Abstract
BACKGROUND:
Impaired mobility is related to low physical activity (PA) levels observed after stroke. Therapeutic approaches, such as task-specific circuit training (TSCT), used to improve mobility in individuals with stroke, could also improve PA levels.
OBJECTIVE:
To investigate the efficacy of TSCT, focused on both upper (UL) and lower (LL) limbs, in improving PA levels and mobility (primary outcomes), as well as muscle strength, exercise capacity, and quality of life (secondary outcomes) in subjects with stroke.
METHODS:
A randomized controlled trial with 36 subjects with chronic stroke was conducted. Experimental group: TSCT, involving both UL and LL. Control group: global stretching, memory exercises, and education sessions. Both groups received 60 minute sessions/week over 12 weeks. Outcomes were measured at baseline, post-intervention and 16 week follow-up.
RESULTS:
No changes were found for primary and secondary outcomes (0.11≤p≤0.99), except for quality of life, which improved in the experimental group post-intervention and 16 week follow-up (p = 0.02).
CONCLUSION:
TSCT focused on both UL and LL was not effective on PA levels and mobility of individuals with chronic stroke, however, improvements in quality of life were observed. Since this is the first study to investigate this combined training aimed at improving PA levels, future studies are necessary to better understand the impact of this type of intervention.
Introduction
The total burden of stroke has increased (Feigin, Norrving & Mensah, 2017). It is estimated that the burden of stroke is primarily due to modifiable risk factors, such as physical inactivity, which can lead to increased rate of disability, generating a vicious cycle that compromises health and functionality (Billinger et al., 2014; Feigin et al., 2013; Kernan et al., 2014).
There are a variety of factors related to the low physical activity (PA) levels observed after stroke (Thilarajah et al., 2018). One of these is impaired mobility, which leads to functional dependence, increased risk of falls, and low perception of quality of life (Langhorne, Coupar & Pollock, 2009; Pollock et al., 2014). Significant associations between measures of mobility and post-stroke PA levels have been previously reported (English et al., 2014; Field et al., 2013; Thilarajah et al., 2018). Thus, it is possible that therapeutic approaches aiming at improving mobility could also impact PA levels (Kringle et al., 2020).
Task-specific training is an approach based on motor learning methods that increase neural plasticity in Central Nervous System and uses practice of goal-directed, real-world, and context-specific tasks to enable individuals to undertake activities of daily living (Hubbard et al., 2009). The task-specific training can be organized in a circuit format, offered individually or in groups. Evidences has already shown that task-specific circuit training is effective in improving mobility of subjects with stroke and has important characteristics that favor its clinical applicability (English, Hillier & Lynch, 2017; Jeon, Kim & Park, 2015; Pollock et al., 2014). However, its effectiveness in improving PA levels of subjects with stroke is not well established.
Previous studies, which investigated the effects of task-specific training alone or combined with other interventions in improving PA levels of subjects with stroke showed conflicting results (Dean et al., 2012; Givon et al., 2016; Liao et al., 2012; Mudge, Barber & Stott, 2009; Pang et al., 2005; Shim & Jung, 2015; Vahlberg et al., 2017). Moreover, some of these studies used instruments not validated for stroke population (Mudge, Barber & Stott, 2009; Pang et al., 2005; Vahlberg et al., 2017) or did not provide a robust representation of PA level measure (Dean et al., 2012; Givon et al., 2016; Liao et al., 2012; Shim & Jung, 2015). Furthermore, these previous studies included activities involving only one body segment: upper limbs (UL) or lower limbs (LL). It is possible that training tasks involving both UL and LL could have a greater impact on mobility and, consequently, on PA levels.
The primary aim of this randomized controlled trial (RCT) was to investigate the efficacy of task-specific circuit training alone, focused on both UL and LL in improving PA levels and mobility in individuals with stroke. The secondary aim was to evaluate the effects of the training in improving muscle strength, exercise capacity, and quality of life.
