StrokeNCT05549141
Cardiovascular Effects of Treadmill Training With Post-stroke Functional Electrical Stimulation
A study testing treadmill gait training with gait facilitators and treadmill gait training not-associated with gait facilitators in people with Stroke, run by University of Sao Paulo at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- treadmill gait training with gait facilitators and treadmill gait training not-associated with gait facilitators
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesBrazil
- Study dates
- 20 Aug 2022to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke sequel with motor conditions for training
- authorization of individuals with the proper signature of the free and informed consent form.
Who cannot join
- individuals who have peripheral nerve damage in the lower limbs
- osteoarticular deformities
- cognitive impairment
- visual deficits
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Comitê de Etica da Universidade do Oeste Paulista
Presidente Prudente, São Paulo, 19050-680
Maria Dantas, Dr, (18) 3229-1000, mariatereza@unoeste.br
- Recruiting
Comitê de Etica da Universidade Federal de São Paulo
São Paulo, 04.023-900
Miguel Jorge, +55(11)55711062, cep@unifesp.br
About this study
Official title: 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.
Read the 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
- Being tested
- treadmill gait training with gait facilitators, treadmill gait training not-associated with gait facilitators
- Keywords
- Stroke, Exercise, Electric Stimulation, Heart Disease Risk Factors
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treadmill gait training with gait facilitatorsOther
6 sessions of 30 minutes each of treadmill gait training with functional electrical stimulation as a gait facilitator
treadmill gait training not-associated with gait facilitatorsOther
6 sessions of 30 minutes each of treadmill gait training
| Study group | Role | What they receive |
|---|---|---|
| Group A 1 | Experimental | Treadmill gait training using an electrical stimulator, as first intervention. Receives: Other: treadmill gait training with gait facilitators |
| Group B1 | Active comparator | Treadmill gait training without the use of an electrical stimulator, as second intervention. Receives: 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. Receives: Other: treadmill gait training not-associated with gait facilitators |
| Group B2 | Experimental | Treadmill gait training using an electrical stimulator, as second intervention. Receives: Other: treadmill gait training with gait facilitators |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Twelve weeks
Secondary outcomes (4)
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)
Measured: Twelve weeks
Heart rate
Heart rate will be analyzed from data collected by Polar S810i (Electro, Kempele, Finland)
Measured: Twelve weeks
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}
Measured: Twelve weeks
Physical fitness (VO2max)
VO2max will be estimated from data provided during the 6-minute walk test and calculated according to ACSM guidelines
Measured: Twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start20 Aug 2022
- Primary completion15 Dec 2022 (estimated)
- Study completion20 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo, Universidade do Oeste Paulista
- Responsible party
- Principal investigator, Talita Dias da Silva, University of Sao Paulo
- Investigators
- Maria Tereza Dantas, Study director, Universidade do Oeste PaulistaTalita da Silva, Principal investigator, Federal University of São PauloRodrigo Dias, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549141
- Sponsor's protocol ID
- 54747521.9.3001.5505
- Status last verified
- Sep 2022
- First submitted
- 31 Aug 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25685596ATS 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.
PubMed 12091180Heart 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.
PubMed 8598068Huikuri 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.
PubMed 14716599
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular and Metabolic Effects of Treadmill Gait Training Associated With Functional Electrical Stimulation in Individuals Post-brain Vascular Accident
- ClinicalTrials.gov ID
- NCT05549141
- Acronym / sponsor ID
- 54747521.9.3001.5505
- Conditions
- Stroke
- Keywords
- Stroke, Exercise, Electric Stimulation, Heart Disease Risk Factors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Federal University of São Paulo, Universidade do Oeste Paulista
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 20 Oct 2023 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A 1 | Experimental | Other: treadmill gait training with gait facilitatorsTreadmill gait training using an electrical stimulator, as first intervention. |
| Group B1 | Active comparator | Other: treadmill gait training not-associated with gait facilitatorsTreadmill gait training without the use of an electrical stimulator, as second intervention. |
| Group A2 | Active comparator | Other: treadmill gait training not-associated with gait facilitatorsTreadmill gait training without the use of an electrical stimulator, as first intervention. |
| Group B2 | Experimental | Other: treadmill gait training with gait facilitatorsTreadmill gait training using an electrical stimulator, as second intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stroke sequel with motor conditions for training
- authorization of individuals with the proper signature of the free and informed consent form.
Key exclusion criteria (4 listed)
- individuals who have peripheral nerve damage in the lower limbs
- osteoarticular deformities
- cognitive impairment
- visual deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treadmill gait training with gait facilitators6 sessions of 30 minutes each of treadmill gait training with functional electrical stimulation as a gait facilitator | Other | Group A 1, Group B2 |
| treadmill gait training not-associated with gait facilitators6 sessions of 30 minutes each of treadmill gait training | Other | Group A2, Group B1 |
Primary outcome
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.
4 secondary outcomes
Blood Pressure (Systolic, Diastolic and mean)
Time frame: Twelve weeks
Heart rate
Time frame: Twelve weeks
Double-Product
Time frame: Twelve weeks
Physical fitness (VO2max)
Time frame: Twelve weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Background: PubMed 25685596Dunn 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.
- Background: PubMed 12091180ATS 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.
- Background: PubMed 8598068Heart 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.
- Background: PubMed 14716599Huikuri 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.
- VISUAL RECURRENCE ANALYSIS.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Tereza Dantas study director
Universidade do Oeste Paulista
Talita da Silva principal investigator
Federal University of São Paulo
Rodrigo Dias study chair
Federal University of São Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treadmill gait training with gait facilitators and treadmill gait training not-associated with gait facilitators in people with Stroke, run by University of Sao Paulo at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Talita da Silva, Dr (+55 11 99859-0188, ft.talitadias@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: Twelve weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05549141, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.