Background: The-Optimal-Lymph-Flow (TOLF) intervention aims to promote lymph flow through therapeutic lymphatic exercises to relieve lymphatic pain, swelling, lymphedema symptoms, and to decrease lymph fluid levels among breast cancer survivors. To enhance the efficacy of the TOLF intervention, an innovative, intelligent, Kinect-enhanced lymphatic exercise intervention (Kinect-TOLF) was developed to teach patients to perform the lymphatic exercises correctly. Objectives: This feasibility trial aimed to determine the feasibility, usability, and effects of the Kinect-TOLF on lymphatic pain, swelling, lymphedema symptoms, and lymph fluid levels. Methods: A single-arm feasibility trial with a pre- and post-test design was employed to recruit 30 breast cancer survivors with persistent lymphatic pain or swelling. Patients received a single training session to learn how to perform the lymphatic exercises using the Kinect-TOLF program. Descriptive statistics, Wilcoxon signed-rank tests, t-test, Spearman’s rank correlation coefficients, linear regressions, and Cohen’s d were performed for data analysis. Qualitative data were assessed for common themes. Results: The Kinect-TOLF was effective in training patients to perform the lymphatic exercises correctly with high user satisfaction. Significant reductions were found in scores of lymphatic pain ( MedΔ = −1.00, CI = [−1.5, −0.1], P = .004), arm/hand swelling ( MedΔ = −1.00, CI = [−1.5, −0.5], P = .004), total swelling ( MedΔ = −1.5, CI = [−2.0, −1.0], P = .003), number of lymphedema symptoms ( MΔ = −3.8, CI = [−5.5, −2.1], P < .001), and lymphedema symptom severity ( MΔ = −5.3, CI = [−9.5, −1.1], P = .016). A significant reduction in lymph fluid levels was found in mean L-Dex scores ( MΔ = −2.68, CI = [−4.67, −0.69], P = .010). Greater decrease in mean L-Dex scores were found in patients with abnormal lymph fluid levels (L-Dex ≥ 7.1) ( MΔ = −5.19, CI = [−1.75, −8.63], P = .008). Patients’ qualitative feedback supported the results of the study. Conclusions: The Kinect-TOLF is safe, feasible, and effective in reducing lymphatic pain, swelling, lymphedema symptoms, and in decreasing lymph fluid levels. Future research should focus on a randomized clinical trial to confirm the unique or synergistic efficacy of the Kinect-TOLF in comparison with current lymphedema treatment and other forms of exercises or movement therapy. This study was registered in ClinicalTrials.gov with US ClinicalTrials.gov Identifier: NCT03999177.
Background The-Optimal-Lymph-Flow (TOLF) is a patient-centered, web- and mobile-based mHealth system that delivers safe, easy, and feasible digital therapy of lymphatic exercises and limb mobility exercises. Objective The purpose of this randomized clinical trial (RCT) was to evaluate the effectiveness of the web- and mobile-based TOLF system for managing chronic pain and symptoms related to lymphedema. The primary outcome includes pain reduction, and the secondary outcomes focus on symptom relief, limb volume difference measured by infrared perometer, BMI, and quality of life (QOL) related to pain. We hypothesized that participants in the intervention group would have improved pain and symptom experiences, limb volume difference, BMI, and QOL. Methods A parallel RCT with a control–experimental, pre- and posttest, and repeated-measures design were used. A total of 120 patients were recruited face-to-face at the point of care during clinical visits. Patients were randomized according to pain in a 1:1 ratio into either the arm precaution (AP) control group to improve limb mobility and arm protection or The-Optimal-Lymph flow (TOLF) intervention group to promote lymph flow and limb mobility. Trial outcomes were evaluated at baseline and at week 12 after the intervention. Descriptive statistics, Fisher exact tests, Wilcoxon rank-sum tests, t test, and generalized linear mixed effects models were performed for data analysis. Results At the study endpoint of 12 weeks, significantly fewer patients in the TOLF intervention group compared with the AP control group reported chronic pain (45% [27/60] vs 70% [42/60]; odds ratio [OR] 0.39, 95% CI 0.17-0.90; P=.02). Patients who received the TOLF intervention were significantly more likely to achieve a complete reduction in pain (50% [23/46] vs 22% [11/51]; OR 3.56, 95% CI 1.39-9.76; P=.005) and soreness (43% [21/49] vs 22% [11/51]; OR 2.60, 95% CI 1.03-6.81; P=.03). Significantly lower median severity scores were found in the TOLF group for chronic pain (MedTOLF=0, IQR 0-1 vs MedAP=1, IQR 0-2; P=.02) and general bodily pain (MedTOLF=1, IQR=0-1.5 vs MedAP=1, IQR 1-3; P=.04). Compared with the AP control group, significantly fewer patients in the TOLF group reported arm/hand swelling (P=.04), heaviness (P=.03), redness (P=.03), and limited movement in shoulder (P=.02) and arm (P=.03). No significant differences between the TOLF and AP groups were found in complete reduction of aching (P=.12) and tenderness (P=.65), mean numbers of lymphedema symptom reported (P=.11), ≥5% limb volume differences (P=.48), and BMI (P=.12). Conclusions The TOLF intervention had significant benefits for breast cancer survivors to manage chronic pain, soreness, general bodily pain, arm/hand swelling, heaviness, and impaired limb mobility. The intervention resulted in a 13% reduction (from 40% [24/60] to 27% [16/60]) in proportions of patients who took pain medications compared with the AP control group, which had a 5% increase (from 40% [24/60] to 45% [27/60]). A 12% reduction (from 27% [16/60] to 15% [9/60]) in proportions of patients with ≥5% limb volume differences was found in the TOLF intervention, while a 5% increase in the AP control group (from 40% [24/60] to 45% [27/60]) was found. In conclusion, the TOLF intervention can be a better choice for breast cancer survivors to reduce chronic pain and limb volume. Trial Registration Clinicaltrials.gov NCT02462226; https://clinicaltrials.gov/ct2/show/NCT02462226 International Registered Report Identifier (IRRID) RR2-10.2196/resprot.5104
Background Increasingly more nonbinary patients are obtaining better access for gender-affirming chest surgery (top surgery), representing an important subset of patients who undergo such surgery. Objective We review our experience at gender-affirming chest surgery in nonbinary versus transmasculine patients in an integrated health care setting. Methods We performed a retrospective study of nonbinary and transmasculine patients who underwent gender-affirming chest surgery from May 1, 2012, to December 27, 2017. Results There were 111 nonbinary patients and 665 transmasculine patients included in the final analyses. Nonbinary patients were more likely to seek more than 1 surgical consultations than transmasculine patients (24.3% vs 1.7%, respectively, P < 0.0001). More nonbinary patients (17.3%) indicated nipple sensation to be important relative to their transmasculine counterparts (0.4%, P < 0.0001). Fewer nonbinary patients were on testosterone before surgery (33.64%) in comparison to transmasculine patients (86.14%, P < 0.0001). When only prior reduction mammaplasty or top surgery were considered, nonbinary patients (8.1%) were more likely than transmasculine patients (3.5%) to have had a prior chest surgery. When evaluating patients who did not have prior chest surgery before undergoing top surgery at our institution (n = 721), rates of major complications, minor complications, as well as revisions, were comparable between nonbinary and transmasculine patients. Conclusions This study demonstrated that more nonbinary patients requested nonflat chests relative to their transmasculine counterparts. Both groups in our sample displayed comparable rates of complications after top surgery.
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