Modified Clavien-Dindo-Sink Classification System for operative complications in adult spine surgery.

OBJECTIVE: Currently there is no standardized mechanism to describe or compare complications in adult spine surgery. Thus, the purpose of the present study was to modify and validate the Clavien-Dindo-Sink complication classification system for applications in spine surgery. METHODS: The Clavien-Dindo-Sink complication classification system was evaluated and modified for spine surgery by four fellowship-trained spine surgeons using a consensus process. A distinct group of three fellowship-trained spine surgeons completed a randomized electronic survey grading 71 real-life clinical case scenarios. The survey was repeated 2 weeks after its initial completion. Fleiss' and Cohen's kappa (κ) statistics were used to evaluate interrater and intrarater reliabilities, respectively. RESULTS: Overall, interobserver reliability during the first and second rounds of grading was excellent with a κ of 0.847 (95% CI 0.785-0.908) and 0.852 (95% CI 0.791-0.913), respectively. In the first round, interrater reliability ranged from good to excellent with a κ of 0.778 for grade I (95% CI 0.644-0.912), 0.698 for grade II (95% CI 0.564-0.832), 0.861 for grade III (95% CI 0.727-0.996), 0.845 for grade IV-A (95% CI 0.711-0.979), 0.962 for grade IV-B (95% CI 0.828-1.097), and 0.960 for grade V (95% CI 0.826-1.094). Intraobserver reliability testing for all three independent observers was excellent with a κ of 0.971 (95% CI 0.944-0.999) for rater 1, 0.963 (95% CI 0.926-1.001) for rater 2, and 0.926 (95% CI 0.869-0.982) for rater 3. CONCLUSIONS: The Modified Clavien-Dindo-Sink Classification System demonstrates excellent interrater and intrarater reliability in adult spine surgery cases. This system provides a useful framework to better communicate the severity of spine-related complications.

Correction to: Adaptive capacity of 2- to 5-month-old infants to the flow, shape, and flexibility of different teats during bottle feeding: a cross-sectional study.

Following the publication of the article [1], the authors noticed that Fig. 3 used is not the updated version. The correct version is shown below.

Adaptive capacity of 2- to 5-month-old infants to the flow, shape, and flexibility of different teats during bottle feeding: a cross-sectional study.

BACKGROUND: Nutritive sucking is a complex activity, the biomechanical components of which may vary in relation to respiratory phase, swallow-rate per minute, suck-swallow ratio, and swallow non-inspiratory flow (SNIF). Quantitative measurement of these components during nutritive sucking in healthy infants could help us to understand the complex development of sucking, swallowing, and breathing. This is important because the coordination between these components is often disturbed in infants with feeding difficulties. The aims of this study were to describe the biomechanical components of sucking and swallowing in healthy 2- to 5-month-old infants during bottle feeding, to assess whether infants adapt to the characteristics of two different teats, and to determine which independent variables influence the occurrence of SNIF. METHODS: Submental muscle activity, nasal airflow, and cervical auscultation were evaluated during bottle-feeding with two different teats. RESULTS: Sixteen term-born infants (6 boys) aged 2-5 months were included. All infants showed variable inhalation and exhalation after swallowing. The swallow rate per minute was significantly higher when infants fed with a higher flow teat (Philips Avent Natural 2.0™). Infants had suck:swallow ratios ranging from 1:1 to 4:1. A suck:swallow ratio of 1:1 occurred significantly more often when infants fed with a higher flow teat, whereas a suck:swallow ratio of 2:1 occurred significantly more often when infants fed with a low-flow teat (Philips Avent Classic+™). A suck:swallow ratio of 1:1 was negatively correlated with SNIF, whereas a suck:swallow ratio of 2:1 was positively correlated with SNIF. CONCLUSION: Healthy infants aged 2-5 months can adapt to the flow, shape, and flexibility of different teats, showing a wide range of biomechanical and motor adaptations.

Is Fitbit Charge 2 a feasible instrument to monitor daily physical activity and handbike training in persons with spinal cord injury? A pilot study.

