Dataset Information

Effects of inclined treadmill training on functional and cardiovascular parameters of stroke patients: study protocol for a randomized controlled trial.

ABSTRACT:

Background

Treadmill training has been widely used for gait recovery after stroke. Gait re-establishment is one of the main objectives of rehabilitation programs after stroke, aiming to acquire more functional patterns and increase walking speed, along with improvement in cardiovascular function. The aim of this study is to evaluate the effects of a treadmill gait training protocol on functional and cardiovascular variables in patients with chronic stroke.

Methods

A single-blind randomized clinical trial will be conducted. The sample will consist of 36 patients, who will be allocated in three groups: control group (n = 12), experimental group 1 (n = 12), and experimental group 2 (n = 12). The intervention will occur for 6 consecutive weeks, three times a week, 30?min each session, in all groups. The control group will perform a treadmill gait training without inclination, experimental group 1 will perform a treadmill gait training with anterior inclination of 5%, and experimental group 2 will perform a treadmill gait training with anterior inclination of 10%. All participants will be assessed for sample characterization measures, gait speed, functional capacity, systemic arterial blood pressure, heart rate, peripheral oxygen saturation, exercise capacity, neuromuscular torque, and quality of life. Evaluations of outcome measures will occur at the end of the interventions (post-training) and after 1?month and 1?year after the end of the interventions (short- and long-term follow-up). Statistical analysis will be performed descriptively and inferentially. Alpha equals 5% will be considered for inferential analysis. Mixed analysis of variance with repeated measures will be used to compare outcome measures between groups and between baseline, post-training, and follow-up. Normality test (Shapiro-Wilk) and subsequently t test (or Mann-Whitney) will be used to compare groups during the same training session.

Discussion

It is believed that treadmill training, especially treadmill training with anterior inclination, may result in improved exercise capacity in patients with stroke, reduced blood pressure and heart rate values, and an improvement in functional parameters with increased gait speed, functional capacity, quadriceps muscle torque, and quality of life.

Trial registration

Registration in Brazilian Registry of Clinical Trials (ReBEC) identifier RBR-5ffbxz , date of registration October 25 2017.

SUBMITTER: da Silva RS

PROVIDER: S-EPMC6498604 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Publications

Effects of inclined treadmill training on functional and cardiovascular parameters of stroke patients: study protocol for a randomized controlled trial.

da Silva Raiff Simplício RS da Silva Stephano Tomaz ST de Souza Jesimiel Missias JM de Figueiredo Marianna Celeste Cordeiro MCC Mendes Thaís Almeida Silveira TAS de Sena Nunes Maria Clara MC de Oliveira Samara Katiane Rolim SKR Cardoso Daiane Carla Rodrigues DCR da Câmara Silva Raiza Gabriella RG de Oliveira Débora Carvalho DC Ribeiro Tatiana Souza TS

Trials 20190502 1

<h4>Background</h4>Treadmill training has been widely used for gait recovery after stroke. Gait re-establishment is one of the main objectives of rehabilitation programs after stroke, aiming to acquire more functional patterns and increase walking speed, along with improvement in cardiovascular function. The aim of this study is to evaluate the effects of a treadmill gait training protocol on functional and cardiovascular variables in patients with chronic stroke.<h4>Methods</h4>A single-blind r ...[more]