Methods
Design
This study was designed as a parallel-group RCT with concealed allocation and blinded assessments. The randomization sequence was computer-generated in blocks of two and kept in sealed opaque envelopes. The envelopes were prepared prior to the study by a research assistant, who was not involved in the trial. Eligible participants were randomly allocated to either the experimental or control groups, based on the content of the sealed envelopes. A trained researcher, blinded to the participant allocation, collected sociodemographic, anthropometric, clinical data (Bowden et al., 2008; Michaelsen et al., 2011) and the outcomes from all eligible participants. The outcomes measures were assessed at baseline (week 0), post-intervention (week 12), and at 16 week follow-up. Participants were instructed not to inform the researcher the group they were assigned.
This study report followed the CONSORT statement guidelines (Schulz, Altman & Moher, 2010). This trial was approved by the Ethical Committee (#51453915.1.0000.5149) and registered at ClinicalTrials.gov (NCT02937480) before the recruitment started. The protocol was previously published (Martins et al., 2017).
Participants
Individuals with stroke were recruited from the general community, by contacting health centers and research groups. The recruitment occurred between June 2016 and November 2017. Those who met the following criteria were included: clinical diagnosis of stroke of at least six months; ≥19 years of age; ability to walk 10 meters independently (Pang, Harris & Eng, 2006); muscle tone of the elbow flexor muscles < 4 on the Modified Ashworth scale (Brashear et al., 2002); inactive or insufficiently active, based on standardized criteria (Centers for Disease Control and Prevention, 2001); and medical permission for regular practice of monitored PA. Individuals, who had cognitive impairments, as determined by Mini-Mental State Examination education-adjusted cutt-off scores (Bertolucci et al., 1994), and/or comprehensive aphasia (Teixeira-Salmela, Devaraj & Olney, 2007); history of severe heart disease and/or uncontrolled blood pressure; pain or other adverse health conditions, which could compromise the performance of the tests or their participation in the proposed interventions, were excluded. Volunteers were asked to provide written consent and not to enroll or participate in additional interventions during the course of the trial.
Interventions
The experimental and control interventions were delivered by the same physiotherapist, who had more than seven years of clinical and research experience in neurological rehabilitation. Research assistants were also involved in the intervention sessions and they were trained to assist the participants when necessary.
After allocation, all participants received 60 minute interventions, in groups of two to six, three-times a week over 12 weeks, totaling 36 sessions. Both interventions were provided in heath centers and laboratory settings. No task or guidance was provided to participants to be performed at home. Additional information on the interventions is reported in the previously published protocol (Martins et al., 2017).
Experimental group
The experimental group intervention consisted of a task-specific circuit training divided into 30 minutes of tasks for the UL and 30 minutes for the LL. The tasks were organized in a circuit with 11-station that included activities of reaching, grasping, manipulation of different objects, writing, sit-to-stand, step and heel raise activities, and walking. The protocol was based in previous studies and included tasks that are commonly limited in subjects with stroke. Details about each station were described in the published protocol (Martins et al., 2017). The participants performed five minutes of exercises in each station, except for the gait training with auditory cue, which lasted 10 minutes. One to two minute rest intervals between stations were allowed. Increases in speed, number of repetitions, and/or complexity of the tasks were used to progress the training. Participants received feedback on their performance and were encouraged to work as hard as possible and use their paretic limbs, as much as possible. Assistance was offered, only when necessary.
Control group
The control group intervention consisted of 40 minutes of static global stretching and 20 minutes of memory exercises, and/or health education sessions. Stretches were performed in three-series of 30 seconds and involved different muscle groups. Most of the stretches were performed in a sitting or lying position. When participants could not self-stretch, they received help. Memory exercises included various activities: memory games, remembering the sequence of objects, bingo, speaking names (of animals, food, objects, people, and places), singing passages of music. Health education sessions included information on risk factors for stroke, the importance of correct consumption of medications and fluid intake, frequency of medical consultations, and quality of sleep. More details about the control group intervention were described in the published protocol (Martins et al., 2017).
