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

September 26, 2022 updated by: Talita Dias da Silva, University of Sao Paulo

Cardiovascular and Metabolic Effects of Treadmill Gait Training Associated With Functional Electrical Stimulation in Individuals Post-brain Vascular Accident

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 04.023-900
        • Recruiting
        • Comitê de Etica da Universidade Federal de São Paulo
        • Contact:
    • São Paulo
      • Presidente Prudente, São Paulo, Brazil, 19050-680
        • Recruiting
        • Comitê de Etica da Universidade do Oeste Paulista
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A 1
Treadmill gait training using an electrical stimulator, as first intervention.
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
Active Comparator: Group B1
Treadmill gait training without the use of an electrical stimulator, as second intervention.
Other: treadmill gait training not-associated with gait facilitators
6 sessions of 30 minutes each of treadmill gait training
Active Comparator: Group A2
Treadmill gait training without the use of an electrical stimulator, as first intervention.
Other: treadmill gait training not-associated with gait facilitators
6 sessions of 30 minutes each of treadmill gait training
Experimental: Group B2
Treadmill gait training using an electrical stimulator, as second intervention.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability
Time Frame: Twelve weeks
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.
Twelve weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure (Systolic, Diastolic and mean)
Time Frame: Twelve weeks
blood pressure will be assessed using a Bic® aneroid sphygmomanometer and 3M Littmann Classic II stethoscope (New York, USA)
Twelve weeks
Heart rate
Time Frame: Twelve weeks
Heart rate will be analyzed from data collected by Polar S810i (Electro, Kempele, Finland)
Twelve weeks
Double-Product
Time Frame: Twelve weeks
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}
Twelve weeks
Physical fitness (VO2max)
Time Frame: Twelve weeks
VO2max will be estimated from data provided during the 6-minute walk test and calculated according to ACSM guidelines
Twelve weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Federal University of São Paulo
Universidade do Oeste Paulista

Investigators

  • Study Director: Maria Tereza Dantas, Universidade do Oeste Paulista
  • Principal Investigator: Talita da Silva, Federal University of São Paulo
  • Study Chair: Rodrigo Dias, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2022

Primary Completion (Anticipated)

December 15, 2022

Study Completion (Anticipated)

October 20, 2023

Study Registration Dates

First Submitted

August 31, 2022

First Submitted That Met QC Criteria

September 17, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 54747521.9.3001.5505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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