STUDY DESIGN: It is a longitudinal pilot study. OBJECTIVES: To investigate the feasibility of a low-cost and widely used fitness tracker with step count and heart rate data to monitor daily physical activity in wheelchair users with spinal cord injury (SCI). SETTING: Dutch community. METHODS: Six participants with SCI who were in training for a handbike event were recruited. They were asked to wear a Fitbit Charge 2® 24 h a day for at least 2 weeks and were questioned about the utility and user-friendliness of this device. RESULTS: Five out of six participants managed to wear the device nonstop for 2 weeks, and continued to wear the device after this initial period. Most participants were enthusiastic about the direct feedback provided by the tracker and reported the data to be accurate. Data collected during more than 2 months of three participants and during 8 months on one of them showed the possibility of detecting training days and observing interpersonal and intrapersonal variation in daily physical activity level. CONCLUSIONS: A commercially available, low-cost, self-monitoring multi-sensor wrist device or a fitness tracker like the Fitbit Charge 2® can be a promising instrument to monitor daily activity levels among wheelchair users with SCI. The free commercial dashboard and log data clearly show trends of variations in physical activity and increases in heart rate, which are of value to both researchers and clinicians interested in identifying training schedules of wheelchair athletes.

Health-related quality of life and its determinants in patients with metastatic renal cell carcinoma.

PURPOSE: Based on improvements of progression-free survival (PFS), new agents for metastatic renal cell carcinoma (mRCC) have been approved. It is assumed that one of the benefits is a delay in health-related quality of life (HRQoL) deterioration as a result of a delay in progression of disease. However, little data are available supporting this relationship. This study aims to provide insight into the most important determinants of HRQoL (including progression of disease) of patients with mRCC. METHODS: A patient registry (PERCEPTION) was created to evaluate treatment of patients with (m)RCC in the Netherlands. HRQoL was measured, using the EORTC QLQ-C30 and EQ-5D-5L, every 3 months in the first year of participation in the study, and every 6 months in the second year. Participation started as soon as possible following a diagnosis of (m)RCC. Random effects models were used to study associations between HRQoL and patient and disease characteristics, symptoms and treatment. RESULTS: Eighty-seven patients with mRCC completed 304 questionnaires. The average EORTC QLQ-C30 global health status was 69 (SD, 19) before progression and 61 (SD, 22) after progression of disease. Similarly, the average EQ-5D utility was 0.75 (SD, 0.19) before progression and 0.66 (SD, 0.30) after progression of disease. The presence of fatigue, pain, dyspnoea, and the application of radiotherapy were associated with significantly lower EQ-5D utilities. CONCLUSIONS: Key drivers for reduced HRQoL in mRCC are disease symptoms. Since symptoms increase with progression of disease, targeted therapies that increase PFS are expected to postpone reductions in HRQoL in mRCC.

Arthroscopic SLAP IIb Repair Using Knot-Tying Versus Knotless Suture Anchors: Is There a Difference?

The use of knotless suture anchors has increased in popularity; however, there is a paucity of literature examining the difference in clinical outcomes with traditional knotted fixation. It was hypothesized that knotless fixation would provide superior clinical outcomes, improved return to play (RTP), and lower revision rates as compared with traditional knotted fixation in the repair of SLAP IIb tears. Seventy-four athletes who underwent arthroscopic SLAP IIb repair with traditional (n = 42) and knotless anchors (n = 32) by a single surgeon were evaluated after a minimum 2-year follow. Demographic and surgical data, RTP, Kerlan-Jobe Orthopaedic Clinic (KJOC) score, American Shoulder and Elbow Surgeons (ASES) score, stability, strength, and pain scores were compared. Knotless anchors had slightly higher RTP (93.5% vs 90.2%, P = .94) and RTP at the same level (58.1% vs 53.7% P = .81) compared with knotted fixation, but the difference did not reach statistical significance. Knotless anchors were less likely to require revision surgery than traditional anchors (9% vs 17%, P = .50), but the difference was not statistically significant. When comparing knotless and traditional knotted suture anchor repair of type llb SLAP tears, knotless fixation required less revision surgery and had higher RTP, ASES, and KJOC scores; however, statistical significance was not achieved in this relatively small cohort.

Potential health gains for patients with metastatic renal cell carcinoma in daily clinical practice: A real-world cost-effectiveness analysis of sequential first- and second-line treatments.

