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1.

Objective:

Electrical stimulation of pudendal urethral afferents generates coordinated micturition in animals and bladder contractions in men after spinal cord injury (SCI), but there is no evidence of an analogous excitatory urethra-spinal-bladder reflex in women. The objective of this study was to determine whether electrical stimulation of the urethra could evoke bladder contractions in a woman with SCI.

Case Report:

A 38-year-old woman with a C6 ASIA A SCI who managed her bladder with clean intermittent catheterization and oxybutynin demonstrated neurogenic detrusor overactivity on urodynamics. Oxybutynin was discontinued 2 days prior to urodynamic testing with a custom 12F balloon catheter mounted with ring-shaped electrodes located in the bladder neck, mid urethra, and distal urethra. The inflated balloon was placed against the bladder neck to stabilize the catheter electrodes in place along the urethra. However, the balloon limited emptying during contractions. Urodynamics were performed at a filling rate of 25 mL/minute until a distention-evoked bladder contraction was observed. The urethra was stimulated over a range of bladder volumes and stimulus parameters to determine whether electrical stimulation could evoke a bladder contraction.

Findings:

Electrical stimulation via urethral electrodes evoked bladder contractions that were dependent on bladder volume (>70% capacity) and the intensity of stimulation.

Conclusions:

This is the first report of an excitatory urethra-spinal-bladder reflex in a woman with SCI. Future studies will determine whether this reflex can produce bladder emptying.  相似文献   

2.

Objective

Electrical stimulation of the urethra can evoke bladder contractions in persons with spinal cord injury (SCI). The objective of this study was to determine whether electrical stimulation of the urethra could evoke bladder contractions that empty the bladder.

Methods

The first patient was a 45-year-old man with a T6 ASIA A SCI secondary to a gunshot wound 15 years prior. The second patient was a 51-year-old man with a T2 ASIA A SCI secondary to a fall from scaffolding 2 years prior. Both patients demonstrated neurogenic detrusor overactivity on urodynamics and managed their bladder with clean intermittent catheterization and oxybutynin medication. Following informed consent, each patient discontinued oxybutynin 2 days prior to urodynamic testing. Urodynamics were performed with a custom 12 French balloon catheter mounted with ring-shaped electrodes (3 mm) positioned in the prostatic urethra. After filling the bladder to approximately three-fourth of capacity at a rate of 25 ml/minute, the urethra was stimulated with a range of parameters to determine whether electrical stimulation could evoke a bladder contraction and empty the bladder.

Results

Electrical stimulation of the prostatic urethra evoked bladder contractions (peak detrusor pressures of 60–80 cm H2O) that emptied the bladder in both subjects. In the first subject, stimulation (9–12 mA, 20 Hz) emptied 64–75%, leaving post-void residual volumes (PVRs) of 41–20 ml. In the second subject, stimulation (20 mA, 20 Hz) emptied 68–77%, leaving PVRs of 56–45 ml.

Conclusion

Urethral stimulation evoked bladder emptying in persons with SCI.  相似文献   

3.

Introduction:

Sacral neuromodulation (SNM) is an effective treatment modality for several urological problems, including neurogenic bladder. However, the invasiveness of this technique makes it unsuitable for many patients. We present a novel transdermal amplitude-modulated signal (TAMS) that may provide a non-invasive alternative to implantable SNM to treat neurogenic detrusor overactivity (NDO).

Methods:

In this study, we investigated the mechanism of action of non-invasive SNM using TAMS on our established spinal cord injury (SCI) animal model. We demonstrated that spinally transected rats develop urinary bladder hyper-reflexia after 3 weeks of SCI, indicated by the presence of uninhibited contractions, increased resting pressure, increased threshold pressure and increased maximum voiding pressure.

Results:

Short-term neurostimulation affected urodynamics parameters by significantly reducing the threshold pressure (p = 0.02). Spinal transection also increased calcitonin gene-related protein (CGRP) concentration in the L6 dorsal root ganglia; whereas, neurostimulation significantly reduced CGRP concentration in L6 (p = 0.03).

