Effects of mindfulness-based stress reduction on psychological distress in health workers: A three-arm parallel randomized controlled trial.
Journal of psychiatric research. 2022;:284-293
Mindfulness-based Stress Reduction (MBSR) has shown good efficacy for improving wellbeing in employees experiencing occupational stress. However, comparisons with other interventions, longer-term follow-up, and data from varying sociocultural contexts are lacking. This three-arm, parallel randomised controlled trial (RCT) examined the effects of MBSR on psychological distress in non-physician health workers in direct contact with patients. 105 participants were randomly allocated to either: (1) MBSR (N = 35), (2) Stress Management Course (SMC; N = 34) or (3) wait-list (N = 36). Participants and those assessing outcomes were blinded to group assignment. Participants completed questionnaires pre- and post-intervention and four months after the intervention. Psychological distress was measured using the General Health Questionnaire (GHQ-12) and Outcome Questionnaire (OQ-45). Secondary outcomes included perceived stress, job satisfaction, mindfulness skills and changes in salivary cortisol. 77 participants completed measures post-intervention and 52 at 4-month follow-up. MBSR showed a post-intervention effect in reducing GHQ-12 (ß = -0.80 [SE = 1.58] p < 0.01) and OQ-45 (ß = -0.72, [SE = 5.87] p < 0.05) psychological distress, compared to SMC and in reducing GHQ-12 (ß = -1.30 [SE = 1.38] p < 0.001) and OQ-45 (ß = -0.71, [SE = 5.58] p < 0.01) psychological distress compared to wait-list condition. In our secondary outcome, only MBSR was associated with a decrease in the cortisol awaking response by 23% (p < 0.05). At follow-up, only effects of MBSR on the psychological distress 'social role' subscale (ß = -0.76 [SE = 1.31] p < 0.05) remained significant, compared to SMC. In conclusion, MBSR appears useful in reducing short-term psychological distress in healthcare workers, but these effects were not maintained at follow-up. Trial registration: ISRCTN12039804.
Effects of trimetazidine in patients with severe chronic heart failure with reduced left ventricular ejection fraction: A prospective, randomized, open-label, cross-over study.
Cardiology journal. 2022;(4):627-636
BACKGROUND Trimetazidine (TMZ) modulates cardiac metabolism, but its use in heart failure remains controversial. The aim of the study was to evaluate the effects of TMZ on exercise capacity, left ventricular ejection fraction (LVEF), mortality, and quality of life in stable patients with heart failure with reduced left ventricular ejection fraction (HFrEF). METHODS Forty-five patients with stable advanced HFrEF treated with optimal medical therapy were randomized in a prospective, single-center, open-label, cross-over study of trimetazidine (35 mg b.i.d.) on top of standard medical therapy or standard pharmacotherapy for two periods of 30 days and one period of 6 months. Initially and at the end of each period all patients underwent the following: exercise testing, six-minute walk test (6MWT), two-dimensional-echocardiography, and quality of life assessment. RESULTS The mean age of patients was 58.2 ± 10.6 years. Etiology of HFrEF was ischemic in 66.6% of patients. After 6 months no significant changes were observed in either group with regards to peak VO₂ uptake, 6MWT, LVEF, or quality of life. TMZ had no effect on mortality or cardiovascular events. CONCLUSIONS The additional use of TMZ on top of standard medical therapy in stable advanced HFrEF patients was not associated with significant changes in mortality, exercise capacity, LVEF, or quality of life.
Two-year Outcomes of Prehabilitation Among Obese Patients With Ventral Hernias: A Randomized Controlled Trial (NCT02365194).
