Forced Rate Exercise + Rehab for Stroke
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The Cleveland Clinic
Disqualifiers: Cardiac arrhythmia, Hypertrophic cardiomyopathy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Traditional rehabilitation approaches are time and personnel intensive and costly, and leave \~75% of stroke survivors with residual disability. We propose a clinical trial to determine effects of forced aerobic exercise (FE; i.e., mechanically supplemented) in facilitating upper and lower extremity motor recovery post-stroke in an outpatient rehabilitation setting, to elucidate neural and biochemical substrates of FE-induced motor recovery, and to evaluate cost effectiveness of a FE-centered intervention compared to traditional stroke rehabilitation. The global effect of FE has the potential to enhance recovery in a growing population of stroke survivors in a cost-effective manner, thus accelerating its clinical acceptance.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are actively undergoing physical or occupational therapy, you cannot participate.
What data supports the effectiveness of the treatment Forced Rate Exercise + Rehab for Stroke?
Research shows that aerobic and task-oriented exercises can improve physical activity and motor function in stroke patients. These exercises help enhance cardiovascular health and mobility, which are crucial for recovery after a stroke.
12345Is Forced Rate Exercise safe for stroke patients?
Preliminary data suggest that high-intensity interval training (a form of Forced Rate Exercise) can be safe for stroke patients who have been prescreened with an ECG stress test and use a harness for fall protection, as no significant cardiovascular or orthopedic issues were reported during the sessions.
678910How is the Forced Rate Exercise treatment different from other stroke treatments?
Forced Rate Exercise is unique because it involves mechanically assisted aerobic exercise, which helps stroke survivors achieve moderate levels of exercise intensity without relying on traditional equipment like ergometers. This approach focuses on impairment-specific movements and can enhance both physical activity and brain reorganization after a stroke.
611121314Eligibility Criteria
This trial is for stroke survivors with residual disability who can participate in outpatient rehab. It's not suitable for those unable to perform forced aerobic exercise or have conditions that exclude them from traditional rehabilitation.Inclusion Criteria
I have weakness on one side of my body.
I had my first stroke 3-9 months ago, confirmed by a brain scan.
Individuals with chronic stroke able to provide informed consent
+3 more
Exclusion Criteria
I have been diagnosed with severe narrowing of the aortic valve in my heart.
I have been diagnosed with hypertrophic cardiomyopathy.
History of multiple strokes
+14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo forced aerobic exercise (FE) and rehabilitation to facilitate motor recovery post-stroke
12 weeks
24 sessions (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Participant Groups
The study compares the effectiveness of adding forced rate cycling (mechanically assisted exercise) to regular rehab versus standard rehab alone, focusing on motor recovery and cost-effectiveness.
2Treatment groups
Active Control
Group I: Forced Rate Exercise + RehabilitationActive Control1 Intervention
The forced rate exercise+rehab group (N=33) will complete FE on the cycle designed to augment pedaling rate to \>75 revolutions per minute (RPM). Target heart rate zone will be set to 60-80% of heart rate (HR) reserve. The session will consist of a 5-min warm-up, 35-min main exercise set, and 5-min cool down. Following FE, abbreviated sessions of motor learning-based training will be administered by a neurologic OT and PT experienced in stroke rehabilitation, with 30 min focused on restoration of UE function (OT) and 15 min focused on LE motor function/ gait training (PT).
Group II: RehabilitationActive Control1 Intervention
The rehab group will receive consecutive, full-length sessions of motor learning-based training, administered by a neurologic OT and PT experienced in stroke rehabilitation, with 45 min focused on restoration of UE function (OT) and 45 min focused on LE motor function/ gait training (PT).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland ClinicCleveland, OH
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Who Is Running the Clinical Trial?