Conclusion:

TAMS caused a reduction in NDO by inhibiting C-fibre activity.  相似文献   

4.
Study Type – Aetiology (case control) Level of Evidence 3c What's known on the subject? and What does the study add? Neurogenic detrusor overactivity (NDO) and autonomic dysreflexia (AD) are common outcomes following spinal cord injury (SCI). In this study, we showed that onabotulinumtoxinA controlled NDO and AD in rats with T4‐SCI, and also provided a mechanism for the control of AS.

OBJECTIVE

  • ? To assess the significance of onabotulinumtoxinA (onabotA) intravesical administration in blocking autonomic dysreflexia (AD) response induced by cystometrogram (CMG) after T4 spinal cord transection (SCT).

MATERIALS AND METHODS

  • ? Female rats were stratified into three groups: a sham group; a SCT‐only group; and a SCT with onabotA treatment group. Each group was further subdivided into two subgroups: AD assessment, or nerve growth factor (NGF) assessment via enzyme‐linked immunosorbent assay (ELISA).
  • ? Three weeks after T4‐SCT, all groups were assessed. Arterial pressure and heart rate were measured during and after CMG.
  • ? NGF was also extracted from the bladder and the dorsal root ganglia (DRG) of the T4 root and quantified by ELISA. In the onabotA‐treated group, 48 h before assessment, onabotA (1 mL, 20 U/mL in saline) was given using a urethral tube and was left indwelling for 30 min.
  • ? Univariate anova was used to analyse the data and statistical significance was set at P < 0.05.

RESULTS

  • ? The maximum voiding pressure and the number of uninhibited contractions were significantly lower in the group treated with intravesical onabotA than in the SCT‐only group.
  • ? Intravesical onabotA significantly blocked the dysreflexia response (high arterial pressure with bradycardia) induced by CMG after SCT.
  • ? Intravesical onabotA also significantly lowered NGF concentrations in the bladder and the T4 DRG segment.

CONCLUSIONS

  • ? The results of the present study showed that intravesical onabotA controls neurogenic detrusor overactivity and AD after SCT.
  • ? The findings shed light on the potential benefits of intravesical onabotA treatment in patients with spinal cord injury, and also provide a novel mechanism for the control of AD via a minimally invasive treatment modality.
  相似文献   

5.

Objectives

To study the correlation between neurological level of spinal injury and bladder functions as detected by urodynamic study.

Study design

Analytical study.

Setting and participants

Seventy individuals with traumatic spinal cord injury (SCI) admitted to the Department of Physical Medicine and Rehabilitation, S.M.S. Medical College and Hospital, Jaipur. Detailed clinical, neurological evaluation as per American Spinal Injury Association Classification and radiological assessment were done along with clinical examination of bladder and urodynamic study.

Results

Out of 65 patients with suprasacral injuries, 53 (81.5%) demonstrated hyperreflexia with or without detrusor sphincter dyssynergia, 6 (9.2%) detrusor areflexia, and 6 (9.2%) had normal bladders, 41 (59.4%) low compliance (<20 ml/cmH2O), and 47 (72.30%) had high detrusor leak pint pressures (>40 cmH2O). Of the five patients with sacral injuries, one (20%) showed detrusor hyperreflexia, four (80%) detrusor areflexia, and one (20%) had low bladder compliance; all five (100%) had high detrusor leak point pressures.

Conclusions

The correlation between somatic neurologic findings, spinal imaging studies, and urodynamic findings in patients with SCI is not exact. Therefore, bladder management should not completely rely only on clinical bladder evaluation or neurological examination alone, but should always include urodynamic studies.  相似文献   

6.

Introduction and hypothesis

The aim of this study was to assess the efficacy of duloxetine in an animal model of detrusor overactivity induced by depression.