PMID: 31046812

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Project description:The use of functional music in gait training termed rhythmic auditory stimulation (RAS) and treadmill training (TT) have both been shown to be effective in stroke patients (SP). The combination of RAS and treadmill training (RAS-TT) has not been clinically evaluated to date. The aim of the study was to evaluate the efficacy of RAS-TT on functional gait in SP. The protocol followed the design of an explorative study with a rater-blinded three arm prospective randomized controlled parallel group design. Forty-five independently walking SP with a hemiparesis of the lower limb or an unsafe and asymmetrical walking pattern were recruited. RAS-TT was carried out over 4 weeks with TT and neurodevelopmental treatment based on Bobath approach (NDT) serving as control interventions. For RAS-TT functional music was adjusted individually while walking on the treadmill. Pre and post-assessments consisted of the fast gait speed test (FGS), a gait analysis with the locometre (LOC), 3 min walking time test (3MWT), and an instrumental evaluation of balance (IEB). Raters were blinded to group assignments. An analysis of covariance (ANCOVA) was performed with affiliated measures from pre-assessment and time between stroke and start of study as covariates. Thirty-five participants (mean age 63.6 ± 8.6 years, mean time between stroke and start of study 42.1 ± 23.7 days) completed the study (11 RAS-TT, 13 TT, 11 NDT). Significant group differences occurred in the FGS for adjusted post-measures in gait velocity [F (2, 34) = 3.864, p = 0.032; partial ?2 = 0.205] and cadence [F (2, 34) = 7.656, p = 0.002; partial ?2 = 0.338]. Group contrasts showed significantly higher values for RAS-TT. Stride length results did not vary between the groups. LOC, 3MWT, and IEB did not indicate group differences. One patient was withdrawn from TT because of pain in one arm. The study provides first evidence for a higher efficacy of RAS-TT in comparison to the standard approaches TT and NDT in restoring functional gait in SP. The results support the implementation of functional music in neurological gait rehabilitation and its use in combination with treadmill training. Clinical Trial Registration: https://www.drks.de/drks_web/, identifier DRKS00014603.

Project description:After experiencing a stroke, most individuals also suffer from cardiac disease, are immobile and thus have low endurance for exercise. Aerobic capacity is seriously reduced in these individuals and does not reach reasonable levels after conventional rehabilitation programmes. Cardiovascular exercise is beneficial for improvement of aerobic capacity in mild to moderate stroke. However, less is known about its impact on aerobic capacity, motor recovery, and quality-of-life in severely impaired individuals. The aim of this pilot study is to explore the clinical efficacy and feasibility of cardiovascular exercise with regard to aerobic capacity, motor recovery, and quality-of-life using feedback-controlled robotics-assisted treadmill exercise in non-ambulatory individuals soon after experiencing a stroke.This will be a single-centred single blind, randomised control trial with a pre-post intervention design. Subjects will be recruited early after their first stroke (?20 weeks) at a neurological rehabilitation clinic and will be randomly allocated to an inpatient cardiovascular exercise programme that uses feedback-controlled robotics-assisted treadmill exercise (experimental) or to conventional robotics-assisted treadmill exercise (control). Intervention duration depends on the duration of each subject's inpatient rehabilitation period. Aerobic capacity, as the primary outcome measure, will be assessed using feedback-controlled robotics-assisted treadmill-based cardiopulmonary exercise testing. Secondary outcome measures will include gait speed, walking endurance, standing function, and quality-of-life. Outcome assessment will be conducted at baseline, after each 4-week intervention period, and before clinical discharge. Ethical approval has been obtained.Whether cardiovascular exercise in non-ambulatory individuals early after stroke has an impact on aerobic capacity, motor recovery, and quality-of-life is not yet known. Feedback-controlled robotics-assisted treadmill exercise is a relatively recent intervention method and might be used to train and evaluate aerobic capacity in this population. The present pilot trial is expected to provide new insights into the implementation of early cardiovascular exercise for individuals with severe motor impairment. The findings of this study may guide future research to explore the effects of early cardiovascular activation after severe neurological events.This trial is registered with the Clinical Trials.gov Registry (NCT01679600).