INTRODUCTION: Randomised controlled trials have shown that targeted therapies like sunitinib are effective in metastatic renal cell carcinoma (mRCC). Little is known about the current use of these therapies, and their associated costs and effects in daily clinical practice. We estimated the real-world cost-effectiveness of different treatment strategies comprising one or more sequentially administered drugs. METHODS: Analyses were performed using patient-level data from a Dutch population-based registry including patients diagnosed with primary mRCC from January 2008 to December 2010 (i.e., treated between 2008 and 2013). The full disease course of these patients was estimated using a patient-level simulation model based on regression analyses of the registry data. A healthcare sector perspective was adopted; total costs included healthcare costs related to mRCC. Cost-effectiveness was expressed in cost per life-year and cost per quality-adjusted life-year (QALY) gained. Probabilistic sensitivity analysis was conducted to estimate the overall uncertainty surrounding cost-effectiveness. RESULTS: In current daily practice, 54% (336/621) of all patients was treated with targeted therapies. Most patients (84%; 282/336) received sunitinib as first-line therapy. Of the patients receiving first-line therapy, 30% (101/336) also received second-line therapy; the majority was treated with everolimus (40%, 40/101) or sorafenib (28%, 28/101). Current treatment practice (including patients not receiving targeted therapy) led to 0.807 QALYs; mean costs were €58,912. This resulted in an additional €105,011 per QALY gained compared to not using targeted therapy at all. Forty-six percent of all patients received no targeted therapy; of these patients, 24% (69/285) was eligible for sunitinib. If these patients were treated with first-line sunitinib, mean QALYs would improve by 0.062-0.076 (where the range reflects the choice of second-line therapy). This improvement is completely driven by the health gain seen amongst patients eligible to receive sunitinib but did not receive it, who gain 0.558-0.684 QALYs from sunitinib. Since additional costs would be €7,072-9,913, incremental costs per QALY gained are €93,107-111,972 compared to current practice. DISCUSSION: Health can be gained if more treatment-eligible patients receive targeted therapies. Moreover, it will be just as cost-effective to treat these patients with sunitinib as current treatment practice.

Associations between disability-management self-efficacy, participation and life satisfaction in people with long-standing spinal cord injury.

OBJECTIVES: To study disability-management self-efficacy (DMSE) and its correlates in a large sample of Dutch people with long-standing spinal cord injury (SCI). DMSE is the confidence that people with SCI may have in their ability to manage the consequences of their condition with respect to the various domains in their life. Research questions were: (1) What is the level of DMSE in Dutch people with long-standing SCI?; (2) Is DMSE associated with demographic and lesion characteristics?; and (3) Is DMSE associated with participation and life satisfaction if these associations are adjusted for demographic and lesion characteristics and mood? METHODS: Eligible people were identified from all eight rehabilitation centers with a specialty in SCI rehabilitation in the Netherlands (N=261). Data were collected using a self-report questionnaire. DMSE was measured using the University of Washington Self-Efficacy Scale-Short Form (UW-SES-6). Correlation and linear regression analyses were used. RESULTS: Levels of UW-SES-6 scores were largely independent of demographic and lesion characteristics. UW-SES-6 scores were bivariately moderately to strongly associated with mood (0.47), participation (0.39-0.51) and life satisfaction (0.46). In the regression analyses, UW-SES-6 scores still explained a significant amount of variance of participation (standardized ß 0.31-0.33) and life satisfaction (standardized ß 0.21) when controlling for demographic and lesion characteristics and mood, and explained an additional 3.2-8.1% of the variance of participation and life satisfaction. CONCLUSION: DMSE is a psychological resource associated with higher levels of participation and life satisfaction after SCI. The UW-SES-6 is a brief and easy to use measure of this psychological resource.

Effect of holding a racket on propulsion technique of wheelchair tennis players.

The purpose of this study was to determine possible differences in propulsion technique between propelling the wheelchair with and without a racket in the hand. Eight experienced wheelchair tennis players performed three submaximal exercise tests and six sprint tests on a wheelchair ergometer. Torque and velocity were measured during the tests and power output and timing variables were calculated. Differences between the conditions with and without racket were analyzed. When propelling with the racket, the racket side showed a significantly lower push time (P = 0.03), lower percentage push time (P = 0.001), shorter contact angle (P < 0.001), more power loss before (P = 0.006) and after (P = 0.001) the push, a higher peak (P = 0.009) and mean (P = 0.005) power output during the push, and a lower mean overall velocity (P = 0.03). When the same hand is compared when propelling with and without racket or when the sprint data were analyzed, similar significant differences were found. Propelling the wheelchair while holding a racket has negative effects on the propulsion technique and may lead to injuries of the upper extremity. The longer time needed to couple the hand with the racket to the rim leads to higher power losses and subsequently higher power output generation during the shorter push phase.