Primary outcomes
Primary outcomes were PA levels and mobility. PA level was directly measured by PA monitor and self-report questionnaire. These two measurement methods are complementary in providing more robust information on PA levels (Ainsworth et al., 2015). Mobility was assessed by measures involving both the UL and LL.
The PA monitor (SenseWear® multisensory; Body Media, Pittsburgh, PA, USA; software version 8.1) was used for the directly measurement of PA (Ainsworth et al., 2015; Fini et al., 2015; Mackey et al., 2011) which has shown adequate measurement properties for subjects with stroke (Moore et al., 2012). The data captured by the multiple sensors were integrated with the characteristics of the participants (age, height, body mass, sex, and smoking habit) in an algorithm that estimated PA level (Mackey et al., 2011). The participants were instructed to use the monitor attached to their non-paretic UL (back of the arm) over seven days and only remove it for bathing or when performing water-based activities (Mackey et al., 2011). Measurements of the averaged total daily energy expenditure (kilojoules) were obtained from the report generated by the software (Mackey et al., 2011), based on full five days of SenseWear® monitor data.
The Human Activity Profile (HAP) was used for self-report measurement of PA, has clinical applicability (Martins et al., 2019) and adequate measurement properties for subjects with stroke (Teixeira-Salmela, Devaraj & Olney, 2007). The HAP adjusted activity score (AAS), which is obtained by subtracting the number of activities that the subject stopped performing from that with the highest energy expenditure that the subject can perform (Fix & Daughton, 1988), was registered for analysis.
The 10 meter walk test, at both comfortable and maximum speeds (in m/s) was used to measure LL mobility. This test has shown to be valid and reliable for subjects with stroke (Faria et al., 2012; Salbach et al., 2001; Tyson & Conell, 2009). The instructions to perform the test were standardized (Nascimento et al., 2012) and, only one trial has shown to provide consistent and reliable results (Faria et al., 2012).
The Test d’Évaluation des Membres Supérieurs de Personnes Agées (TEMPA) was used to assess UL mobility. The TEMPA has shown adequate measurement for subjects with stroke (Michaelsen et al., 2008). Only the four bilateral TEMPA tasks were assessed and the time (in seconds) spent to perform them was registered for analysis (Michaelsen et al., 2008, 2011). After the demonstration and familiarization of the task, only one repetition was performed (Michaelsen et al., 2011).
Secondary measures
Secondary outcomes included muscle strength, exercise capacity, and quality of life, which were assessed by valid and reliable measures (Fulk et al., 2008; Martins et al., 2015, 2016; Tyson & Conell, 2009; Williams et al., 1999).
Muscle strength was bilaterally assessed with portable dynamometry (kilogram-force). Handgrip strength and knee extension strength were chosen because they represent the global muscular strength of UL and LL, respectively (Aguiar et al., 2019a; Martins et al., 2015). Handgrip strength was measured with hydraulic handgrip dynamometer (SAEHAN Corporation, Korea; Model SH5001) and knee extension strength was measured with digital hand-held dynamometer (Hoggan Health Industries, UT, USA). For the handgrip strength test, the participant remained seated in a chair without arm support, with the shoulder in adduction, neutral rotation, elbow flexed at 90°, forearm in neutral position and wrist in slight extension (between 0° and 30°). For the knee extension strength test, the participant remained seated on a chair, following previously recommended procedures (Bohannon, 1986; Figueiredo et al., 2007). After familiarization, only one repetition was obtained (Aguiar et al., 2019b).
Exercise capacity was assessed by the distance covered (meters) during the six minute walk test (6MWT), following the American Thoracic Society guidelines (ATS, 2002), except that the corridor was 25 meter long (Dunn et al., 2015). After demonstration, only one repetition was obtained (Liu et al., 2008).