The Cleveland ClinicLead Sponsor
References
Task-oriented aerobic exercise in chronic hemiparetic stroke: training protocols and treatment effects. [2016]Stroke is the leading cause of disability in older Americans. Each year 750,000 Americans suffer a stroke, two thirds of whom are left with neurological deficits that persistently impair function. Principal among them is hemiparetic gait that limits mobility and increases fall risk, promoting a sedentary lifestyle. These events propagate disability by physical deconditioning and "learned non-use," with further functional declines accelerated by the sarcopenia and fitness decrements of advancing age. Conventional rehabilitation care typically provides little or no structured therapeutic exercise beyond the subacute stroke recovery period, based on natural history studies showing little or no further functional motor recovery beyond 6 months after stroke. Emerging evidence suggests that new models of task-oriented exercise have the potential to improve motor function even years after stroke. This article presents treadmill as a task-oriented training paradigm to optimize locomotor relearning while eliciting cardiovascular conditioning in chronic stroke patients. Protocols for exercise testing and longitudinal aerobic training progression are presented that provide fundamental formulas that safely approach the complex task of customizing aerobic training to gait deficit severity in the high CVD risk stroke population. The beneficial effects of 6 months task-oriented treadmill exercise on cardiovascular-metabolic fitness, energy cost of hemiparetic gait, ADL mobility task performance, and leg strength are discussed with respect to the central and peripheral neuromuscular adaptations targeted by the training. Collectively, these findings constitute one initial experience in a much broader neuroscience and exercise rehabilitation development of task-oriented training paradigms that offer a multisystems approach to improving both neurological and cardiovascular health outcomes in the chronic stroke population.
Efficacy of interventions aimed at improving physical activity in individuals with stroke: a systematic review. [2021]Purpose: To identify interventions employed to increase post-stroke physical activity, evaluate their efficacy, and identify the gaps in literature.Materials and methods: Randomized controlled trials published until March 2018 were searched in MEDLINE, PEDro, EMBASE, LILACS, and SCIELO databases. The quality of each study and overall quality of evidence were assessed using the PEDro and the GRADE scales.Results: Eighteen studies were included (good PEDro and very low GRADE-scores). In seven, the experimental groups showed significant increases in physical activity (aerobics, resistance, and home-based training; counseling, aerobics, resistance, and home-based training; electrical stimulation during walking; functional-task training; robot-assisted arm therapy; accelerometer-based feedback, and physical activity encouragement). In seven, there were no significant between-group differences (physical activity plan; stretching, use of toe-spreaders, standard treatment; counseling; circuit video-game; functional-task; counseling and cognitive training). The combined experimental and control groups showed significant declines in physical activity in one study (aerobic training or stretching) and increases in three others (aerobic, resistance or sham resistance training; stroke-with advice or only stroke-counseling; aerobic training, educational sessions, standard treatment, and coaching, or mobilization and standard treatment). A meta-analysis could not be performed, due to heterogeneity.Conclusions: Some interventions improved physical activity after stroke. However, the interpretability is limited.Implications for rehabilitationIndividuals with stroke show low physical activity, which may compromise function and health.The use of interventions aimed at improving and maintaining physical activity of individuals with stroke are recommended.Some interventions, such as aerobic, resistance, and combined home-based training, electrical stimulation during walking, functional task training, and arm robot-assisted therapy, could improve the physical activity after stroke.
Exercise rehabilitation after stroke. [2018]Stroke is a leading cause of disability that results not only in persistent neurological deficits, but also profound physical deconditioning that propagates disability and worsens cardiovascular risk. The potential for exercise-mediated adaptations to improve function, fitness, and cardiovascular health after stroke has been underestimated: it represents an emerging arena in neurotherapeutics. To define the health rationale for cardiovascular (aerobic) exercise, we first outline the impact of debilitating secondary biological changes in muscle and body composition on fitness and metabolic health after stroke. We provide an overview of evidence-based advances in exercise therapeutics, with a focus on task-oriented models that combine a progressive aerobic conditioning stimulus with motor learning to improve multiple physiological domains that determine longitudinal outcomes after stroke. Although progress in development of safe and effective exercise strategies is advancing, fundamental questions regarding dose intensity, prescription to optimize central and peripheral neuromuscular adaptations, and the public health value of exercise in secondary stroke prevention remain unanswered. Key issues steering future research in exercise neurotherapeutics are discussed within the context of initiatives to facilitate translation to community-based studies, requisite for dissemination.
Effects of augmented exercise therapy time after stroke: a meta-analysis. [2022]To present a systematic review of studies that addresses the effects of intensity of augmented exercise therapy time (AETT) on activities of daily living (ADL), walking, and dexterity in patients with stroke.
