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

NCT ID: NCT05549141

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-20
• Study Completion Date: 2023-10-20

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A 1

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

Group Type: EXPERIMENTAL

treadmill gait training with gait facilitators

Intervention Type: OTHER

6 sessions of 30 minutes each of treadmill gait training with functional electrical stimulation as a gait facilitator

Group B1

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

Group Type: ACTIVE_COMPARATOR

treadmill gait training not-associated with gait facilitators

Intervention Type: OTHER

6 sessions of 30 minutes each of treadmill gait training

Group A2

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

Group Type: ACTIVE_COMPARATOR

treadmill gait training not-associated with gait facilitators

Intervention Type: OTHER

6 sessions of 30 minutes each of treadmill gait training

Group B2

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

Group Type: EXPERIMENTAL

treadmill gait training with gait facilitators

Intervention Type: OTHER

6 sessions of 30 minutes each of treadmill gait training with functional electrical stimulation as a gait facilitator

Interventions

treadmill gait training with gait facilitators

6 sessions of 30 minutes each of treadmill gait training with functional electrical stimulation as a gait facilitator

Intervention Type: OTHER

treadmill gait training not-associated with gait facilitators

6 sessions of 30 minutes each of treadmill gait training

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: collaborator

Universidade do Oeste Paulista

OTHER

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Talita Dias da Silva

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Tereza Dantas

Role: STUDY_DIRECTOR

Universidade do Oeste Paulista

Talita da Silva

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Rodrigo Dias

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

Comitê de Etica da Universidade do Oeste Paulista

Presidente Prudente, São Paulo, Brazil

Site Status: RECRUITING

Comitê de Etica da Universidade Federal de São Paulo

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Talita da Silva, Dr

Role: CONTACT

ft.talitadias@gmail.com

+55 11 99859-0188

Maria Dantas, Dr

Role: CONTACT

mariatereza@unoeste.br

+55 18 99772-3787

Facility Contacts

Maria Dantas, Dr

Role: primary

mariatereza@unoeste.br

(18) 3229-1000

Miguel Jorge

Role: primary

cep@unifesp.br

+55(11)55711062

References

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.

Reference Type: BACKGROUND

PMID: 25685596 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12091180 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8598068 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14716599 (View on PubMed)

Related Links

http://www.visualization-2002.org/VRA_MAIN_PAGE_.html

VISUAL RECURRENCE ANALYSIS.

Other Identifiers

54747521.9.3001.5505

Identifier Type: -

Identifier Source: org_study_id