Significant Between-group Mean Differences Research Articles

Effects of Limiting Recreational Screen Media Use on Physical Activity and Sleep in Families With Children

Children and adults spend large amounts of their leisure time using screen media, which may affect their health and behavior. To investigate the effect of reducing household recreational screen media use on physical activity and sleep in children and adults. This was a cluster randomized clinical trial with a 2-week follow-up. Enrollment began on June 6, 2019, and ended on March 30, 2021. This study included a population-based sample from 10 Danish municipalities. A total of 89 families (181 children and 164 adults) were recruited based on a population-based survey on screen media habits in families with children. To be eligible, the responding parent had to list self-reported recreational screen use greater than the 40th percentile of recreational screen time use in the source population (>2.4 hours per day). In addition, the parent had to be full-time employed (with no regular night shifts) or enrolled in full-time education. Families were randomly assigned to the screen media reduction intervention (45 families, 86 children, 82 adults) designed to ensure participant compliance to a maximum use of screen media (≤3 hours per week) for a 2-week period. Families randomly assigned to the control group (44 families, 95 children, 82 adults) were instructed to carry on as usual. The primary outcome was between-group difference in leisure nonsedentary activity (in minutes per day) measured by combined thigh and waist accelerometry. Secondary outcomes included other physical activity and sleep parameters measured by single-channel electroencephalography. Among the 89 randomized families (intervention group [45 families]: 86 children; mean [SD] age, 8.6 [2.7] years; 44 boys [51%]; 42 girls [49%]; control group [44 families]: 95 children, mean [SD] age, 9.5 [2.5] years; 38 boys [40%]; 57 girls [60%]), 157 children (87%) had complete data on the primary outcome. Eighty-three children (97%) in the intervention group were compliant to the screen use reduction during the intervention. The mean (SD) change in leisure nonsedentary activity in the intervention group was 44.8 (63.5) minutes per day and in the control group was 1.0 (55.1) minute per day (intention-to-treat between-group mean difference, 45.8 minutes per day; 95% CI, 27.9-63.6 minutes per day; P < .001). No significant between-group mean differences were observed between intervention and control for the electroencephalography-based sleep outcomes. In this cluster randomized clinical trial, a recreational screen media reduction intervention resulted in a substantial increase in children's engagement in physical activity. The large effect size suggests that the high levels of recreational screen media use seen in many children should be a public health concern. ClinicalTrials.gov Identifier: NCT04098913.

Percutaneous Electrolysis in the Treatment of Lateral Epicondylalgia: A Single-Blind Randomized Controlled Trial.

Few studies have considered the effects of percutaneous electrolysis (PE) in the treatment of lateral epicondylalgia (LE). For this reason, the objective of this study was to compare the effects of PE with an evidence-based approach—trigger point dry needling (TDN)—in patients with LE. A randomized controlled trial was conducted in which 32 participants with LE were randomly assigned to two treatment groups, the PE group (n = 16) and the TDN group (n = 16). Both groups received four therapy sessions and an eccentric exercise program to be performed daily. The numerical pain rating scale (NPRS), pressure pain thresholds (PPT), quality of life, and range of motion were measured before treatment, at the end of treatment, and at one- and three-month follow-ups. Significant between-group mean differences were found after treatment for NPRS (p < 0.001) and flexion movement (p = 0.006). At one-month follow-up, significant mean differences between groups were found for NPRS (p < 0.001), PPT (p = 0.021), and flexion (p = 0.036). At three-months follow-up, significant mean differences between groups were found for NPRS (p < 0.001), PPT (p = 0.004), and flexion (p = 0.003). This study provides evidence that PE could be more effective than TDN for short- and medium-term improvement of pain and PPTs in LE when added to an eccentric exercise program.