Bihemispheric Motor Cortex Transcranial Direct Current Stimulation Improves Force Steadiness in Post-Stroke Hemiparetic Patients: A Randomized Crossover Controlled Trial. [2020]Post-stroke patients usually exhibit reduced peak muscular torque (PT) and/or force steadiness during submaximal exercise. Brain stimulation techniques have been proposed to improve neural plasticity and help to restore motor performance in post-stroke patients. The present study compared the effects of bihemispheric motor cortex transcranial direct current stimulation (tDCS) on PT and force steadiness during maximal and submaximal resistance exercise performed by post-stroke patients vs. healthy controls. A double-blind randomized crossover controlled trial (identification number: TCTR20151112001; URL: http://www.clinicaltrials.in.th/) was conducted involving nine healthy and 10 post-stroke hemiparetic individuals who received either tDCS (2 mA) or sham stimulus upon the motor cortex for 20 min. PT and force steadiness (reflected by the coefficient of variation (CV) of muscular torque) were assessed during unilateral knee extension and flexion at maximal and submaximal workloads (1 set of 3 repetitions at 100% PT and 2 sets of 10 repetitions at 50% PT, respectively). No significant change in PT was observed in post-stroke and healthy subjects. Force steadiness during knee extension (~25-35%, P
Intensifying Functional Task Practice to Meet Aerobic Training Guidelines in Stroke Survivors. [2020]Objective: To determine whether stroke survivors could maintain workloads during functional task practice that can reach moderate levels of cardiometabolic stress (i.e., ≥40% oxygen uptake reserve ([Formula: see text]O2R) for ≥20 min) without the use of ergometer-based exercise. Design: Cross-sectional study using convenience sampling. Setting: Research laboratory in a tertiary rehabilitation hospital. Participants: Chronic hemiparetic stroke survivors (>6-months) who could provide consent and walk with or without assistance. Intervention: A single bout of intermittent functional training (IFT). The IFT protocol lasted 30 min and involved performing impairment specific multi-joint task-oriented movements structured into circuits lasting ~3 min and allowing 30-45 s recovery between circuits. The aim was to achieve an average heart rate (HR) 30-50 beats above resting without using traditional ergometer-based aerobic exercise. Outcome measures: Attainment of indicators for moderate intensity aerobic exercise. Oxygen uptake ([Formula: see text]O2), carbon dioxide production ([Formula: see text]CO2), and HR were recorded throughout the 30 min IFT protocol. Values were reported as percentage of [Formula: see text]O2R, HR reserve (HRR) and HRR calculated from predicted maximum HR (HRRpred), which were determined from a prior maximal graded exercise test. Results: Ten (3-female) chronic (38 ± 33 months) stroke survivors (70% ischemic) with significant residual impairments (NIHSS: 3 ± 2) and a high prevalence of comorbid conditions (80% ≥ 1) participated. IFT significantly increased all measures of exercise intensity compared to resting levels: [Formula: see text]O2 (Δ 820 ± 290 ml min-1, p < 0.001), HR (Δ 42 ± 14 bpm, p < 0.001), and energy expenditure (EE; Δ 4.0 ± 1.4 kcal min-1, p < 0.001). Also, mean values for percentage of [Formula: see text]O2R (62 ± 19), HRR (55 ± 14), and HRRpred (52 ± 18) were significantly higher than the minimum threshold (40%) indicating achievement of moderate intensity aerobic exercise (p = 0.004, 0.016, and 0.043, respectively). Conclusion: Sufficient workloads to achieve moderate levels of cardiometabolic stress can be maintained in chronic stroke survivors using impairment-focused functional movements that are not dependent on ergometers or other specialized equipment.
High-intensity interval training in stroke rehabilitation. [2021]After stroke, people with weakness enter a vicious cycle of limited activity and deconditioning that limits functional recovery and exacerbates cardiovascular risk factors. Conventional aerobic exercise improves aerobic capacity, function, and overall cardiometabolic health after stroke. Recently, a new exercise strategy has shown greater effectiveness than conventional aerobic exercise for improving aerobic capacity and other outcomes among healthy adults and people with heart disease. This strategy, called high-intensity interval training (HIT), uses bursts of concentrated effort alternated with recovery periods to maximize exercise intensity. Three poststroke HIT studies have shown preliminary effectiveness for improving functional recovery. However, these studies were varied in approach and the safety of poststroke HIT has received little attention. The objectives of this narrative review are to (1) propose a framework for categorizing HIT protocols; (2) summarize the safety and effectiveness evidence of HIT among healthy adults and people with heart disease and stroke; (3) discuss theoretical mechanisms, protocol selection, and safety considerations for poststroke HIT; and (4) provide directions for future research.
Effect of high-intensity exercise on cardiorespiratory fitness in stroke survivors: A systematic review and meta-analysis. [2022]Knowledge of the optimal protocol and safety of particularly high-intensity exercise applied to individuals with stroke is lacking.
