Results of a Pilot Trial of a Lifestyle Intervention for Stroke Survivors: Healthy Eating and Lifestyle after Stroke.

OBJECTIVES: Although healthy lifestyle practices mitigate recurrent stroke risk and mortality, few stroke survivors adhere to them, particularly among socioeconomically disadvantaged communities. We developed and pilot tested a occupational therapy-based lifestyle management intervention, Healthy Eating And Lifestyle after Stroke (HEALS), to improve stroke survivors' self-management skills relating to diet and physical activity and evaluated it in a diverse safety-net population. MATERIALS AND METHODS: One hundred English- or Spanish-speaking participants with stroke or transient ischemic attack were randomized to a 6-week occupational therapist-led group lifestyle intervention vs. usual care. Each of the six 2-h group sessions included didactic presentations on diet and physical activity, peer exchange, personal exploration with goal setting, and direct experience through participation in a relevant activity. Primary outcomes at 6 months were change in body mass index, fruit/vegetable intake, and physical activity. Secondary outcomes included change in waist circumference, smoking, blood pressure, high-density lipoprotein, low-density lipoprotein, triglyceride, total cholesterol, glycosylated hemoglobin levels, quality of care, and perceptions of care. Effect sizes were determined in preparation for a larger randomized controlled trial powered to detect a difference in primary outcomes. A nested formative evaluation assessed facilitators and barriers to implementation, acceptance, and intervention adherence. RESULTS: There were no significant changes in primary or secondary outcomes at 6 months. Effect sizes for all outcomes were small (< 0.2). Focus group participants recommended extending the intervention program duration with more sessions, additional information on stroke and vascular risk factors, an interdisciplinary approach, additional family involvement, and incentives. Providers recommended longer program duration, more training, fidelity checks to ensure standardized program delivery, and additional incentives for participants. CONCLUSIONS: The HEALS intervention was feasible in a safety-net setting, but effect sizes were small. A longer-duration intervention, with intervener fidelity checks may be warranted. TRIAL REGISTRATION: NCT01550822.

A Pilot Trial of a Lifestyle Intervention for Stroke Survivors: Design of Healthy Eating and Lifestyle after Stroke (HEALS).

BACKGROUND: Stroke survivors have high rates of subsequent cardiovascular and recurrent cerebrovascular events, and mortality. While healthy lifestyle practices - including a diet rich in fruits and vegetables, limited alcohol intake, and regular physical activity - can mitigate these outcomes, few stroke survivors adhere to them. Minorities from socioeconomically disadvantaged communities who obtain care in safety-net health systems experience the most barriers to implementing healthy lifestyle changes after stroke. PURPOSE: To report the design of Healthy Eating and Lifestyle After Stroke (HEALS), a randomized controlled trial (RCT) was designed to test the feasibility of using a manualized, lifestyle management intervention in a safety-net setting to improve lifestyle practices among ethnically diverse individuals with stroke or transient ischemic attack (TIA). METHODS: Design: Pilot RCT. PARTICIPANTS: Inclusion criteria: 1) Adults (≥40 years) with ischemic stroke or TIA (≥ 90 days prior); 2) English- or Spanish-speaking. SETTING: Outpatient clinic, safety-net setting. INTERVENTION: Weekly two-hour small group sessions led by an occupational therapist for six weeks. The sessions focused on implementing nutrition, physical activity, and self-management strategies tailored to each participant's goals. MAIN OUTCOME MEASURES: Body mass index, diet, and physical activity. CONCLUSIONS: Recruitment for this study is complete. If the HEALS intervention study is feasible and effective, it will serve as a platform for a large-scale RCT that will investigate the efficacy and cost-effectiveness of life management interventions for racially and ethnically diverse, low-income individuals with a history of stroke or TIA who seek healthcare in the safety-net system.

Strabismus after deep lateral wall orbital decompression in thyroid-related orbitopathy patients using automated hess screen.

PURPOSE: To evaluate the effect of deep lateral wall orbital decompression with intraconal fat debulking on strabismus in thyroid-related orbitopathy (TRO) patients using automated Hess screen (AHS). DESIGN: Prospective nonrandomized clinical study. PARTICIPANTS: Eleven TRO patients (19 surgeries) operated on at the Jules Stein Eye Institute from January, 2004, through December, 2004. METHODS: Automated Hess screen testing was performed in all patients before surgery and 3 months after surgery; all patients received surgery in the nonactive phase of the disease. MAIN OUTCOME MEASURES: Amplitude of horizontal and vertical deviations (prism diopters) in all standard positions of gaze. RESULTS: Eleven TRO patients (7 females; mean age, 47 years) were included in the study; 8 patients underwent bilateral surgery. After surgery, exophthalmos decreased an average (+/-standard deviation) of 2.7 mm (+/-2.5 mm; P = 0.003). Before surgery, 7 patients (63%) reported primary gaze diplopia, whereas only 2 patients (18%) showed diplopia in primary gaze after surgery (P = 0.03, chi-square analysis). Orbital decompression had no statistically significant effect on horizontal and vertical ocular deviations measured by AHS. Mean amplitude of deviation in primary gaze was 1.2 prism diopters (PD) esotropia and 0.07 PD hypotropia before surgery, and 2.5 PD exotropia with 0.6 PD hypertropia after surgery (delta = 3.7 PD for horizontal deviation and -0.7 for vertical deviation; P = 0.051, paired samples t test for horizontal difference and P not significant for vertical difference). Nonsignificant P values were obtained in all 9 positions of gaze. Most patients had periocular numbness that resolved spontaneously 2 to 6 months after surgery. CONCLUSIONS: Deep lateral wall orbital decompression with intraconal fat debulking had no statistically significant effect on horizontal and vertical deviations measured by the AHS. Patients may demonstrate small angle exotropia shift, but this finding was not clinically significant.

Frontalis suspension for upper eyelid ptosis: evaluation of different surgical designs and suture material.

PURPOSE: To compare two sling designs (single loop or double pentagon) and a variety of suture material that was used in frontalis suspension surgery for correction of upper eyelid ptosis. DESIGN: Retrospective, nonrandomized, comparative interventional case series. METHODS: Medical record review of 99 patients (164 surgeries) who underwent frontalis suspension surgery for upper eyelid ptosis was conducted at the Jules Stein Eye Institute in 1996 to 2002. Functional and cosmetic success, margin reflex distance (MRD) and lagophthalmos were evaluated. RESULTS: MRD increased an average of 1.1 mm after the operation (P < .001). Ptosis recurrence was noticed in 42 cases (26%); polytetrafluoroethylene achieved the lowest recurrence rate (15%), although not statistically significant. No difference in functional success, ptosis recurrence, or change in MRD was noticed between single loop and double pentagon design. A better cosmetic outcome was noted in cases in which nylon suture was used. Complications included four cases (2.4%) of over-correction, three cases (1.8%) of suture infection (all in polytetrafluoroethylene), two cases of pyogenic granuloma (1.2%), and two cases (1.2%) of suture exposure. CONCLUSION: Frontalis suspension for upper eyelid ptosis resulted in 26% ptosis recurrence after a mean of 12 months from first surgery. Polytetrafluoroethylene showed the lowest incidence of ptosis recurrence. No statistically significant difference was found between different suture materials or loop shape that was used in the surgical technique. A better cosmetic outcome, as graded by different observers, was noted in cases in which a nylon sling was used.