Effect of physical therapy on breast cancer related lymphedema:protocol for a multicenter, randomized, single-blind, equivalence trial

BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov: Identifier NCT0201589

Influence of frequency and duration of strength training for effective management of neck and shoulder pain:a randomised controlled trial

BACKGROUND: Specific strength training can reduce neck and shoulder pain in office workers, but the optimal combination of exercise frequency and duration remains unknown. This study investigates how one weekly hour of strength training for the neck and shoulder muscles is most effectively distributed. METHODS: A total of 447 office workers with and without neck and/or shoulder pain were randomly allocated at the cluster-level to one of four groups; 1×60 (1WS), 3×20 (3WS) or 9×7 (9WS) min a week of supervised high-intensity strength training for 20 weeks, or to a reference group without training (REF). Primary outcome was self-reported neck and shoulder pain (scale 0–9) and secondary outcome work disability (Disability in Arms, Shoulders and Hands (DASH)). RESULTS: The intention-to-treat analysis showed reduced neck and right shoulder pain in the training groups after 20 weeks compared with REF. Among those with pain ≥3 at baseline (n=256), all three training groups achieved significant reduction in neck pain compared with REF (p<0.01). From a baseline pain rating of 3.2 (SD 2.3) in the neck among neck cases, 1WS experienced a reduction of 1.14 (95% CI 0.17 to 2.10), 3WS 1.88 (0.90 to 2.87) and 9WS 1.35 (0.24 to 2.46) which is considered clinically significant. DASH was reduced in 1WS and 3WS only. CONCLUSION: One hour of specific strength training effectively reduced neck and shoulder pain in office workers. Although the three contrasting training groups showed no statistical differences in neck pain reduction, only 1WS and 3WS reduced DASH. This study suggests some flexibility regarding time-wise distribution when implementing specific strength training at the workplace

Coping and Motivation for Change:An Interview Study of the Experience From Participation in an Educational Program for Patients With Medication-Overuse Headache

Patient educational programs (PEP) are recommended as part of the treatment for medication-overuse headache (MOH), however, knowledge of patients’ experiences when participating is sparse. This study explored how patients experienced participating in a PEP focusing on empowering coping strategies and motivation for behavioral changes. Eight individual semistructured interviews were conducted among patients suffering from MOH who had attended a PEP intervention in a randomized controlled trial. The PEP involved techniques from Motivational Interviewing as its communicative approach. Data collection, analysis, and interpretation were performed within a phenomenological-hermeneutic framework. Results showed that patients found the educational program relevant regarding coping with headache. Participants shifted from focusing on medication to include other ways to manage headache. Experiences regarding ambivalent feelings for behavioral change and feelings of stigmatization were key issues. Participation in this PEP helped the participants cope with headache in new ways relevant to their everyday lives and challenges. The individualized approach enabled by Motivational Interviewing was experienced as useful by the participants, as it actively involved them in the treatment.</p

Live music during haemodialysis:A multiple methods randomised controlled pilot study

BACKGROUND: Fatigue is an immense problem among patients undergoing haemodialysis and is associated with anxiety and depression. Live music used in different hospital settings has shown promising effects, but the feasibility and potential effectiveness of live music during haemodialysis are unknown.OBJECTIVES: To evaluate the feasibility, the participants' musical experience and potential effectiveness of live music on patients' levels of fatigue, relaxation, anxiety, depression, treatment satisfaction and work engagement among nurses.DESIGN: A pilot randomised controlled trial evaluated with a multiple methods design.PARTICIPANTS: Two clusters of 12 patients were each randomised to receive either 30 min of live music once a week during haemodialysis or usual care over a period of 6 weeks.MEASUREMENTS: The primary outcome was patients' immediate fatigue. Other outcomes were patients' long-term and post-dialysis fatigue, relaxation, anxiety, depression, treatment satisfaction and work engagement among nurses. Observations and semi-structured interviews with patients, nurses and musicians were conducted to gain an in-depth understanding of the musical experience as well as feasibility.RESULTS: The study was feasible and detected significant differences on immediate fatigue (p &lt; 0.001) and anxiety (p &lt; 0.012) in the intervention group compared to controls. Among 17 nurses, a significant difference was found in Dedication (p &lt; 0.024). Furthermore, live music gave patients an uplifting experience, bringing joy and relaxation and the nurses experienced a sense of quietness in a stressful day.CONCLUSIONS: Providing live music performed by professional musicians in a haemodialysis setting is feasible and showed a significant effect on immediate fatigue and anxiety compared to controls.</p

Readmission is experienced as inevitable among older adults receiving homecare:A qualitative interview study

Background: Older adults receiving homecare have an increased risk of readmission. The transition from hospital to home can be experienced as unsafe, and older adults describe themselves as vulnerable during the post-discharge period. Thus, the objective was to explore the experiences of unplanned readmissions among older adults who receive homecare. Methods: We conducted qualitative individual semi-structured interviews with older adults, 65 years or above, receiving homecare and being readmitted to an emergency department (ED) between August and October 2020. Data were analysed by systematic text condensation as described by Malterud. Findings: We included 12 adults aged 67–95 years, seven were male, and eight lived alone. The analysis derived three themes: (1) Responsibility and security at home, (2) the role of family, friends and homecare and (3) the importance of trust. The older adults felt that the hospital strived for too-early discharge, as they still did not feel well. They worried about how to manage their daily life. Active involvement of their family increased their sense of security, but those living alone described feeling anxious being at home by themselves after discharge. Although older adults did not wish to go to the hospital, inadequate treatment at home and the feeling of responsibility for their illness made them feel insecure. They expressed that earlier negative experiences affected their trust in the system and their inclination to ask for help. Conclusions: The older adults were discharged from the hospital despite feeling ill. They described inadequate competencies from healthcare professionals in the home as a contributing factor to their readmission. The readmission increased a sense of security. Support from the family in the process was essential and provided a sense of security, whereas older adults living alone experienced feelings of insecurity in the home environment.</p

