Effect of Aqua Therapy Exercises on Postmastectomy Lymphedema: A Prospective Randomized Controlled Trial.
Ontology highlight
ABSTRACT: Objective
To investigate the effect of aqua therapy resistance exercise on arm volume, pain, and shoulder range of movements in post-mastectomy lymphedema.Methods
This was a single-blind randomized controlled trial. Fifty eligible breast cancer survivors (median, 10 years after surgery) with lymphedema (median, 21% inter-limb difference) were assigned randomly to group A (n=25) or control group B (n=25). The study group underwent 60 minutes of aqua therapy exercise comprising of warm-up for 10 minutes, 40 minutes of strengthening exercises, and 10 minutes of cooling down, three times a week for 8 weeks. The control group underwent 60 minutes of land-based exercise three times a week for 8 weeks. Arm volume calculated by measuring the arm circumference, shoulder flexion, and abduction range of motion (ROM), and pain using a visual analog scale (VAS) were assessed at baseline and after 8 weeks of treatment.Results
There was a statistically significant difference in limb volume, shoulder flexion and abduction ROM, and VAS scores in favor of the study group (p<0.001) after 8 weeks of intervention. The mean±standard deviation for limb volume, shoulder flexion, abduction, and pain score were 2,108.71±200.97 mL, 169.68°±4.54°, 150.44°±3.92°, and 3.16±1.1 in the study group and 2,256.41±186.94 mL, 147.36°±5.32°, 131.32°±4.38°, and 5.68±0.94 in the control group, respectively.Conclusion
Adding aqua therapy resistance exercise to routine physical therapy might be more effective in decreasing the limb volume and pain intensity and improving ROM of the shoulder in postmastectomy lymphedema.
SUBMITTER: Ali KM
PROVIDER: S-EPMC8137385 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:Background: Low back pain (LBP) is the first cause of years lived with disability worldwide. This is due to the development of chronic pain. Thus, it is necessary to identify the best therapeutic approaches in the acute phase of LBP to limit the transition to chronic pain. Superficial heat presents the highest level of evidence for short-term reduction in pain and disability in acute LBP. Physical activity is also recommended to avoid transition to chronic LBP, but there is a lack of evidence to determine its effect to reduce acute LBP. Also, the long-term effects of these interventions are unknown. This is a protocol for a randomized controlled trial (RCT) to determine the short and long-term effects of wearable continuous low-level thermal therapy, in combination with exercises or not, on disability and pain.Methods/design: Sixty-nine participants with acute LBP will be randomly assigned to one of three intervention programs: 1) thermal therapy, 2) thermal therapy + exercises, and 3) control. The interventions will be applied for 7 continuous days. The primary outcome will be disability and secondary outcomes will be pain intensity, pain-related fear, self-efficacy, number of steps walked and perception of change. The evaluators will be blinded to the interventions, and participants will be blinded to other groups' interventions. Primary and secondary outcomes will be compared between intervention groups.Discussion: This study will provide new evidence about acute LBP treatments, to limit transition to chronicity. This will be the first study to measure the long-term effects of wearable continuous low-level thermal therapy, combined or not to exercises.Trial registration: This RCT has been retrospectively registered on ClinicalTrials.gov ( NCT03986047 ) on June 14th, 2019.
| S-EPMC7719244 | biostudies-literature
Project description:PURPOSE:Approximately 20% of breast cancer survivors develop breast cancer-related lymphedema (BCRL), and current therapies are limited. We compared acupuncture (AC) to usual care wait-list control (WL) for treatment of persistent BCRL. METHODS:Women with moderate BCRL lasting greater than six months were randomized to AC or WL. AC included twice weekly manual acupuncture over six weeks. We evaluated the difference in circumference and bioimpedance between affected and unaffected arms. Responders were defined as having a decrease in arm circumference difference greater than 30% from baseline. We used analysis of covariance for circumference and bioimpedance measurements and Fisher's exact to determine the proportion of responders. RESULTS:Among 82 patients, 73 (89%) were evaluable for the primary endpoint (36 in AC, 37 in WL). 79 (96%) patients received lymphedema treatment before enrolling in our study; 67 (82%) underwent ongoing treatment during the trial. We found no significant difference between groups for arm circumference difference (0.38 cm greater reduction in AC vs. WL, 95% CI - 0.12 to 0.89, p?=?0.14) or bioimpedance difference (1.06 greater reduction in AC vs. WL, 95% CI - 5.72 to 7.85, p?=?0.8). There was also no difference in the proportion of responders: 17% AC versus 11% WL (6% difference, 95% CI - 10 to 22%, p?=?0.5). No severe adverse events were reported. CONCLUSIONS:Our acupuncture protocol appeared to be safe and well tolerated. However, it did not significantly reduce BCRL in pretreated patients receiving concurrent lymphedema treatment. This regimen does not improve upon conventional lymphedema treatment for breast cancer survivors with persistent BCRL.