Methods

After 6 weeks of 13-cis-retinoic acid administration at a dose of 1 mg/kg/day, rats were given duloxetine at a dose of 1 mg/kg. This was followed by conscious cystometry, a forced swim test, and locomotor activity measurement. The levels of corticotropin-releasing factor (CRF) in the hypothalamus, amygdala and plasma were also determined.

Results

Duloxetine treatment led to a reduction in detrusor overactivity symptoms induced by the retinoid. Decreases were observed in cystometric parameters including the detrusor overactivity index, and the amplitude and frequency of nonvoiding contractions, while increases were seen in bladder compliance and the volume threshold to elicit nonvoiding contractions. No statistically significant differences were found in basal pressure, threshold pressure, micturition voiding pressure, postvoid residual , volume threshold, voiding efficiency, intercontraction interval, bladder contraction duration or relaxation time. Duloxetine also reduced the immobility time to that observed in control animals, while it did not affect locomotor activity. Its effects also included lowering of the CRF levels in the hypothalamus, amygdala and plasma, which increased following the prior administration of the retinoid. The plasma level of 13-cis-retinoic acid in rats corresponded to the levels found in humans.

Conclusions

This is the first study showing the efficacy of duloxetine in an animal model of detrusor overactivity induced by depression. Further studies in patients with detrusor overactivity and coexisting depression are warranted to confirm these experimental results.
  相似文献   

7.

Context

Preliminary research suggests that functional electrical stimulation cycling (FESC) might be a promising intervention for youth with spinal cord injury (SCI).

Objective

To review the evidence on FESC intervention in youth with SCI.

Methods

Systematic literature searches were conducted during December 2012. Two reviewers independently selected titles, abstracts, and full-text articles. Of 40 titles retrieved, six intervention studies met inclusion criteria and were assessed using American Academy for Cerebral Palsy and Developmental Medicine Levels of Evidence and Conduct Questions for Group Design.

Results

The study results were tabulated based on levels of evidence, with outcomes categorized according to the International Classification of Functioning, Disability, and Health framework. Evidence from the six included studies suggests that FESC is safe for youth with SCI, with no increase in knee/hip injury or hip displacement. Results from one level II randomized controlled trial suggest that a thrice weekly, 6-month FESC program can positively influence VO2 levels when compared with passive cycling, as well as quadriceps strength when compared with electrical stimulation and passive cycling.

Conclusions

FESC demonstrates limited yet encouraging results as a safe modality to mitigate effects of inactivity in youth with SCI. More rigorous research involving a greater number of participants is needed before clinicians can be confident of its effectiveness.  相似文献   

8.

Introduction and hypothesis

To assess the prevalence of vesico-ureteral reflux (VUR) and upper urinary tract damage in women with idiopathic high-pressure detrusor overactivity (IHPDO) and to characterize their bladder function.

Methods

A retrospective chart review of women diagnosed with IHPDO (detrusor pressures > 40 cm H2O during involuntary bladder contractions) from 2007 to 2010 was conducted. Women were assessed for VUR by X-ray voiding cysto-urethrogram. Renal ultrasound or CT urogram, serum BUN/creatinine, and urinalyses were performed if reflux reached the renal pelvices. Cystometric and voiding pressure study data were reviewed for detrusor overactivity pressure and volume, voiding dysfunction, urethral relaxation, compliance, and bladder outlet obstruction.

Results

Sixty-five women were diagnosed with IHPDO, and 50 completed an X-ray voiding cysto-urethrogram. The median (range) detrusor overactivity pressure was 65 (41–251) cm H2O. Four (8.0 %) women had IHPDO; none had upper urinary tract deterioration. The majority of women exhibited urethral relaxation with voiding, impaired compliance, and bladder outlet obstruction.

Conclusions

Women with IHPDO are at risk of low-grade vesico-ureteral reflux. However, most women with IHPDO are likely protected from reflux by intermittent exposure to high detrusor pressures and the ability to decompress the bladder by urethral relaxation.  相似文献   

9.

Background

Detrusor overactivity is one known cause of lower urinary tract symptoms and has been linked to bladder storage symptoms (urgency, frequency, or urge incontinence).