Quality of life was assessed by the Stroke-Specific Quality of Life (SSQOL) scores, following recommended procedures (Williams et al., 1999).
Attendance and adherence to the protocol
Information on attendance to the sessions and adherence to the proposed protocol was collected. Attendance was measured by recording the number of sessions that each participant attended and the ratio between the number of attended sessions divided by the number of offered sessions (Scianni, Teixeira-Salmela & Louise, 2012) was calculated.
Adherence was measured by recording the number of sessions that each participant completed the full 60 minute training and performed all the training tasks, including the progressions. The ratio between the number of completed sessions was divided by the total number of attended sessions (Scianni, Teixeira-Salmela & Louise, 2012).
Sample size
Sample size was calculated to detect a between-group difference of 0.15 m/s in gait speed, with a power of 80%, and a significance level of 5%, using data from a previous RCT (Yang et al., 2006) with a similar population and intervention. In this study (Yang et al., 2006), the baseline gait speeds of the experimental and control groups were 0.84 (0.13) and 0.78 (0.14) m/s and after intervention they were 0.93 (0.14) (p < 0.001) and 0.78 (0.15) m/s (p = 0.80), respectively. Based on these values, 30 participants were required. Assuming a dropout rate of 15%, 36 participants were recruited (18 per group).
Statistical analysis
Descriptive statistics and tests for normality and homoscedasticity were employed for the continuous variables. All analysis was conducted on an intention-to-treat basis by an independent researcher using the SPSS software (SPSS Inc., Chicago, IL, USA; 17.0 version) (α= 5%). The data from the last available assessment were carried forward. Mixed 2*3 ANOVA was employed to investigate the main and interaction effects between the groups (experimental and control) and time (0, 12, and 16 weeks). In the published protocol (Martins et al., 2017), four repeated measurements were planned (0, 12, 16, and 24 weeks). However, 13 participants (57%) did not return for the 24 week follow-up and, therefore, the 24 week follow-up data were not analyzed. The trial ended in August 2018, after the collection of the 24 week follow-up data was concluded. The mean between-group and within-group differences along with the 95% confidence intervals were reported.
Results
Flow of the participants
Fifty potential subjects were screened, 12 (24%) were not eligible and two (4%) declined to participate. The 36, who were eligible and provided consent, were allocated to either the experimental (n = 18) or control (n = 18) groups (Fig. 1). The clinical and demographic characteristics of the participants are shown in Table 1.

Flow of participants through the trial.
Baseline characteristics of the participants of both groups
IQR = interquartile range; UL = Upper limb; LL = Lower limb.
The mean attendance for the experimental and control groups was 86% (SD 10) and 75% (SD 16), respectively. The main reasons for non-attendance were medical appointments, illness, difficulties with transportation, and travel.
The mean adherence rate was 72% (SD 19) for the experimental group, ranging from 35 to 100%, and 95% (SD 6) for the control group, ranging from 77 to 100%. Only six (33%) participants of the experimental group had adherence ≥80%. The reasons for the non-adherence were delays, LL pain, dizziness, malaise, and fatigue. There were no adverse events related to the interventions.
Effects of the interventions
The means (SD), within-group differences (SD), and between-group differences (95% CI) for all the primary and secondary outcomes are provided in Tables 2 and 3, respectively. There were not found any interactions or between-group effects for any of the outcomes, except for quality of life, which improved for the experimental group after intervention and 16 week follow-up (p = 0.02).
Mean (SD) of groups, mean (SD) within-group differences, and mean (95% CI) between-group differences for the primary outcomes
Mean (SD) of groups, mean (SD) within-group differences, and mean (95% CI) between-group differences for the primary outcomes
Exp = experimental group; Con = control group; HAP AAS = Human activity profile adjusted activity score; TEMPA = Test d’Évaluation des Membres Supérieurs de Personnes Agées.
Mean (SD) of groups, mean (SD) within-group differences, and mean (95% CI) between-group differences for the secondary outcomes
Exp = Experimental group; Con = Control group; 6MWT = Six minute walk test; SSQOL = Stroke Specific Quality of Life Scale.