Variation in use of targeted therapies for metastatic renal cell carcinoma: Results from a Dutch population-based registry.

BACKGROUND: For patients with metastatic renal cell carcinoma (mRCC), targeted therapies have entered the market since 2006. The aims of this study were to evaluate the uptake and use of targeted therapies for mRCC in The Netherlands, examine factors associated with the prescription of targeted therapies in daily clinical practice and study their effectiveness in terms of overall survival (OS). METHODS: Two cohorts from PERCEPTION, a population-based registry of mRCC patients, were used: a 2008-2010 Cohort (n = 645) and a 2011-2013 Cohort (n = 233). Chi-squared tests for trend were used to study time trends in the use of targeted therapy. Patients were grouped based on the eligibility criteria of the SUTENT trial, the trial that led to sunitinib becoming standard of care, to investigate the use of targeted therapies amongst patients fulfilling those criteria. Multi-level logistic regression was used to identify patient subgroups that are less likely to receive targeted therapies. RESULTS: Approximately one-third of patients fulfilling SUTENT trial eligibility criteria did not receive any targeted therapy (29 % in the 2008-2010 Cohort; 35 % in the 2011-2013 Cohort). Patients aged 65+ years were less likely to receive targeted therapy in both cohorts and different risk groups (odds ratios range between 0.84-0.92); other factors like number of metastatic sites were of influence in some subgroups. Amongst treated patients, there was a decreasing trend in sunitinib use over time (p = 0.0061), and an increasing trend in pazopanib use (p = 0.0005). CONCLUSIONS: Targeted therapies have largely replaced interferon-alfa as first-line standard of care. Nevertheless, many eligible patients in Dutch daily practice did not receive targeted therapies despite their ability to improve survival. Reasons for their apparent underutilisation should be examined more carefully.

Dystrophic changes in masticatory muscles related chewing problems and malocclusions in Duchenne muscular dystrophy.

Dysphagia in Duchenne muscular dystrophy (DMD) worsens with age, with increasingly effortful mastication. The aims of this study were to describe mastication problems in consecutive stages in a group of patients with DMD and to determine related pathophysiological aspects of masticatory muscle structure, tongue thickness, bite force and dental characteristics. Data from 72 patients with DMD (4.3 to 28.0 years), divided into four clinical stages, were collected in a cross sectional study. Problems with mastication and the need for food adaptations, in combination with increased echogenicity of the masseter muscle, were already found in the early stages of the disease. A high percentage of open bites and cross bites were found, especially in the later stages. Tongue hypertrophy also increased over time. Increased dysfunction, reflected by increasingly abnormal echogenicity, of the masseter muscle and reduced occlusal contacts (anterior and posterior open bites) were mainly responsible for the hampered chewing. In all, this study shows the increasing involvement of various elements of the masticatory system in progressive Duchenne muscular dystrophy. To prevent choking and also nutritional deficiency, early detection of chewing problems by asking about feeding and mastication problems, as well as asking about food adaptations made, is essential and can lead to timely intervention.

A Comparison of Methods for the Estimation of Body Composition in Highly Trained Wheelchair Games Players.

The purpose of this study was to assess the agreement in body composition measurements of wheelchair athletes using skinfolds, bio-impedance analysis (BIA) and air displacement plethysmography (ADP) relative to dual-energy X-ray absorptiometry (DXA). A secondary objective was to develop new skinfold prediction equations to estimate %fat for this sample. 30 wheelchair games players were recruited and the body composition outcomes of BIA, ADP, and skinfolds were compared to the DXA outcomes by a paired-samples t-test (systematic bias), intraclass correlation (ICC, relative agreement) and Bland-Altman plots (absolute agreement). Regression models to predict the %fat as measured by DXA by the sum of skinfolds or BIA were calculated. Results showed that the predictions of %fat when using BIA, ADP or skinfolds systematically underestimated the %fat mass as measured by the DXA. All ICC values, except for the measurement of fat (kg) by ADP (ICC=0.702), were below 0.7. New prediction models found the ∑7 skinfolds and calf circumference as the best model to predict %fat (R(2)=0.84). In conclusion, BIA, ADP and existing skinfolds equations should be used with caution when estimating %fat of wheelchair athletes with substantial body asymmetry, lower body muscular atrophy and upper body muscular development.

Human Dermal Fibroblasts Demonstrate Positive Immunostaining for Neuron- and Glia- Specific Proteins.

