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

NCT05549141 | Unknown

• 1 other identifier: 54747521.9.3001.5505
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

Stroke; Exercise; Electric Stimulation; Heart Disease Risk Factors

Outcome Measures

Primary Outcomes (1)

• 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.

  Twelve weeks

Secondary Outcomes (4)

• Blood Pressure (Systolic, Diastolic and mean)

  Twelve weeks

• Heart rate

  Twelve weeks

• Double-Product

  Twelve weeks

• Physical fitness (VO2max)

  Twelve weeks

Study Arms (4)

Group A 1

EXPERIMENTAL

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

Other: treadmill gait training with gait facilitators

Group B1

ACTIVE COMPARATOR

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

Other: treadmill gait training not-associated with gait facilitators

Group A2

ACTIVE COMPARATOR

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

Other: treadmill gait training not-associated with gait facilitators

Group B2

EXPERIMENTAL

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

Other: treadmill gait training with gait facilitators

Interventions

treadmill gait training with gait facilitators OTHER

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

Group A 1; Group B2

treadmill gait training not-associated with gait facilitators OTHER

6 sessions of 30 minutes each of treadmill gait training

Group A2; Group B1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Federal University of São Paulo: collaborator
• Universidade do Oeste Paulista: collaborator

Study Sites (2)

Comitê de Etica da Universidade do Oeste Paulista

Presidente Prudente, São Paulo, 19050-680, Brazil

RECRUITING

Comitê de Etica da Universidade Federal de São Paulo

São Paulo, 04.023-900, Brazil

RECRUITING

Related Publications (4)

• 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.

  PMID: 25685596 BACKGROUND

• 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.

  PMID: 12091180 BACKGROUND

• 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.

  PMID: 8598068 BACKGROUND

• 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.

  PMID: 14716599 BACKGROUND

Related Links

• VISUAL RECURRENCE ANALYSIS.

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Maria Tereza Dantas

  Universidade do Oeste Paulista

  STUDY DIRECTOR

• Talita da Silva

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• Rodrigo Dias

  Federal University of São Paulo

  STUDY CHAIR

Central Study Contacts

Talita da Silva, Dr

CONTACT

+55 11 99859-0188; ft.talitadias@gmail.com

Maria Dantas, Dr

CONTACT

+55 18 99772-3787; mariatereza@unoeste.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 22, 2022
• Study Start: August 20, 2022
• Primary Completion: December 15, 2022
• Study Completion: October 20, 2023
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)