Task-specific circuit training targeted to both UL and LL was not effective in improving PA levels and mobility (primary outcomes), nor muscle strength and exercise capacity (secondary outcomes) of subjects at the chronic phase post-stroke. Between-group differences were found only for quality of life, favoring the experimental group.
A recent systematic review indicated that task-specific training is an approach that has the potential to increase PA levels in subjects with stroke (Aguiar et al., 2020). Only two previous studies showed that task-specific training, focused on UL, was able to improve PA levels in subjects with stroke (Liao et al., 2012; Shim & Jung, 2015). Nevertheless, it is worth mention that one of these studies (Liao et al., 2012) involved a mixed intervention (task-specific training and robotic therapy) and the other have low methodological quality (Shim & Jung, 2015). To the best of our knowledge, this is the first study to investigate the effect of combined UL and LL task-specific circuit training alone on PA levels of individuals at the chronic phase of stroke, using more accurate measures.
Despite the fact that our findings failed to support the premise that task-specific circuit training could improve PA levels in subjects with chronic stroke, this RCT allow us to discuss some points of conducting this type of intervention. The lack of change in PA levels could be explained by the fact that the inclusion criterion regarding PA level was, in fact, based on the participants’ levels of exercise, including only those, who were considered inactive or insufficiently active (Centers for disease control and prevention, 2001). Considering that exercise consists of a planned and structured PA, exercise level encompasses only a part of the PA continuum (Caspersen, Powell & Christenson, 1985). Therefore, the inclusion criterion used in the present study may not have been sufficient to prevent the entry of subjects with higher PA levels and, thus, with lower potential for changes. Further studies should consider measures of PA levels for the selection of participants. One possibility would be to use the HAP cut-off points to select inactive subjects.
Another point that needs to be adjusted is the management of a task-specific training focused on both UL and LL tasks. Previous studies that investigated the effects of task-specific training in individuals at the chronic phase post-stroke included tasks focused on UL or LL separately or trained dual-motor tasks that required UL use (Dean, Richards & Malouin, 2000; Dean et al., 2012; Salbach et al., 2004; Yang et al., 2006). In the present study, the 60 minute sessions were divided into stations with tasks for both the UL and LL. It is possible that just 30 minutes of training for the UL and LL was not enough to result in improvements. Studies have suggested that increasing the number of repetitions in task-specific training resulted in improved functional outcomes (Lohse, Lang & Boyd, 2014; Outermans et al., 2010, Wadell et al., 2014; Wallace et al., 2010). Thus, one possibility for the implementation of task-specific training targeting both UL and LL could be by organizing the stations, so that they would include tasks that require the involvement of the UL and LL simultaneously, such as walking and carrying objects of various dimensions and weight.
We hypothesized that improvements in mobility associated with the task-specific circuit training would lead to improvements in PA levels. However, the results did not confirm this hypothesis. The lack of observed changes in mobility were not expected, since systematic reviews have already demonstrated the efficacy of task-specific training in improving this outcome (English, Hillier & Lynch, 2017; Jeon, Kim & Park, 2015). This finding may be due to the characteristics of the participants, which had mild to moderate impairments in UL and LL and walked at higher speeds, compared to those of previous studies which offered task-specific training (Dean, Richards & Malouin, 2000; Dean et al., 2012; Salbach et al., 2004). Most of the participants (69%) walked at speeds >0.8 m/s, ie, they had full-community walking status (Bowden et al., 2008). Thus, it is possible that they had less potential to increase or improve mobility.