In stem cell cultures from adult human tissue, undesirable contamination with fibroblasts is frequently present. The presence of fibroblasts obscures the actual number of stem cells and may result in extracellular matrix production after transplantation. Identification of fibroblasts is difficult because of the lack of specific fibroblast markers. In our laboratory, we isolate and expand neural-crest-derived stem cells from human hair follicle bulges and investigate their potential to differentiate into neural cells. To establish cellular identities, we perform immunohistochemistry with antibodies specific for glial and neuronal markers, and use fibroblasts as negative control. We frequently observe that human adult dermal fibroblasts also express some glial and neuronal markers. In this study, we have sought to determine whether our observations represent actual expression of these markers or result from cross-reactivity. Immunohistochemistry was performed on human adult dermal fibroblasts using acknowledged glial and neuronal antibodies followed by verification of the data using RT-qPCR. Human adult dermal fibroblasts showed expression of the glia-specific markers SOX9, glial fibrillary acidic protein and EGR2 (KROX20) as well as for the neuron-specific marker class III ß-tubulin, both at the protein and mRNA level. Furthermore, human adult dermal fibroblasts showed false-positive immunostaining for S100ß and GAP43 and to a lower extent for OCT6. Our results indicate that immunophenotyping as a tool to determine cellular identity is not as reliable as generally assumed, especially since human adult dermal fibroblasts may be mistaken for neural cells, indicating that the ultimate proof of glial or neuronal identity can only be provided by their functionality.

Exploratory analysis of candidate germline gene polymorphisms in breast cancer patients treated with neoadjuvant anthracycline-containing chemotherapy and associations with febrile neutropenia.

AIM: SNPs may be associated with (side) effects of chemotherapy and may be useful as biomarkers to predict febrile neutropenia. PATIENTS & METHODS: 187 DNA samples extracted from formalin-fixed paraffin-embedded tissue from patients with stage II/III HER2-negative breast cancer were genotyped. RESULTS: Candidate SNPs were selected and explored for association with febrile neutropenia and/or pathological complete response. TT genotype of 388 C>T in FGFR4 (rs351855) had a tendency toward higher incidence of febrile neutropenia during neoadjuvant chemotherapy, compared with the CT (p = 0.383) genotype and compared with the CC genotype (p = 0.068). CONCLUSION: The TT genotype of 388 C>T FGFR4 may be related to incidence of febrile neutropenia during neoadjuvant TAC (docetaxel, doxorubicin, cyclophosphamide) chemotherapy and is possibly useful as a patient-related risk factor when assessing febrile neutropenia risk. Original submitted 23 January 2015; Revision submitted 26 May 2015.

Hair follicle bulge cultures yield class III ß-tubulin-positive melanoglial cells.

Class III ß-tubulin (TUBB3)-positive cells from the hair follicle bulge are thought to be neuronal cells derived from a local neural crest stem cell. However, TUBB3 has recently been shown to be expressed in the melanocytic lineage. To evaluate the neural-crest-associated immunophenotype of TUBB3-positive cells from hair follicle bulge explants, we dissected hair follicle bulges out from mouse whisker pads and cultured for 1 month and assessed outgrowing cells by means of immunocytochemistry using the biomarkers TUBB3, nestin, NGFR, SOX9, TYRP1 and laminin. Large amounts of TUBB3-positive cells could be cultured that co-expressed nestin, NGFR, SOX9 and, to a lesser degree, TYRP1, matching a melanoglial phenotype. In addition, a small population of TUBB3-negative but laminin-positive cells was found, which presumably are of glial origin. It can be concluded that cells of melanoglial origin can easily be obtained from hair follicle bulge explants. These cells may be of use in experimental animal or human disease and wound healing models. Notably, the TUBB3-positive cells are of melanoglial rather than neuronal origin.

Functional hindrance due to spasticity in individuals with spinal cord injury during inpatient rehabilitation and 1 year thereafter.