Project description:Although task-oriented training has been shown to improve walking outcomes after stroke, it is not yet clear whether one task-oriented approach is superior to another. The purpose of this study is to compare the effectiveness of the Motor Learning Walking Program (MLWP), a varied overground walking task program consistent with key motor learning principles, to body-weight-supported treadmill training (BWSTT) in community-dwelling, ambulatory, adults within 1 year of stroke.A parallel, randomized controlled trial with stratification by baseline gait speed will be conducted. Allocation will be controlled by a central randomization service and participants will be allocated to the two active intervention groups (1:1) using a permuted block randomization process. Seventy participants will be assigned to one of two 15-session training programs. In MLWP, one physiotherapist will supervise practice of various overground walking tasks. Instructions, feedback, and guidance will be provided in a manner that facilitates self-evaluation and problem solving. In BWSTT, training will emphasize repetition of the normal gait cycle while supported over a treadmill, assisted by up to three physiotherapists. Outcomes will be assessed by a blinded assessor at baseline, post-intervention and at 2-month follow-up. The primary outcome will be post-intervention comfortable gait speed. Secondary outcomes include fast gait speed, walking endurance, balance self-efficacy, participation in community mobility, health-related quality of life, and goal attainment. Groups will be compared using analysis of covariance with baseline gait speed strata as the single covariate. Intention-to-treat analysis will be used.In order to direct clinicians, patients, and other health decision-makers, there is a need for a head-to-head comparison of different approaches to active, task-related walking training after stroke. We hypothesize that outcomes will be optimized through the application of a task-related training program that is consistent with key motor learning principles related to practice, guidance and feedback.ClinicalTrials.gov # NCT00561405.

Project description:BACKGROUND:Body weight support treadmill training protocols in conjunction with other modalities are commonly used to improve poststroke balance and walking function. However, typical body weight support paradigms tend to use consistently stable balance conditions, often with handrail support and or manual assistance. OBJECTIVE:In this paper, we describe our study protocol, which involved 2 unique body weight support treadmill training paradigms of similar training intensity that integrated dynamic balance challenges to help improve ambulatory function post stroke. The first paradigm emphasized walking without any handrails or manual assistance, that is, hands-free walking, and served as the control group, whereas the second paradigm incorporated practicing 9 essential challenging mobility skills, akin to environmental barriers encountered during community ambulation along with hands-free walking (ie hands-free + challenge walking). METHODS:We recruited individuals with chronic poststroke hemiparesis and randomized them to either group. Participants trained for 6 weeks on a self-driven, robotic treadmill interface that provided body weight support and a safe gait-training environment. We assessed participants at pre-, mid- and post 6 weeks of intervention-training, with a 6-month follow-up. We hypothesized greater walking improvements in the hands-free + challenge walking group following training because of increased practice opportunity of essential mobility skills along with hands-free walking. RESULTS:We assessed 77 individuals with chronic hemiparesis, and enrolled and randomized 30 individuals poststroke for our study (hands-free group=19 and hands-free + challenge walking group=20) from June 2012 to January 2015. Data collection along with 6-month follow-up continued until January 2016. Our primary outcome measure is change in comfortable walking speed from pre to post intervention for each group. We will also assess feasibility, adherence, postintervention efficacy, and changes in various exploratory secondary outcome measures. Additionally, we will also assess participant responses to a study survey, conducted at the end of training week, to gauge each group's training experiences. CONCLUSIONS:Our treadmill training paradigms, and study protocol represent advances in standardized approaches to selecting body weight support levels without the necessity for using handrails or manual assistance, while progressively providing dynamic challenges for improving poststroke ambulatory function during rehabilitation. TRIAL REGISTRATION:ClinicalTrials.gov NCT02787759; https://clinicaltrials.gov/ct2/show/NCT02787759 (Archived by Webcite at http://www.webcitation.org/6yJZCrIea).