Objective

To determine clinical and urodynamic parameters associated with detrusor overactivity in patients with suspected benign prostatic hyperplasia.

Design, Setting, and Participants

During 1993–2003, urodynamic investigations were performed in patients aged 40 yr or older and with lower urinary tract symptoms, benign prostatic enlargement, and/or suspicion of bladder outlet obstruction (maximum flow rate < 15 ml/s or postvoid residual urine > 50 ml).

Measurements

Detrusor overactivity was defined according to the new International Continence Society classification (2002) as involuntary detrusor contractions during cystometry, which may be spontaneous or provoked, regardless of amplitude. The Schäfer algorithm was used to determine bladder outlet obstruction.

Results

In total, 1418 men were investigated (median age: 63 yr) of whom 864 men (60.9%) had detrusor overactivity. In univariate analysis, men with detrusor overactivity were significantly older, more obstructed, had larger prostates, higher irritative International Prostate Symptoms Score subscores, a lower voiding volume at free uroflowmetry, and a lower bladder capacity at cystometry. The prevalence of detrusor overactivity rose continuously with increasing bladder outlet obstruction grade. Multivariate analysis showed that only age and bladder outlet obstruction grade were independently associated with detrusor overactivity. After age adjustment, the odds ratios of detrusor overactivity compared to Schäfer class 0 were 1.2 for class I, 1.4 for class II, 1.9 for class III, 2.5 for class IV, 3.4 for class V, and 4.7 for class VI.

Conclusions

In patients with clinical benign prostatic hyperplasia, detrusor overactivity is independently associated with age and bladder outlet obstruction. The probability of detrusor overactivity rises with increasing age and bladder outlet obstruction grade.  相似文献   

10.
11.

Context/objective

The distal femur is the primary fracture site in patients with osteoporosis after spinal cord injury (SCI).

Objective

To mathematically compare the compression and shear forces at the distal femur during quadriceps stimulation in the standing, supine, and seated positions. A force analysis across these positions may be a consideration for people with SCI during neuromuscular electrical stimulation of the quadriceps.

Design

A biomechanical model.

Setting

Research laboratory.

Outcome measures

Compression and shear forces from the standing, supine, and seated biomechanical models at the distal femur during constant loads generated by the quadriceps muscles.

Results

The standing model estimated the highest compressive force at 240% body weight and the lowest shear force of 24% body weight at the distal femur compared with the supine and seated models. The supine model yielded a compressive force of 191% body weight with a shear force of 62% body weight at the distal femur. The seated model yielded the lowest compressive force of 139% body weight and the highest shear force of 215% body weight.

Conclusions

When inducing a range of forces in the quadriceps muscles, the seated position yields the highest shear forces and lowest compressive forces when compared with the supine and standing positions. Standing with isometric contractions generates the highest compressive loads and lowest shear forces. Early active resistive standing may provide the most effective means to prevent bone loss after SCI.  相似文献   

12.

Objective:

To determine the incidence and etiology of fever and the risk factors related to fever in adults with spinal cord injury (SCI) at the rehabilitation stage.

Design/Subjects:

A retrospective examination of records of 392 consecutive adult patients with traumatic SCI who received inpatient rehabilitation program.

Setting:

A national rehabilitation center in Turkey.

Outcome Measures:

Incidence and etiology of fever, period of hospitalization (days).

Results:

A total of 187 patients (47.7%) had fever at least once during their rehabilitation program. The most common etiology was urinary tract infection. The rate of fever occurrence was significantly higher in patients with complete SCI (P  =  0.001). In patients with fever, the use of an indwelling catheter was significantly higher compared with clean intermittent catheterization and spontaneous voiding (P  =  0.001). The hospitalization period of patients with fever was significantly longer than that of patients without fever (P  =  0.006).