Quality of Life, Fatigue, and Sleep Problems in Pancreatic Cancer Patients—A Randomized Trial on the Effects of Exercise

Improving quality of life (QoL) is an important treatment goal in pancreatic cancer patients. Although the beneficial effects of exercise on QoL are well understood, few studies have investigated more aggressive cancers such as pancreatic cancer. Within a randomized trial, we assessed the efficacy of 6-month resistance training on physical functioning (primary outcome) and further QoL-related outcomes. 65 pancreatic cancer patients were assigned to home-based training, supervised training, or a usual care control group. Analysis-of-covariance models on changes from baseline to 6 and 3 months were ap- plied. 47 patients completed the intervention period. After 6 months, no effects of resistance training were observed. However, after 3 months, explorative analyses showed significant between-group mean differences (MD) in favor for resistance training for physical functioning (pooled group: MD=11.0; p=0.016; effect size[ES]=0.31), as well as for global QoL (MD=12.1; p=0.016; effect size=0.56), and other outcomes, such as sleep problems and fatigue. Multiple imputation analyses yielded similar results. Home-based and supervised training performed similarly. This first randomized resistance training trial in pancreatic cancer patients indicated clinically relevant improve- ments in QoL after 3 but not after 6 months. Given the severity of pancreatic cancer, exercise recommendations may already commence at surgery.

Psychometric Properties of the Family Inventory of Resources and Stressors in Families of Children with Emotional/Behavior Disorders: Ethnic/Racial and Developmental Differences

The Family Inventory of Resources and Stressors (FIRST) has been shown to have adequate psychometric properties in the assessment of families of children with emotional and behavior disorders (EBD). However, the extent to which ethnic/racial and developmental differences moderate the psychometric properties of this instrument is unknown. The study sample consisted of 150 families with an EBD child consecutively admitted to the Astor Transitions Program. This study seeks (1) to conduct a psychometric analysis of the FIRST subscales among African American and Hispanic/Latino families with older students versus early childhood students with EBD, and (2) to determine whether profiles will show greater stress for families of older students due to longer exposure to their EBD. Alpha coefficients were computed with a cutoff of 0.70 (or higher) indicating acceptable internal consistency reliability. Criterion variables reflecting family environment, mental health, and level of service correlated with relevant FIRST subscales assessed validity. Ethnic/racial and developmental effects were found to moderate the psychometric properties of the FIRST. No statistically significant between-group mean differences on the FIRST were found for families of early childhood versus older EBD students. Despite evidence of response bias on the part of families and lack of standardization during test administration by caseworkers, the current findings still reveal adequate reliability and limited validity of FIRST subscales.

Randomized, controlled trial of resistance training in breast cancer patients receiving adjuvant radiotherapy: results on cancer-related fatigue and quality of life

Exercise has been reported to decrease cancer-related fatigue and to increase quality of life (QoL) in various breast cancer (BC) populations. However, studies investigating exercise during radiotherapy or resistance training are scarce. We conducted a randomized, controlled trial (BEST study) to assess the efficacy of 12-week resistance training on fatigue beyond possible psychosocial effects of a group-based intervention. One hundred sixty patients with BC stage 0-III were randomly assigned to a 12-week progressive resistance training (2 times/week) or a 12-week relaxation control (RC, 2 times/week). Both interventions were group-based. The primary end point fatigue was assessed with a 20-item multidimensional questionnaire, QoL with EORTC questionnaires. Statistical analyses were based on analysis of covariance models for the individual changes from baseline to week 13. Adherence to the intervention program as well as the completion rate (97%) for the primary outcome variable fatigue was high. In intention-to-treat analyses for the N = 155 patients, significant between-group mean differences (MD) favoring the exercise group (EX) were observed for general fatigue (P = 0.044), especially for the subscale physical fatigue [MD = -0.8; 95% confidence interval -1.5 to -0.2, P = 0.013], but not for affective (P = 0.91) or cognitive fatigue (P = 0.65). For QoL, significantly larger improvements regarding the role function (P = 0.035) and pain (P = 0.040) were noted among exercisers compared with RCs. Future perspective improved significantly stronger in the RC group compared with the EX group (P = 0.047). The 12-week resistance training program was a safe, feasible and efficacious strategy to improve cancer-related fatigue and components of QoL in BC patients during adjuvant radiotherapy. As exercise was compared with another group-based intervention, results indicate that resistance training effects on fatigue and QoL go beyond psychosocial benefits, and that the clinically relevant overall benefit of resistance exercise compared with usual care can be assumed to be higher. ClinicalTrials.gov NCT01468766.