Project description:Cardiovascular fitness is greatly reduced after stroke. Although individuals with mild to moderate impairments benefit from conventional cardiovascular exercise interventions, there is a lack of effective approaches for persons with severely impaired physical function. This randomized controlled pilot trial investigated efficacy and feasibility of feedback-controlled robotics-assisted treadmill exercise (FC-RATE) for cardiovascular rehabilitation in persons with severe impairments early after stroke.Twenty individuals (age 61 ± 11 years; 52 ± 31 days poststroke) with severe motor limitations (Functional Ambulation Classification 0-2) were recruited for FC-RATE or conventional robotics-assisted treadmill exercise (RATE) (4 weeks, 3 × 30-minute sessions/wk). Outcome measures focused on peak cardiopulmonary performance parameters, training intensity, and feasibility, with examiners blinded to allocation.All 14 allocated participants (70% of recruited) completed the intervention (7/group, withdrawals unrelated to intervention), without serious adverse events occurring. Cardiovascular fitness increased significantly in both groups, with peak oxygen uptake increasing from 14.6 to 17.7 mL · kg · min (+17.8%) after 4 weeks (45.8%-55.7% of predicted maximal aerobic capacity; time effect P = 0.01; no group-time interaction). Training intensity (% heart rate reserve) was significantly higher for FC-RATE (40% ± 3%) than for conventional RATE (14% ± 2%) (P = 0.001).Substantive overall increases in the main cardiopulmonary performance parameters were observed, but there were no significant between-group differences when comparing FC-RATE and conventional RATE. Feedback-controlled robotics-assisted treadmill exercise significantly increased exercise intensity, but recommended intensity levels for cardiovascular training were not consistently achieved. Future research should focus on appropriate algorithms within advanced robotic systems to promote optimal cardiovascular stress.Video abstract available for more insights from the authors (Supplemental Digital Content 1, http://links.lww.com/JNPT/A107).

Project description:BackgroundLateral ankle sprains (LASs) are common injuries among military service members. Approximately 40% of individuals with an LAS progress to develop chronic ankle instability (CAI), a condition that results in substantial mechanical and neurophysiological impairment and activity limitation. Since proprioceptive and balance training improve functional outcomes and prevent secondary injury following LAS, they are recommended in clinical practice. Uneven treadmills are an innovative modality that challenge the sensorimotor system while performing an ecologically valid task simulating environments frequently encountered by service members with LAS and CAI.ObjectiveThe aim of this study is to evaluate whether the inclusion of uneven treadmill training in standard rehabilitation can improve clinical, functional, biomechanical, and patient-reported outcomes compared with the standard of care alone in service members with LAS and CAI. The prophylactic effects of treatment on secondary injury and identification of any contributing or mediating factors that influence outcomes following treatment will also be evaluated. We hypothesize that service members receiving uneven treadmill training will demonstrate greater improvements in clinical and instrumented measures of impairment, patient-reported function, and lower risk of injury recurrence than the control group immediately post and 18 months following treatment.MethodsA multisite, parallel randomized clinical trial will be performed among service members aged 18-49 years being treated for LAS and CAI in military treatment facilities in the United States. Participants randomly assigned and allocated to receive the experimental intervention will be provided up to 12 sessions of training on an uneven terrain treadmill over a 6-week treatment course to supplement standard rehabilitation care. Treatment intensity of the rehabilitation exercises and treadmill training will be progressed on the basis of patient-perceived intensity and treatment responses. Outcome measures will include patient-reported outcomes, functional assessments, performance measures, and biomechanical measures. Investigators collecting outcome measures will be blinded to treatment allocation. Reinjury rates and patient-reported outcomes of function will be tracked over 18 months following treatment.ResultsThe project was funded in September 2020. Patient recruitment began in November 2021, with 3 participants enrolled as of February 2022. Dissemination of the main study findings is anticipated in 2024.ConclusionsThis study will assess the impact of an innovative uneven-terrain treadmill on treatment outcomes in the rehabilitation of service members with LAS and CAI. The results of this study will be used to inform rehabilitation practices and to potentially improve functional outcomes and secondary prevention in this patient population.Trial registrationClinicalTrials.gov NCT04999904; https://clinicaltrials.gov/ct2/show/NCT04999904?term=NCT04999904.International registered report identifier (irrid)DERR1-10.2196/38442.