Conclusions:

A high rate of fever was seen in patients with SCI during rehabilitation. Fever was caused by various infections, of which urinary tract infection was the most common. Patients with motor complete injuries and those with permanent catheters constituted higher risk groups. Fever prolonged the length of rehabilitation stay and hindered active participation in the rehabilitation program.  相似文献   

13.

Introduction

Non-neurogenic detrusor overactivity in children leads to varying degrees of functional impairments (urinary urgency, pollakiuria, urge incontinence, nocturia). Botulinum toxin has shown its effectiveness in the management of detrusor overactivity in neurological patients.

Objectives

To evaluate the relevance of intravesical Botulinum toxin injections for the treatment of non-neurogenic overactive bladders in children. These pediatric patients were resistant to all the usual therapeutics (e.g. bladder/bowel rehabilitation, anticholinergic drugs, management of diet/hygiene habits and constipation, percutaneous posterior tibial nerve stimulation).

Materials and methods

8 children (mean age: 12.5 years), 5 girls, 3 boys with daytime and/or nighttime incontinence and non-neurogenic detrusor overactivity validated by urodynamic testing. Urodynamic testing was conducted before the injections as well as 6 weeks and 1 year post injections. We used Dysport® 8 Speywood Units/kg injected via cystoscopy into 25 different sites.

Results

We noted improvements without any complaints during bladder voiding for all patients, in 6 patients the overactivity disappeared after 1 injection. Compliance was improved early-on in half the cases and at 1 year for all cases (from 12% to 61%, p = 0.01). Noninhibited contractions decreased constantly in both frequency and intensity. Clinical symptoms improved: mean of 7.75 daytime urinary incontinence episodes (IE) per week before the injection vs. 3 after the procedure (p = 0.04). For nighttime IE the improvement was even more noticeable with 7.38 nighttime IE episodes per week before the injection vs. 2.06 after the procedure (p = 0,02).

Conclusion

Intradetrusor Botulinum toxin injections are a potential therapeutic option for the management of non-neurogenic detrusor overactivity in children resistant to the usual treatments.  相似文献   

14.

Context

Despite evidence that healthcare providers have implicit biases that can impact clinical interactions and decisions, implicit bias among physicians caring for individuals with spinal cord injury (SCI) has not been examined.

Objective

Conduct a pilot study to examine implicit racial bias of SCI physicians and its association with functioning and wellbeing for individuals with SCI.

Design

Combined data from cross-sectional surveys of individuals with SCI and their SCI physicians.

Setting

Four national SCI Model Systems sites.

Participants

Individuals with SCI (N = 162) and their SCI physicians (N = 14).

Outcome measures

SCI physicians completed online surveys measuring implicit racial (pro-white/anti-black) bias. Individuals with SCI completed questionnaires assessing mobility, physical independence, occupational functioning, social integration, self-reported health, depression, and life satisfaction. We used multilevel regression analyses to examine the associations of physician bias and outcomes of individuals with SCI.

Results

Physicians had a mean bias score of 0.62 (SD = 0.35), indicating a strong pro-white/anti-black bias. Greater physician bias was associated with disability among individuals with SCI in the domain of social integration (odds ratio = 4.80, 95% confidence interval (CI) = 1.44, 16.04), as well as higher depression (B = 3.24, 95% CI = 1.06, 5.41) and lower life satisfaction (B = −4.54, 95% CI= −8.79, −0.28).

Conclusion

This pilot study indicates that SCI providers are susceptible to implicit racial bias and provides preliminary evidence that greater implicit racial bias of physicians is associated with poorer psychosocial health outcomes for individuals with SCI. It demonstrates the feasibility of studying implicit bias among SCI providers and provides guidance for future research on physician bias and patient outcomes.  相似文献   

15.

Background

Although social support is an important protective factor for individuals with spinal cord injuries (SCIs), individuals often encounter significant barriers to obtaining support after experiencing a SCI. It has been suggested that the Internet may serve to help individuals with disabilities overcome common barriers in obtaining support, yet research examining the efficacy of Internet-based support for individuals with SCI has been mixed.

Objective

To develop a more nuanced understanding of how individuals with SCI can or might use the Internet for support.