Annals of surgery. 2022;(2):288-294
OBJECTIVE To determine if preoperative nutritional counseling and exercise (prehabilitation) improve outcomes in obese patients seeking ventral hernia repair (VHR)? SUMMARY BACKGROUND DATA Obesity and poor fitness are associated with complications following VHR. It is unknown if preoperative prehabilitation improves outcomes of obese patients seeking VHR. METHODS This is the 2-year follow-up of a blinded randomized controlled trial from 2015 to 2017 at a safety-net academic institution. Obese patients (BMI 30-40) seeking VHR were randomized to prehabilitation versus standard counseling. Elective VHR was performed once preoperative requirements were met: 7% total body weight loss or 6 months of counseling and no weight gain. Primary outcome was percentage of hernia-free and complication-free patients at 2 years. Complications included recurrence, reoperation, and mesh complications. Primary outcome was compared using chi-square. We hypothesize that prehabilitation in obese patients with VHR results in more hernia- and complication-free patients at 2-years. RESULTS Of the 118 randomized patients, 108 (91.5%) completed a median (range) follow-up of 27.3 (6.2-37.4) months. Baseline BMI (mean±SD) was similar between groups (36.8 ± 2.6 vs 37.0 ± 2.6). More patients in the prehabilitation group underwent emergency surgery (5 vs 1) or dropped out of the program (3 vs 1) compared to standard counseling (13.6% vs 3.4%, P = 0.094). Among patients who underwent surgery, there was no difference in major complications (10.2% vs 9.1%, P = 0.438). At 2-years, there was no difference in percentage of hernia-free and complication-free patients (72.9% vs 66.1%, P = 0.424, 1.14, 0.88-1.47). CONCLUSION There is no difference in 2-year outcomes of obese patients seeking VHR who undergo prehabilitation versus standard care. Prehabilitation may not be warranted in obese patients undergoing elective VHR.Clinical Trial Registration: This trial was registered with clinicaltrials.gov (NCT02365194).
Immediate effect of voluntary-induced stepping response training on protective stepping in persons with chronic stroke: a randomized controlled trial.
Disability and rehabilitation. 2022;(3):420-427
PURPOSE To compare the immediate effects of voluntary-induced stepping response training (VSR) and DynSTABLE perturbation training (DST) on protective stepping in patients with stroke. METHODS A randomized controlled trial (registration number: TCTR20170827001) was conducted in 34 patients with chronic stroke who were randomly allocated to the VSR (n = 17) or DST (n = 17) group. The VSR group was instructed to lean forward to induce protective stepping, while the DST group experienced support surface translation. All participants received one session of training (3 set, 10 min for each set with 10-minute rest in between). Step length, step width, number of steps and center of mass (CoM) position during protective stepping were assessed using a computer-assisted rehabilitation environment (CAREN) system prior to and immediately after training. Two-way ANOVA was used to compare between groups and times. RESULTS Both types of training resulted in an increase in step width, but step length increased and there was a more positive COM position exhibited following DST (p < .05) than following VSR. Single-step incidence increased, whereas multiple-step incidence decreased significantly in both groups. Only participants in the VSR group generated protective stepping with the affected leg in a larger percentage of trials (27%) after training than before training. CONCLUSION Both DST and VSR led to changes in protective stepping parameters after a single session of training. VSR may be a feasible alternative to equipment-based training but requires further study.Implication for RehabilitationVSR and DST trainings improved protective stepping in stroke.Step length and CoM control at foot touchdown increased after DST training.VSR training for 50 minutes led to increase affected stepping and reduce grasping.Step width, affected step length, and single step increased after both trainings.Without instrument, VSR increased steps execution and performance similar to DST.
Feasibility and acceptability of a remotely delivered, home-based, pragmatic resistance 'exercise snacking' intervention in community-dwelling older adults: a pilot randomised controlled trial.
BMC geriatrics. 2022;(1):521
BACKGROUND Very few older adults meet current muscle strengthening exercise guidelines, and several barriers exist to supervised, community-based resistance exercise programs. Older adults therefore require access to feasible resistance exercise modalities that may be performed remotely. This pilot study assessed the feasibility and acceptability of undertaking a four-week home-based resistance 'exercise snacking' intervention (performed either once, twice, or thrice daily) when delivered and monitored remotely in older adults. METHODS Thirty-eight community-dwelling older adults [mean ± SD age 69.8 ± 3.8 y, 63% female] were randomised to complete resistance 'exercise snacks' (9-minute sessions) either once (n = 9), twice (n = 10), or thrice (n = 9) daily, or allocated to usual-activity control (n = 10). Exercise adherence and adverse events were assessed using an exercise diary, and acceptability of the intervention was explored using an online questionnaire. Physical function [balance, 5-times sit-to-stand (STS), and 30-second STS tests] was assessed remotely at baseline and follow-up using videoconferencing. RESULTS The intervention was feasible and safe, with 100% participant retention, high adherence (97, 82, and 81% for once, twice, and thrice daily, respectively), and only two adverse events from a total of 1317 'exercise snacking' sessions. The exercise intervention was rated as enjoyable (75% reported their enjoyment as ≥4 on a 5-point Likert scale), easy to perform, and most (82%) planned to continue similar exercise at home. We also found it was feasible to assess measures of physical function via videoconferencing, although effect sizes for 4-week changes in both 5-STS (d range, 0.4-1.4) and 30-STS (d range, 0.7-0.9) following the exercise intervention were similar to controls (d = 1.1 and 1.0 for 5-STS and 30-STS, respectively). CONCLUSIONS Resistance 'exercise snacking' may be a feasible strategy for engaging older adults in home-based resistance exercise when delivered and monitored remotely. The findings of this pilot feasibility trial support the need for longer-term studies in larger cohorts to determine the effectiveness of resistance 'exercise snacking' approaches for improving physical function in older adults. TRIAL REGISTRATION The trial was retrospectively registered on 10/11/2021 with the Australian New Zealand Clinical Trials Registry (ANZCTR) ( ACTRN12621001538831 ).