| S-EPMC6159216 | biostudies-literature
Project description:PurposeHypofractionation in the setting of postmastectomy radiation (PMRT) is not currently the standard of care in most countries. Here we present a 5-year update of our multi-institutional, phase 2 prospective trial evaluating a novel 15-day hypofractionated PMRT regimen.Methods and materialsPatients were enrolled to receive 3.33 Gy daily to the chest wall (or reconstructed breast) and regional lymphatics in 11 fractions with an optional 4-fraction mastectomy scar boost. The primary endpoint was freedom from grade 3 or higher late non-reconstruction-related radiation toxicities. Toxicities were scored using Common Terminology Criteria for Adverse Events v4.0. Secondary endpoints included local and locoregional recurrence rates, cosmesis, and reconstruction complications.ResultsAfter enrolling 69 patients with stage II-IIIa breast cancer, 67 women were eligible for analysis. At a median follow up of 54 months, there were no acute or late grade 3 and 4 nonreconstruction reported toxicities. The grade 2 or greater late toxicity rate was only 12% and comprised grade 2 pain, fatigue, and lymphedema that persisted beyond 6 months after completion of radiation therapy. Only 3 women (4.6%) experienced a chest wall or nodal recurrence as a first site of relapse. Freedom from local failure, including local failure after distant relapse, was 92% at 5 years, and the 5-year overall survival was 90%.ConclusionsThis is the first prospective trial conducted in the United States to demonstrate the safe and effective use of hypofractionated PMRT. We have demonstrated a low complication rate while achieving excellent local control. Toxicity was better than anticipated based on previously published series of PMRT toxicities. Although our fractionation was novel, the radiobiological equivalent dose is similar to other hypofractionation schedules. This trial was the basis for the creation of Alliance A221505 (RT CHARM), which is currently accruing patients in a phase 3 randomized design.
| S-EPMC7373304 | biostudies-literature
Project description:BackgroundVarious exercises have been proposed to mitigate chronic low back pain (LBP). However, to date, no one particular exercise has been shown to be superior. Hence, the aim of this study was to compare the efficiency between 2 exercises: the individualized graded lumbar stabilization exercise (IGLSE) and walking exercise (WE).MethodsA randomized controlled trial was conducted in 48 participants with chronic LBP. After screening, participants were randomized to 1 of 4 groups: flexibility exercise, WE, stabilization exercise (SE), and stabilization with WE (SWE) groups. Participants underwent each exercise for 6 weeks. The primary outcome was visual analog scale (VAS) of LBP during rest and physical activity. Secondary outcomes were as follows: VAS of radiating pain measured during rest and physical activity; frequency of medication use (number of times/day); Oswestry disability index; Beck depression inventory; endurances of specific posture; and strength of lumbar extensor muscles.ResultsLBP during physical activity was significantly decreased in all 4 groups. Exercise frequency was significantly increased in the SE and WE groups; exercise time was significantly increased in the SE group. The endurance of supine, side lying, and prone posture were significantly improved in the WE and SWE groups.ConclusionsLumbar SE and WE can be recommended for patients with chronic LBP because they not only relieve back pain but also prevent chronic back pain through improving muscle endurance.
| S-EPMC6616307 | biostudies-literature
Project description:Physical therapy treatment of patients with lymphedema includes treatment based on the principles of 'Complete Decongestive Therapy' (CDT). CDT consists of the following components; skin care, manual lymphatic drainage, bandaging and exercises. The scientific evidence regarding what type of treatment is most effective is sparse. The objective of this study is to investigate whether CDT is equally effective if it includes manual lymphatic drainage or not in the treatment of arm lymphedema among patients with breast cancer.A randomized, single-blind, equivalence trial. A total of 160 breast cancer patients with arm lymphedema will be recruited from 3 hospitals and randomized into one of two treatment groups A: Complete Decongestive Therapy including manual drainage or B: Complete Decongestive Therapy without manual lymphatic drainage. The intervention period will be approximately 4 weeks followed by a 6 month follow-up period (7 months from baseline). Primary outcome variable: the percentage volume reduction of lymphedema (%) from baseline to 7 months. Secondary outcome variables: Differences from baseline to week 4 and from week 4 to month 7 in circumference of the arm (cm), body weight (kg), patient sensation of heaviness (scale range: 0-10), patient sensation of tension (scale range: 0-10), and quality of life (EQ-5D-5 L-questionnaire).All measurements are standardized and will be performed before randomization, after 4 weeks and after 7 months.This randomized controlled study seeks to provide data on an effective treatment for patients with breast cancer related arm lymphedema and which at the same time causes minimal patient inconvenience.ClinicalTrials.gov: Identifier NCT02015897.