Design

Using an ethnographic approach, we conducted semi-structured interviews with nine individuals with SCI to explore perceived needs and barriers to information-seeking and online support.

Setting

Participants were recruited from Veterans Administration medical center outpatient and inpatient units providing specialty care to individuals with SCIs and from a community SCI Center of Excellence.

Results

Individuals with SCI gain emotional, problem-focused, and reciprocal support from online sources.

Conclusions

Online resources can provide important opportunities for social support for individuals with SCI.  相似文献   

16.

Context/objective

Pressure ulcers (PrUs) are a serious, costly and potentially life-long complication of spinal cord injury (SCI). Co-morbid conditions increase PrU risk, adding to the health behavior challenges faced by people with SCI. Little is known about medical co-morbidities, health beliefs, risk, protective behaviors, and readiness to improve skin care behaviors in people with SCI. This study describes the potentially modifiable medical and behavioral risk factors among veterans with SCI and severe (Stage III/IV) PrUs.

Design

Cross-sectional observational design.

Setting

6 VA SCI Centers.

Participants

Convenience sample from a larger intervention study of 148 veterans hospitalized for PrUs.

Interventions

Not applicable.

Outcome measures

Knowledge, PrU risk, skin protective behaviors, health beliefs, and practices, health locus of control, skin worsening.

Results

Most ulcers were stage IV (73%) and about half had 2+ PrUs. Participants reported a mean of 6.7 co-morbid conditions (respiratory, gastrointestinal, renal disease/urinary tract infection, autonomic dysreflexia, diabetes, bowel/bladder incontinence). Potential intervention opportunities include proactive assistance with management of multiple chronic conditions, substance abuse, nutrition, adherence to skin protective behaviors, readiness to change, and access to resources. Overall knowledge about PrUs was low, especially for how to prevent PrUs and what to do if skin breakdown occurs.

Conclusion

Future research should address whether comprehensive models that include patient self-management, decision support and health care system, and proactive behavior change assistance for patients help reduce PrU incidence and recurrence in persons with SCI.

Trial Registration

http://clinicaltrials.gov/ct2/show/NCT00105859  相似文献   

17.

Objective:

To examine position-dependent (semireclined to standing) and walking speed–dependent soleus H-reflex modulation after motor incomplete spinal cord injury (SCI).

Participants:

Twenty-six patients with motor incomplete SCI (mean: 45 ± 15 years) and 16 noninjured people (mean: 38 ± 14 years).

Methods:

Soleus H-reflexes were evoked by tibial nerve stimulation. Patients were tested in semireclined and standing positions (experiment 1) and in midstance and midswing positions (experiment 2).

Results:

H-reflexes were significantly greater after SCI in all positions compared with noninjured people (P < 0.05). Position-dependent modulation from semireclined to standing (normally observed in noninjured people) was absent after SCI. In SCI patients, H-reflex modulation was not significantly different at 1.2 m/s compared with 0.6 m/s treadmill walking speed; in noninjured people, H-reflex modulation was significantly greater at 1.2 m/s compared with 0.6 m/s treadmill walking speed. There was a significant positive correlation between modified Ashworth scores, a clinical measure of spasticity and soleus H-reflex amplitudes tested in all positions. A significant negative correlation was also found between H-reflexes in standing and midstance positions and the amount of assistance patients required to walk.

Conclusions:

An improvement in position-dependent and walking speed–dependent reflex modulation after SCI may indicate functional recovery. Future studies will use H-reflex testing to track changes as a result of therapeutic interventions.  相似文献   

18.

Background

Peripheral nerve transfers are being used to improve upper extremity function in cervical spinal cord injury (SCI) patients. The purpose of this study was to evaluate feasibility and perioperative complications following these procedures.

Methods

Eligible SCI patients with upper extremity dysfunction were assessed and followed for a minimum of 3 months after surgery. Data regarding demographics, medical history, physical examination, electrodiagnostic testing, intraoperative nerve stimulation, recipient nerve histomorphometry, surgical procedure, and complications were collected.