Effects of respiratory muscle training on respiratory efficiency and health-related quality of life in sedentary women with fibromyalgia: a randomised controlled trial.
Clinical and experimental rheumatology. 2022;(6):1119-1126
OBJECTIVES Fibromyalgia syndrome (FM) is a complex disease that is mainly characterised by chronic pain, fatigue, and sleep disturbances and may be precipitated or worsened by many stressors. The aim of this study was to examine the effects of respiratory muscle training (RMT) on respiratory efficiency and health-related quality of life (HRQoL) in women with FM. METHODS A total of 30 women with FM were included in the intention to treat analyses: 15 were assigned to the RMT group and 15 to the control group. The intervention consisted of 12 weeks of RMT. The primary outcome was the change in pulmonary function assessed by global body plethysmography at 12 weeks compared with baseline. Secondary outcomes included changes of scores in HRQoL assessed by the Short Form 36 Health Survey-Portuguese version. RESULTS The maximal inspiratory pressure (MIP) improved by 17.5% (p-value = .033), maximal expiratory pressure (MEP) improved 21.6% (p-value = 0.045) and maximum occlusion pressure (P0.1 max) increased 27.7% (p-value = 0.007). HRQoL improved in the dimensions of physical function, physical role, bodily pain and vitality (p-value <0.05). CONCLUSIONS RMT results in a significant improvement of respiratory efficiency and HRQoL after 12 weeks. RMT could be an effective therapy to enhance respiratory function and quality of life in women with FM.
Long Term Physical Activity Improves Quality of Life Perception, Healthy Nutrition, and Daily Life Management in Elderly: A Randomized Controlled Trial.
Physical activity (PA) is a key element in the management of successful aging. The aim of this paper was to show the effects of PA on the quality of life perception, nutritional status, and daily life management of 178 older adults (aged 63.87 ± 8.17) randomly assigned to an Experimental Group (EG), which performed moderate-to-high intensity aerobic and strengthening training, and a Control Group (CG) which performed low-impact PA, assessed after 6, 12, and 24 months. The Short-Form Health Survey (SF-36), Mini Nutritional Assessment (MNA), and Physical Activity Scale for the Elderly (PASE) were used for the study. In the SF-36 assessment, EG showed a good quality of life perception maintained after 24 months, while CG showed a worsening in the same period (p = 0.018). The EG reported a significant better nutritional status as compared to pre-intervention assessment (p = 0.003) and to CG (p < 0.001). Regarding the PASE, the EG showed a higher level of weekly activities than the CG after 24 months (p = 0.011), while the CG showed a worsening after 12 months (p = 0.008). The prolonged engagement in moderate-to high-intensity PA allowed the maintenance of a good quality of life perception, a good level of nutritional status, and daily life activities.
Smoking and other health factors in patients with head and neck cancer.
Cancer epidemiology. 2022;:102202
BACKGROUND Information on smoking and other health factors in head and neck cancer (HNC) patients throughout treatment, follow-up and survivorship is limited. This study explores patterns of multiple health factors during radiotherapy (RT) and naturalistic long-term follow-up in a convenience sample of patients with HNC. METHODS Smoking, alcohol use and depression were measured at baseline, 4 and 12 weeks post RT for a sub-group of 99 patients who participated in a randomised controlled trial and completed long-term follow-up. These factors plus healthy eating, physical activity and fatigue are also reported from the long-term follow-up component. Smoking was measured by self-report and biochemically, whilst all other variables were by self-report. Where variables were assessed at multiple time points logistic mixed effects regression models determined within-person changes over time. RESULTS There were important discrepancies between self-reported (4-7%) and biochemically verified (13-29%) rates of smoking. Rates of smoking and hazardous alcohol intake were significantly increased at follow-up compared to baseline. Depression rates were observed to be higher at end of RT compared to baseline. At long-term follow-up, fatigue was common and co-occurred with suboptimal healthy eating and hazardous alcohol use. CONCLUSION Clinically important levels of smoking and alcohol consumption post RT in this sample suggest possible targets for intervention beyond treatment into long-term follow-up of patients.