| S-EPMC3978135 | biostudies-literature
Project description:Purpose Conventionally fractionated postmastectomy radiation therapy (PMRT) takes approximately 5 to 6 weeks. Data supporting hypofractionated PMRT is limited. We prospectively evaluated a short course of hypofractionated PMRT, in which therapy was completed in 15 treatment days. Patients and Methods We delivered PMRT at a dose of 36.63 Gy in 11 fractions of 3.33 Gy over 11 days to the chest wall and the draining regional lymph nodes, followed by an optional mastectomy scar boost of four fractions of 3.33 Gy. Our primary end point was freedom from any grade 3 or higher toxicities. We incorporated early stopping criteria on the basis of predefined toxicity thresholds. Results We enrolled 69 women with stage II to IIIa breast cancer, of whom 67 were eligible for analysis. After a median follow-up of 32 months, there were no grade 3 toxicities. There were 29 reported grade 2 toxicities, with grade 2 skin toxicities being the most frequent (16 of 67; 24%). There were two patients with isolated ipsilateral chest wall tumor recurrences (2 of 67; crude rate, 3%). Three-year estimated local recurrence-free survival was 89.2% (95% CI, 0.748 to 0.956). The 3-year estimated distant recurrence-free survival was 90.3% (95% CI, 0.797 to 0.956). Forty-one patients had chest wall reconstructions; three had expanders removed for infection before radiation therapy. The total rate of implant loss or failure was 24% (9 of 38), and the unplanned surgical correction rate was 8% (3 of 38), for a total complication rate of 32%. Conclusion To our knowledge, our phase II prospective study offers one of the shortest courses of PMRT reported, delivered in 11 fractions to the chest wall and nodes and 15 fractions inclusive of a boost. We demonstrated low toxicity and high local control with this schedule. On the basis of our data, we have designed a cooperative group phase III prospective, randomized trial of conventional versus hypofractionated PMRT that will activate soon.
| S-EPMC5476174 | biostudies-literature
Project description:Rationale: Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard carbohydrate-based nutritional regimes. We therefore hypothesize that a ketogenic diet improves sepsis treatment. Objectives: We investigated the safety and feasibility of a ketogenic diet in sepsis patients. Methods: We conducted a monocentric open-labeled randomized controlled trial (DRKS00017710) enrolling adult sepsis patients randomly assigned to either ketogenic or standard high-carbohydrate diet for 14 days with follow-up until day 30. The primary outcome measure was β-hydroxybutyrate serum concentration on day 14. Secondary outcomes included safety, clinical and immunological changes. Measurements and Main Results: 40 critically ill septic patients were assigned to the study groups. Increase in β-hydroxybutyrate concentrations from baseline to day 14 was markedly greater under ketogenic diet (1.2 ±0.9) compared to controls (-0.3 ±0.4); estimated mean difference 1.4 (95%-CI 1.0-1.8; p<0.0001). During ketogenic diet, no patient required insulin treatment beyond day 4, whereas 35% to 60% of control patients did (p=0.0095). Metabolic side effects were not observed under ketogenic diet. Ventilation-free (IRR 1.7; 95%-CI: 1.5 to 2.1; p<0.0001), vasopressor-free (IRR 1.7; 95%-CI: 1.5 to 2.0; p<0.0001), dialysis-free (IRR 1.5; 95%-CI: 1.3 to 1.8; p<0.0001), and ICU-free days (IRR 1.7; 95%-CI: 1.4 to 2.1; p<0.0001) significantly increased in patients under ketogenic diet. There was no difference in 30-day mortality. Analyses indicated favorable changes towards immune homeostasis. Conclusions: Ketogenic diet is a feasible and safe nutritional regimen in septic patients promoting recovery from sepsis-related organ dysfunction and could become a new tool in modern treatment concepts.