Adverse Events During Submaximal Aerobic Exercise Testing in People With Subacute Stroke: A Scoping Review. [2023]Concern for adverse cardiovascular events and limited guidance regarding how to conduct aerobic exercise (AEx) testing for individuals poststroke are key barriers to implementation by physical therapists in stroke rehabilitation. This study aimed to describe the nature and safety of submaximal AEx testing protocols for people with subacute stroke (PwSS) and the nature of comorbidity of PwSS who underwent submaximal AEx testing.
Preliminary safety analysis of high-intensity interval training (HIIT) in persons with chronic stroke. [2020]The purpose of this study was to assess safety via electrocardiographic (ECG), blood pressure (BP), heart rate (HR), and orthopedic responses to 3 different high-intensity interval training (HIIT) protocols in persons with stroke. Eighteen participants (10 male; 61.9 + 8.3 years of age; 5.8 + 4.2 years poststroke) completed a symptom-limited graded exercise test (GXT) with ECG monitoring to screen for eligibility and determine HR peak. The 3 HIIT protocols involved repeated 30 s bursts of treadmill walking at maximum speed alternated with rest periods of 30 s (P30), 1 min (P60), or 2 min (P120). Sessions were performed in random order and included 5 min warm up, 20 min HIIT, and 5 min cool down. Variables measured included ECG activity, BP, HR, signs and symptoms of cardiovascular intolerance, and orthopedic concerns. Generalized linear mixed models and Tukey-Kramer adjustment were used to compare protocols using p < 0.05. No signs or symptoms of cardiovascular intolerance, significant arrhythmias, ST segment changes, or orthopedic responses resulted in early termination of any HIIT session. HIIT elicited HRs in excess of 88% of measured HRpeak including 6 (P30), 8 (P60), and 2 (P120) participants eliciting a HR response above their GXT HRpeak. Both maximum BP and HR were significantly higher in P30 and P60 relative to P120. Preliminary data indicate that persons with chronic stroke who have been prescreened with an ECG stress test, a symptom-limited GXT, and a harness for fall protection may safely participate in HIIT, generating substantially higher HRs than what is seen in traditional moderate intensity training.
Feedback-controlled robotics-assisted treadmill exercise to assess and influence aerobic capacity early after stroke: a proof-of-concept study. [2016]The majority of post-stroke individuals suffer from low exercise capacity as a secondary reaction to immobility. The aim of this study was to prove the concept of feedback-controlled robotics-assisted treadmill exercise (RATE) to assess aerobic capacity and guide cardiovascular exercise in severely impaired individuals early after stroke.
Enhancing physical activity and brain reorganization after stroke. [2023]It is becoming increasingly clear that, if reorganization of brain function is to be optimal after stroke, there needs to be a reorganisation of the methods used in physical rehabilitation and the time spent in specific task practice, strength and endurance training, and aerobic exercise. Frequency and intensity of rehabilitation need to be increased so that patients can gain the energy levels and vigour necessary for participation in physical activity both during rehabilitation and after discharge. It is evident that many patients are discharged from inpatient rehabilitation severely deconditioned, meaning that their energy levels are too low for active participation in daily life. Physicians, therapists, and nursing staff responsible for rehabilitation practice should address this issue not only during inpatient rehabilitation but also after discharge by promoting and supporting community-based exercise opportunities. During inpatient rehabilitation, group sessions should be frequent and need to include specific aerobic training. Physiotherapy must take advantage of the training aids available, including exercise equipment such as treadmills, and of new developments in computerised feedback systems, robotics, and electromechanical trainers. For illustrative purposes, this paper focuses on the role of physiotherapists, but the necessary changes in practice and in attitude will require cooperation from many others.
Benefits of a repetitive facilitative exercise program for the upper paretic extremity after subacute stroke: a randomized controlled trial. [2016]Repetitive facilitative exercise (RFE), a combination of high repetition rate and neurofacilitation, is a recently developed approach to the rehabilitation of stroke-related limb impairment. Preliminary investigations have been encouraging, but a randomized controlled evaluation has yet to be performed.
Evaluation of exercise capacity after severe stroke using robotics-assisted treadmill exercise: a proof-of-concept study. [2022]Robotics-assisted treadmill exercise (RATE) with focus on motor recovery has become popular in early post-stroke rehabilitation but low endurance for exercise is highly prevalent in these individuals. This study aimed to develop an exercise testing method using robotics-assisted treadmill exercise to evaluate aerobic capacity after severe stroke.