Results

Seven patients had surgery on eight limbs, mean age of 28 ± 9.9 years and mean time from SCI injury of 5.1 ± 5.2 years. All patients had volitional elbow flexion and no volitional hand function. The nerve to the brachialis muscle was used as the expendable donor, and the recipients included the anterior interosseous nerve (AIN) (for volitional prehension), nerve branches to the flexor carpi radialis, and flexor digitorum superficialis. Two patients underwent additional nerve transfers: (1) supinator to extensor carpi ulnaris or (2) deltoid to triceps. No patients had any loss of baseline upper extremity function, seven of eight AIN nerve specimens had preserved micro-architecture, and all intraoperative stimulation of recipient neuromuscular units was successful further supporting feasibility. Four patients had perioperative complications; all resolved or improved (paresthesias).

Conclusion

Nerve transfers can be used to reestablish volitional control of hand function in SCI. This surgery does not downgrade existing function, uses expendable donor nerve, and has no postoperative immobilization, which might make it a more viable option than traditional tendon transfer and other procedures.  相似文献   

19.

Background

Sedentarism is common among people with spinal cord injury (SCI). However, new technologies such as functional electrical stimulation cycles with internet connectivity may provide incentive by removing some of the limitations and external barriers.

Objective

To determine the effectiveness of a long-term home-based functional electrical stimulation lower extremities cycling (FES-LEC) program on exercise adherence, body composition, energy expenditure, and quality of life (QOL) in an adult with chronic tetraplegia.

Participant

A 53-year-old man, 33 years post-motor complete C4 SCI participated in FES-LEC in his home, three sessions per week for 24 weeks.

Methods

Exercise adherence was calculated as the percentage of performed cycling sessions relative to the recommended number of cycling sessions. Body composition was measured by dual-energy X-ray absorptiometry. Energy expenditure was measured using a COSMED K4b2 and QOL via the World Health Organization Quality of Life (WHO-QOL) Brief Questionnaire. Testing was performed before and after the 24-week exercise program.

Results

The participant cycled 59 out of a recommended 72 sessions which is an exercise adherence rate of 82%. Body composition displayed increases in total body lean mass (LM) with an increase of 3.3% and an increase in leg LM of 7.1%. Energy expenditure increased by 1.26 kcal/minute or greater than 200%. The physical and psychological domain scores of QOL increased by 25 and 4.5%, respectively.

Conclusion

This case study provides encouragement concerning the practicality of a home-based FES-LEC program for those with SCI.  相似文献   

20.

Context/objective

We describe the rationale, design, methods, and lessons learned conducting a treatment trial for major depressive disorder (MDD) or dysthymia in people with spinal cord injury (SCI).

Design

A multi-site, double-blind, randomized (1:1) placebo controlled trial of venlafaxine XR for MDD or dysthymia. Subjects were block randomized and stratified by site, lifetime history of substance dependence, and prior history of MDD.

Setting

Six SCI centers throughout the United States.

Participants

Across participating centers, 2536 subjects were screened and 133 were enrolled into the trial. Subjects were 18–64 years old and at least 1 month post-SCI.

Interventions

Twelve-week trial of venlafaxine XR versus placebo using a flexible titration schedule.

Outcome measures

The primary outcome was improvement in depression severity at 12 weeks. The secondary outcome was improvement in pain.

Results

This article includes study methods, modifications prompted by a formative review process, preliminary data on the study sample and lessons learned. We describe common methodological and operational challenges conducting multi-site trials and how we addressed them. Challenges included study organization and decision making, staff training, obtaining human subjects approval, standardization of measurement and treatment, data and safety monitoring, subject screening and recruitment, unblinding and continuity of care, database management, and data analysis.

Conclusions

The methodological and operational challenges we faced and the lessons we learned may provide useful information for researchers who aim to conduct clinical trials, especially in the area of medical treatment of depression in people with SCI.  相似文献   

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