The quality of life of older adults acutely admitted to the emergency department:A cross-sectional study

AIM: To investigate perceptions of individual QoL among acutely admitted older adults and explore whether homecare and readmission were associated with QoL.DESIGN: A cross-sectional study at three Danish Emergency Departments.METHODS: Semi-structured interviews, using the Schedule for the Evaluation of Individual Quality of Life - Direct Weighting (SEIQol-DW) (range 0-100) with patients ≥65 years, were conducted from August 2018 to July 2019. The differences between patients receiving homecare (yes/no) and readmission (yes/no) were tested using linear regression analyses with bootstrap procedures.RESULTS: Overall, we included 406 patients, of whom 38% received homecare. The mean SEIQoL-DW-score was 76 (SD = 19). The most important areas of individual QoL were Family, Social activities, Health, Everyday life and Leisure activities. Receiving homecare was associated to a significantly lower QoL score: -8 (SE = 2) and a significantly lower score in the categories Family and Health. There was no association between readmission and QoL.</p

Zoledronic Acid for prevention of bone and muscle loss after BAriatric Surgery (ZABAS)-a study protocol for a randomized controlled trial

Background: Bariatric surgery has adverse effects on the muscular-skeletal system with loss of bone mass and muscle mass and an increase in the risk of fracture. Zoledronic acid is widely used in osteoporosis and prevents bone loss and fracture. Bisphosphonates may also have positive effects on skeletal muscle. The aim of this study is to investigate the effects of zoledronic acid for the prevention of bone and muscle loss after bariatric surgery. Methods/design: This is a randomized double-blind placebo-controlled study. Sixty women and men with obesity aged 35 years or older will complete baseline assessments before randomization to either zoledronic acid (5 mg in 100 ml isotonic saline) or placebo (100 ml isotonic saline only) 3 weeks before surgery with Roux-en-Y-gastric bypass (RYGB) or sleeve gastrectomy (SG). Follow-up assessments are performed 12 and 24 months after surgery. The primary outcome is changes in lumbar spine volumetric bone mineral density (vBMD) assessed by quantitative computed tomography (QCT). Secondary bone outcomes are changes in proximal femur vBMD assessed by QCT. Changes in cortical and trabecular bone microarchitecture and estimated bone strength will be assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT). Cortical material bone strength at the mid-tibia diaphysis will be assessed using microindentation and fasting blood samples will be obtained to assess biochemical markers of bone turnover and calcium metabolism. Secondary muscle outcomes include whole body lean mass assessed using dual-energy X-ray absorptiometry. Dynamometers will be used to assess handgrip, shoulder, ankle, and knee muscle strength. Short Physical Performance Battery, 7.6-m walking tests, 2-min walking test, and a stair climb test will be assessed as biomarkers of physical function. Self-reported physical activity level is assessed using International Physical Activity Questionnaire (IPAQ). Discussion: Results from this study will be instrumental for the evidence-based care of patients undergoing bariatric surgery. Trial registration: ClinicalTrials.gov NCT04742010. Registered on 5 February 2021.</p

Statistical Analysis Plan:The effect of a combination of physical training, specific exercises and pain education compared with pain education alone in patients with chronic neck pain: a randomized control trial with a 4-month follow-up

This is the analysis plan for the multicentre randomised control study looking at the effect of training and exercises in chronic neck pain patients that is being conducted in Jutland and Funen, Denmark. This plan will be used as a work description for the analyses of the data collected

Contact activated kallikrein generation is reduced six months after gastric bypass

BackgroundProthrombotic and inflammatory variables decrease after obesity surgery. The contact activation system may be a common denominator of these changes.ObjectiveTo characterize the contact system before and 6 months after Roux-en-Y gastric bypass (RYGB) and to evaluate associations with changes (post-surgery minus pre-surgery) in metabolic variables.MethodsWomen (n = 42) and men (n = 18) with obesity underwent RYGB, and measures of kallikrein generation, factor XII (FXII), prekallikrein, high molecular weight kininogen (HK), and C1 esterase inhibitor (C1-inh) were determined before and 6 months after surgery. Associations were evaluated using correlation and multivariate regression analyses.ResultsAfter RYGB, the endogenous kallikrein potential (EKP), peak kallikrein generation, FXII, and prekallikrein were reduced, and kallikrein generation lag time was prolonged (all p &lt; 0.0005). Before and after RYGB, absolute values of EKP, lag time, and peak kallikrein generation correlated consistently with contact system proteins (range of correlation coefficients (rS): −0.43 to −0.28 and 0.24 to 0.45 (pre-surgery); −0.43 to −0.30 and 0.28 to 0.50 (post-surgery)). RYGB-associated changes in EKP correlated with C1-inh (rS = −0.29, p = 0.025), but also with triglycerides (rS = 0.34, p = 0.007) and cholesterol (rS = 0.28, p = 0.029), and independently associated with changes in C1-inh (β = −0.40) and triglycerides (β = 0.39). Changes in C1-inh associated with reductions in body weight (β = −0.39) and HbA1c (β = 0.38).ConclusionThe contact system was affected 6 months after RYGB. Absolute values of kallikrein generation before and after RYGB correlated with contact system proteins, whereas changes after RYGB associated with changes in C1-inh and metabolic variables