2024-06-13 | PXD046061 | Pride
Project description:A strong and growing body of evidence has demonstrated the effectiveness of cognitive behavioral therapy (CBT), either face-to-face, in person, or as self-help via the Internet, for depression. However, CBT is a complex intervention consisting of several putatively effective components, and how each component may or may not contribute to the overall effectiveness of CBT is poorly understood.The aim of this study was to investigate how the users of smartphone CBT use and benefit from various components of the program.This is a secondary analysis from a 9-week, single-blind, randomized controlled trial that has demonstrated the effectiveness of adjunctive use of smartphone CBT (Kokoro-App) over antidepressant pharmacotherapy alone among patients with drug-resistant major depressive disorder (total n=164, standardized mean difference in depression severity at week 9=0.40, J Med Internet Res). Kokoro-App consists of three cognitive behavioral skills of self-monitoring, behavioral activation, and cognitive restructuring, with corresponding worksheets to fill in. All activities of the participants learning each session of the program and completing each worksheet were uploaded onto Kokoro-Web, which each patient could use for self-check. We examined what use characteristics differentiated the more successful users of the CBT app from the less successful ones, split at the median of change in depression severity.A total of 81 patients with major depression were allocated to the smartphone CBT. On average, they completed 7.0 (standard deviation [SD] 1.4) out of 8 sessions of the program; it took them 10.8 (SD 4.2) days to complete one session, during which they spent 62 min (SD 96) on the app. There were no statistically significant differences in the number of sessions completed, time spent for the program, or the number of completed self-monitoring worksheets between the beneficiaries and the nonbeneficiaries. However, the former completed more behavioral activation tasks, engaged in different types of activities, and also filled in more cognitive restructuring worksheets than the latter. Activities such as "test-drive a new car," "go to a coffee shop after lunch," or "call up an old friend" were found to be particularly rewarding. All cognitive restructuring strategies were found to significantly decrease the distress level, with "What would be your advice to a friend who has a similar problem?" found more helpful than some other strategies.The CBT program offered via smartphone and connected to the remote server is not only effective in alleviating depression but also opens a new avenue in gathering information of what and how each participant may utilize the program. The activities and strategies found useful in this analysis will provide valuable information in brush-ups of the program itself and of mobile health (mHealth) in general.Japanese Clinical Trials Registry UMIN CTR 000013693; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ ctr_view.cgi?recptno=R000015984 (Archived by WebCite at http://www.webcitation.org/6u6pxVwik).
| S-EPMC5785683 | biostudies-other
Project description:The removal of pre-malignant colorectal lesions prevents cancer. Hyoscine has been proposed as a means of improving diagnosis by reducing colonic movements. The aim of this study was to analyze whether this anti-spasmodic enhances the detection of pre-malignant colorectal lesions.In a randomized, double-blinded fashion patients received hyoscine or a saline solution in all consecutive colonoscopies in which the cecum was reached. Lesions were analysed with respect to number, size, location, histology and capillary pattern.A total of 440 colonoscopies were randomized. The overall polyp detection rate (PDR) and the adenoma detection rate (ADR) were 65.2% and 49.3%, respectively. In the hyoscine group, non-polypoid lesions were detected significantly more often (p=0.01). In the placebo group 281 lesions were diagnosed (202 adenomas) and in the hyoscine group 282 lesions were detected (189 adenomas) (p=0.23). The PDR and ADR were similar between the placebo and hyoscine groups (64% vs 66% and 50% vs 47%, respectively). No differences were observed between the two groups in the advanced-ADR or advanced neoplasia detection rate, as well the mean numbers of polyps, adenomas, advanced adenomas and advanced neoplasias detected per patient. The administration of hyoscine also did not improve the diagnostic accuracy of digital chromoendoscopy. The presence of adenomatous polyps in the right colon was detected significantly more frequently in the hyoscine group (OR 5.41 95% CI 2.7 - 11; p<0.01 vs OR 2.3 95% CI 1.1 - 4.6; p=0.02).The use of hyoscine before beginning the withdrawal of the colonoscope does not seem to enhance the PDR and the ADR.
| S-EPMC5525190 | biostudies-other
Project description:Lymphatic filariasis (LF) is a major cause of lymphedema, affecting over 16 million people globally. A daily, hygiene-centered self-care protocol is recommended and effective in reducing acute attacks caused by secondary infections. It may also reverse lymphedema status in early stages, but less so as lymphedema advances. Lymphatic stimulating activities such as self-massage and deep-breathing have proven beneficial for cancer-related lymphedema, but have not been tested in LF-settings. Therefore, an enhanced self-care protocol was trialed among people affected by moderate to severe LF-related lymphedema in northern Bangladesh. Cluster randomization was used to allocate participants to either standard- or enhanced-self-care groups. Lymphedema status was determined by lymphedema stage, mid-calf circumference, and mid-calf tissue compressibility. There were 71 patients in each group and at 24 weeks, both groups had experienced significant improvement in lymphedema status and reduction in acute attacks. There was a significant and clinically relevant between-group difference in mid-calf tissue compressibility with the biggest change observed on legs affected by severe lymphedema in the enhanced self-care group (∆ 21.5%, -0.68 (-0.91, -0.45), p < 0.001). This study offers the first evidence for including lymphatic stimulating activities in recommended self-care for people affected by moderate and severe LF-related lymphedema.
| S-EPMC7464742 | biostudies-literature