Effects of a multicomponent resistance-based exercise program with protein, vitamin D and calcium supplementation on cognition in men with prostate cancer treated with ADT: secondary analysis of a 12-month randomised controlled trial.
BMJ open. 2022;(6):e060189
OBJECTIVES The aim of this preplanned secondary analysis of a 12-month randomised controlled trial was to investigate the effects of a multicomponent exercise programme combined with daily whey protein, calcium and vitamin D supplementation on cognition in men with prostate cancer treated with androgen deprivation therapy (ADT). DESIGN 12-month, two-arm, randomised controlled trial. SETTING University clinical exercise centre. PARTICIPANTS 70 ADT-treated men were randomised to exercise-training plus supplementation (Ex+ Suppl, n=34) or usual care (control, n=36). INTERVENTION Men allocated to Ex + Suppl undertook thrice weekly resistance training with weight-bearing exercise training plus daily whey protein (25 g), calcium (1200 mg) and vitamin D (2000 IU) supplementation. PRIMARY AND SECONDARY OUTCOME MEASURES Cognition was assessed at baseline, 6 and 12 months via a computerised battery (CogState), Trail-making test, Rey auditory-verbal learning test and Digit span. Data were analysed with linear mixed models and an intention-to-treat and prespecified per-protocol approach (exercise-training: ≥66%, nutritional supplement: ≥80%). RESULTS Sixty (86%) men completed the trial (Ex + Suppl, n=31; control, n=29). Five (7.1%) men were classified as having mild cognitive impairment at baseline. Median (IQR) adherence to the exercise and supplement was 56% (37%-82%) and 91% (66%-97%), respectively. Ex + Suppl had no effect on cognition at any time. CONCLUSIONS A 12-month multicomponent exercise training and supplementation intervention had no significant effect on cognition in men treated with ADT for prostate cancer compared with usual care. Exercise training adherence below recommended guidelines does not support cognitive health in men treated with ADT for prostate cancer. TRIAL REGISTRATION NUMBER Australian and New Zealand Clinical Trial Registry (ACTRN12614000317695, registered 25/03/2014) and acknowledged under the Therapeutic Goods Administration Clinical Trial Notification Scheme (CT-2015-CTN-03372-1 v1).
Trunk stabilising exercises promote sternal stability in patients after median sternotomy for heart valve surgery: a randomised trial.
Journal of physiotherapy. 2022;(3):197-202
QUESTION What is the effect of trunk stabilising exercises on sternal stability in women who have undergone heart valve surgery via median sternotomy? DESIGN Randomised controlled trial with concealed allocation, assessor blinding and intention-to-treat analysis. PARTICIPANTS Thirty-six women aged 40 to 50 years who had undergone heart valve surgery via median sternotomy 7 days before enrolment. INTERVENTION All participants in both groups received cardiac rehabilitation during hospitalisation and three times per week for 4 weeks after discharge. In addition, participants in the experimental group were prescribed a regimen of trunk stabilising exercises to be performed three times per week for 4 weeks. At each exercise session, each of 11 exercises were to be performed with five to ten repetitions. OUTCOME MEASURES The primary outcome was sternal separation (the distance between the two halves of the bisected sternum). The secondary outcome was the Sternal Instability Scale from 0 (no instability) to 3 (an unstable sternum with substantial movement or separation). Measures were taken before and after the 4-week intervention period. RESULTS After the 4-week intervention period, the experimental group had a greater decrease in sternal separation by 0.09 cm (95% CI 0.07 to 0.11). The experimental group was twice as likely to improve by at least one grade on the Sternal Instability Scale by 4 weeks (RR 2.00, 95% CI 1.07 to 3.75). The experimental group was almost three times as likely to have a clinically stable sternum (grade 0 on the Sternal Instability Scale) by 4 weeks (RR 2.75, 95% CI 1.07 to 7.04). CONCLUSION Trunk stabilising exercises were an effective and feasible method of promoting sternal stability in women who underwent heart valve surgery via median sternotomy. TRIAL REGISTRATION NCT04632914.