Project description:There are many consequences associated with having a stroke, all of which are important factors affecting long-term rehabilitation outcomes; these become important health issues for those of advanced age and require dedicated health strategies. High-intensity interval training (HIIT) is an effective training protocol used in cardiac rehabilitation programs; however, owing to the inter-individual variability in physiological responses to training associated with cardiovascular diseases, the exercise regimen given to each patient should be closely controlled and individualized to ensure the safety and efficiency of the exercise program. Heart rate variability (HRV) is currently being used for this purpose, as it is closely linked to parasympathetic nervous system activation, with high HRV scores associated with good cardiovascular adaptation. The objective of this protocol is to determine the effect of HIIT compared to HRV-guided training in terms of cardiorespiratory fitness, heart rate variability, functional parameters, body composition, quality of life, inflammatory markers, and cognitive function in patients who have had a stroke, as well as to assess the feasibility of patients undertaking an 8-week cardiac rehabilitation program, evaluating its safety and their adherence. The proposed protocol involved cluster-randomized controlled design in which the post-stroke patients are assigned either to an HRV-based training group (HRV-G) or a HIIT-based training group (HIIT-G). HIIT-G will train according to a predefined training program, whereas HRV-G will train depending on the patients' daily HRV. The outcomes considered are peak oxygen uptake (VO2peak), endothelial and work parameters, heart rate variability, functional parameters, relative weight and body fat distribution, quality of life, inflammatory markers and cognitive function, as well as exercise adherence, feasibility, and safety. It is expected that this HRV-guided training protocol will improve functional performance in patients following a stroke and be safer, more feasible, and generate improved adherence relative to HIIT, providing an improved strategy for to optimize cardiac rehabilitation interventions.

Project description:It is estimated that approximately 50% of stroke survivors will experience swallowing difficulty, or dysphagia. The associated sequelae of dysphagia include dehydration, malnutrition, and aspiration pneumonia, all of which have can have serious medical consequences. To improve swallowing safety and efficiency, alternative nutritional intake methods (for example, a feeding tube) or a modified diet texture (such as pureed foods or thickened liquids) may be recommended but these modifications may negatively affect quality of life. An alternative approach to treating dysphagia has emerged over the past few years, targeting stronger lingual muscles through maximal isometric pressure tasks. Although these studies have shown promising results, thin-liquid bolus control continues to be challenging for patients with dysphagia. Previous work investigating lingual pressures when healthy participants swallow has suggested that greater task specificity in lingual exercises may yield improved results with thin liquids.This is a small, exploratory randomized clinical trial being conducted with post-stroke patients 4 to 20 weeks after onset of dysphagia secondary to impaired lingual control. At enrollment, participants are randomly assigned to one of two treatment protocols, either tongue pressure profile training (TPPT) or the control treatment, tongue pressure strength-and-accuracy training (TPSAT). Each treatment protocol consists of 24 sessions of treatment over 8 to 12 weeks with monitoring of tongue pressure as well as a baseline and outcome videofluoroscopic swallowing study. Tongue pressure measures, videofluoroscopic measures, and functional outcome measures will be obtained following training of 60 participants (30 in each condition), to determine whether TPPT yields better outcomes.This study will continue to explore options beyond tube feeding and modified diets for people with neurogenic dysphagia following stroke. Should the novel protocol, TPPT, prove to be more effective than the TPSAT protocol, this may influence standards of care and best practices for patients with dysphagia involving impaired thin-liquid control as a result of stroke.Clinicaltrials.gov http://NCT01370083.

Dataset Information

Effects of inclined treadmill training on functional and cardiovascular parameters of stroke patients: study protocol for a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Effects of inclined treadmill training on functional and cardiovascular parameters of stroke patients: study protocol for a randomized controlled trial.

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