STUDY DESIGN: Prospective cohort study. OBJECTIVE: To assess functional hindrance due to spasticity during inpatient rehabilitation and 1 year thereafter in individuals with spinal cord injury (SCI) and to determine factors that influence the hindrance. SETTING: Eight specialized rehabilitation centres in the Netherlands. METHODS: A total of 203 patients with recent SCI rated the hindrance they perceived due to spasticity in daily living at the start of active rehabilitation (t1), 3 months later (t2), at discharge (t3) and 1 year after discharge (t4). Hindrance was dichotomized into absent or negligible and present. Multilevel regression analyses were performed to determine the course of functional hindrance due to spasticity and its associations with possible determinants-namely, age, gender, cause, lesion level, motor completeness, spasticity and anti-spasticity medication. RESULTS: The percentage of individuals that indicated functional hindrance due to spasticity ranged from 54 to 62% over time and did not change significantly over time (Δt3t1 odds ratio (OR)=0.85, P=0.44; Δt3t2 OR=1.20, P=0.41; Δt3t4 OR=0.91, P=0.67). The percentage of individuals who experienced a lot of hindrance due to spasticity during specific activities ranged from 4 to 27%. The odds for experiencing functional hindrance due to spasticity were significantly higher for individuals with tetraplegia (OR=2.17, P=0.0001), more severe spasticity (OR=5.51, P<0.0001) and for those using anti-spasticity medication (OR=4.18, P<0.0001). CONCLUSION: Functional hindrance due to spasticity occurred in the majority of persons with SCI and did not change significantly during inpatient rehabilitation and 1 year thereafter. Factors that influence hindrance were determined.

Thyroid function alters during neoadjuvant chemotherapy in breast cancer patients: results from the NEOZOTAC trial (BOOG 2010-01).

This side study investigated the effect of chemotherapy on thyroid function and the extent to which it can predict pathological complete response (pCR) in patients with early breast cancer taking part in NEOZOTAC phase III trial, randomizing between neoadjuvant chemotherapy with or without additional zoledronic acid. Moreover, we examined the impact of thyroid function on toxicity. Serum samples of 38 patients were available for analyses. Free thyroxin (fT4) and thyroid stimulating hormone (TSH) levels were compared between baseline and before the 6th cycle and between subjects with and without pCR. The relation between toxicity and the variation in fT4 and TSH levels during chemotherapy was tested. Samples at baseline and before the 6th cycle were available for 31 and 21 patients, respectively. The mean baseline fT4 level was 16.0 pmol/L and TSH level 1.11 mU/L, and these did not differ between both arms at each time point. During six cycles of chemotherapy, fT4 levels decreased (p = 0.0001), and TSH levels increased significantly (p = 0.019). Interestingly, the decrease of fT4 was significantly greater in patients without nausea, vomiting, or neuropathy, than in patients with those side effects (p = 0.037, p = 0.043, and p = 0.050, respectively). Baseline TSH levels tended to be higher in patients with pCR (p = 0.035 univariate analysis and p = 0.074 multivariate analysis). Chemotherapy blunts thyroid function, which was associated with less side effects. These data urge further evaluation of the effects of thyroid function on toxicity and outcome of breast cancer therapy.

Effects of hybrid cycling versus handcycling on wheelchair-specific fitness and physical activity in people with long-term spinal cord injury: a 16-week randomized controlled trial.

STUDY DESIGN: This is an open randomized controlled trial. OBJECTIVE: The objective of this study was to investigate the effects of a 16-week hybrid cycle versus handcycle exercise program on fitness and physical activity in inactive people with long-term spinal cord injury (SCI). SETTING: The study was conducted in two rehabilitation centers with a specialized SCI unit. METHODS: Twenty individuals (SCI⩾8 years) were randomly assigned to a hybrid cycle (voluntary arm exercise combined with functional electrical stimulation (FES)-induced leg exercise) or a handcycle group. During 16 weeks, both groups trained twice a week for 30 min at 65-75% heart rate reserve. Outcome measures obtained before, during and after the program were fitness (peak power output, peak oxygen consumption), submaximal VO2 and heart rate (HR), resting HR, wheelchair skill performance time score) and physical activity (distance travelled in wheelchair and Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) score). Changes were examined using a two-factor mixed-measures analysis of variance. RESULTS: For all fitness parameters, except for submaximal VO2, no interaction effects were found. The hybrid cycle group showed a decrease in VO2 over time in contrast to the handcycle group (P=0.045). An overall reduction in HRrest (5±2 b.p.m.; P=0.03) and overall increase in PASIPD score (6.5±2.1; P=0.002) were found after 16 weeks of training. No overall training effects were found for the other fitness and activity outcome measures. CONCLUSION: In the current study, hybrid cycling and handcycling showed similar effects on fitness and physical activity, indicating that there seem to be no additional benefits of the FES-induced leg exercise over handcycle training alone.