Another possible explanation for these results is related to the adherence to the study protocol. In general, the participants of the experimental group had a higher attendance to the intervention sessions (86%), but their adherence to the protocol was only moderate (72%). Moreover, there was a large variability in adherence of the participants of the experimental group, since less than half had adherences ≥80%. Studies with elderly suggested that the minimum recommended adherence rate should range from 80 to 85%, to ensure that the results of the intervention are effective and reliable (Illiffe et al., 2010; Picorelli et al., 2015). Thus, the reduced adherence of the participants of the experimental group to the intervention may explain the lack of changes in all outcomes, except quality of life. The understanding of the factors that affect adherence of patients to this type of intervention is important to create strategies to improve their participation. These results also draw our attention to the importance of not only analyzing attendance of the participants to the sessions, but also their compliance with the entire study protocol.
In the present study, training targeting both UL and LL tasks was also not effective in improving muscle strength and exercise capacity. Muscle strength has a non-linear relationship with functionality (Bohannon et al., 2007), including mobility outcomes. Previous findings (Yang et al., 2006) demonstrated that task-specific training led to increases in muscle strength and functional improvements. However, the focus of this type of training is on functionality and repeated action of the task and not on muscle strengthening (Jeon, Kim & Park, 2015). The fact that the participants in the present study did not have significant baseline deficits in functionality may also explain the lack of changes in this outcome.
Exercise capacity is commonly assessed in studies using task-specific training. This is because, together with mobility, it is an important outcome that influences locomotion of individuals with stroke (Jeon, Kim & Park, 2015; Mudge, Barber & Stott, 2009). The proposed intervention included few locomotion activities, such as walking. Furthermore, the opportunity for training walking activities may not have been enough to induce changes in exercise capacity.
Significant improvements in quality of life at post-intervention and follow-up phases were found, favoring the experimental group. It is important to note that quality of life is a multidimensional construct that involves, at least, physical, emotional, and social dimensions (Geyh et al., 2007). Changes in quality of life through therapeutic interventions have a substantial impact on the lives of individuals with stroke. Thus, the proposed intervention may have contributed to improved emotional and social interactions, as the participants became aware of their skills. Despite being an important health outcome (Thilarajah et al., 2018; Winstein et al., 2016), quality of life has been poorly investigated in studies using task-specific training in subjects with stroke. There was found only one study (Dean et al., 2012) that assessed quality of life associated with LL task training. Unlike the present findings, no significant between-group differences were found. However, this study (Dean et al., 2012) only assessed the physical and mental dimensions of quality of life using a generic questionnaire, which may explain the differences in results. It is worth to mention that the improvement in quality of life observed for the experimental group was maintained at 16 week follow-up. This result demonstrates that UL and LL task-specific training resulted in long-term benefits on the participants’ lives.
Study limitations
The sample was of convenience, which limits the generalization of the findings. Furthermore, the trained tasks were standardized, to facilitate group intervention and provide the same experience to all participants. However, these tasks may not have been relevant to all of participants, influencing the transfer of skills to the context of their real lives. The loss of participants at the 24 week follow-up is another limitation, since the dropout rate was higher than that which was initially estimated (15%). Finally, although sample size was calculated a priori, it may not have had enough statistical power to detect changes between the groups in the assessed outcomes.
Conclusion
Task-specific circuit training focused on both UL and LL was not effective in improving PA levels, mobility, muscle strength and exercise capacity in subjects at the chronic phase post-stroke. Significant between-group differences were only found for quality of life at post-intervention and 16 week follow-up, favoring the experimental group. Since this is the first study to investigate the efficacy of a combined UL and LL task-training in improving PA levels, further studies are necessary to better understand the impact of this type of intervention.
Conflict of interest
The authors declare that they have no conflict of interest.
Footnotes
Acknowledgments
This clinical trial was conducted in accordance with the recommended ethical framework and has received approval from the institutional ethical review committee. The study was funded by the following research funding agencies: Coordenação de Aperfeiçoamento de Pessoal Ensino Superior (CAPES –Financial Code 001), Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), Fundação de Amparo à Pesquisa de Minas Gerais (FAPEMIG), and Pró-reitoria de Pesquisa da Universidade Federal de Minas Gerais (PRPq/UFMG).
