time Frame
Twelve weeks
Title
Heart rate
Description
Heart rate will be analyzed from data collected by Polar S810i (Electro, Kempele, Finland)
Time Frame
Twelve weeks
Title
Double-Product
Description
The double product will be calculated from the product resulting from Systolic Blood Pressure and Heart Rate. {VO2max=[0.02 .distance(m)]-[0.191 .age(years)]-[0.07 .weight(Kg)+[0.09 .height(cm)]+[0.26 .SD( 10^(-3))]+2.45}
Time Frame
Twelve weeks
Title
Physical fitness (VO2max)
Description
VO2max will be estimated from data provided during the 6-minute walk test and calculated according to ACSM guidelines
Time Frame
Twelve weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stroke sequel with motor conditions for training authorization of individuals with the proper signature of the free and informed consent form. Exclusion Criteria: individuals who have peripheral nerve damage in the lower limbs osteoarticular deformities cognitive impairment visual deficits
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Talita da Silva, Dr
Phone
+55 11 99859-0188
Email
ft.talitadias@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Dantas, Dr
Phone
+55 18 99772-3787
Email
mariatereza@unoeste.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Tereza Dantas
Organizational Affiliation
Universidade do Oeste Paulista
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Talita da Silva
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rodrigo Dias
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Comitê de Etica da Universidade do Oeste Paulista
City
Presidente Prudente
State/Province
São Paulo
ZIP/Postal Code
19050-680
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Dantas, Dr
Phone
(18) 3229-1000
Email
mariatereza@unoeste.br
Facility Name
Comitê de Etica da Universidade Federal de São Paulo
City
São Paulo
ZIP/Postal Code
04.023-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Jorge
Phone
+55(11)55711062
Email
cep@unifesp.br

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25685596
Citation
Dunn A, Marsden DL, Nugent E, Van Vliet P, Spratt NJ, Attia J, Callister R. Protocol variations and six-minute walk test performance in stroke survivors: a systematic review with meta-analysis. Stroke Res Treat. 2015;2015:484813. doi: 10.1155/2015/484813. Epub 2015 Jan 20.
Results Reference
background
PubMed Identifier
12091180
Citation
ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
Results Reference
background
PubMed Identifier
8598068
Citation
Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
Results Reference
background
PubMed Identifier
14716599
Citation
Huikuri HV, Makikallio TH, Perkiomaki J. Measurement of heart rate variability by methods based on nonlinear dynamics. J Electrocardiol. 2003;36 Suppl:95-9. doi: 10.1016/j.jelectrocard.2003.09.021.
Results Reference
background
Links:
URL
http://www.visualization-2002.org/VRA_MAIN_PAGE_.html
Description
VISUAL RECURRENCE ANALYSIS.
URL
http://www.danielpenteado.com/home
Description
CardioSeries

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Cardiovascular Effects of Treadmill Training With Post-stroke Functional Electrical Stimulation

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