Effect of Exercise Training on Estimated GFR, Vascular Health, and Cardiorespiratory Fitness in Patients With CKD: A Pilot Randomized Controlled Trial

Exercise capacity, which is predictive of all-cause mortality and cardiovascular disease risk, is reduced significantly in patients with non-dialysis-dependent chronic kidney disease. This pilot study examined the effect of moderate-intensity exercise training on kidney function and indexes of cardiovascular risk in patients with progressive chronic kidney disease stages 3 to4. Single-blind, randomized, controlled, parallel trial. 20 patients (aged 18-80 years; 17 men) randomly assigned to rehabilitation (n=10) or usual care (n=10). Participants were included if they were 18 years or older and had evidence of rate of decline in creatinine-based estimated glomerular filtration rate (eGFRcr)≥2.9mL/min/1.73m(2) per year for 12 months preintervention. Patients were excluded if they had unstable medical conditions or had recently started regular exercise. The rehabilitation group received resistance and aerobic training (3 days per week) for a 12-month period. The usual care group received standard care. Kidney function assessed by comparing mean rate of change in eGFRcr (mL/min/1.73m(2) per year) from a 12-month preintervention period against the 12-month intervention period. Pulse wave velocity (PWV), peak oxygen uptake (Vo2peak), and waist circumference assessed at 0, 6, and 12 months. eGFR assessed using creatinine, cystatin C (eGFRcys), and a combination of both values (eGFRcr-cys). 18 participants (rehabilitation, 8; usual care, 10) completed the study. A significant mean difference in rate of change in eGFRcr (+7.8±3.0 [95% CI, 1.1-13.5] mL/min/1.73m(2) per year; P=0.02) was observed between the rehabilitation and usual care groups, with the rehabilitation group demonstrating a slower decline. No significant between-group mean differences existed in absolute eGFRcr, eGFRcr-cys, or eGFRcys at 12 months of study intervention. Significant between-group mean differences existed in PWV (-2.30 [95% CI,-3.02 to-1.59] m/s), waist circumference (-7.1±12.8 [95% CI,-12.4 to-3.2] cm), and Vo2peak (5.7 [95% CI, 1.34-10.10] mL/kg/min). Change in eGFRcr was correlated inversely with PWV (r=-0.5; P=0.04) at 12 months. Small sample size, inconsistency between primary and secondary measures of kidney function. The effect of a 1-year exercise intervention on progression of kidney disease is inconclusive. A larger study with longer follow-up may be necessary.

Mindfulness and positive affect: Cross-sectional, prospective intervention, and real-time relations

This study tested trait- and state-mindfulness and trait- and state-positive affect (PA) relations within a cross-sectional study (Study 1; N = 174, 76% women, Mean (SD)age = 24 (2.7) years) and a randomized controlled 4-session mindfulness intervention study (Study 2; N = 51, 65.4% women, Mean (SD)age = 25 (4.3) years). Study 1 : levels of trait-mindfulness and trait-like PA were related, as theorized, only among participants with meditation experience. Study 2 : Study 2 is a secondary analysis of a mindfulness intervention study [Tanay, Lotan, & Bernstein (2012). Salutary proximal processes and distal mood and anxiety vulnerability outcomes of mindfulness training: A Pilot preventive intervention. Behavior Therapy, 43, 492–505]. Unexpectedly, reduced levels of trait-like PA were observed pre- to post-intervention across conditions. No significant between-group mean differences were observed post-intervention. However, as expected, change in trait-mindfulness from pre- to post-intervention predicted change in trait-like PA among the intervention but not control condition. Second, levels of state-mindfulness during mindfulness meditation were positively related to levels of state-PA. The theoretical and applied implications of these findings for mindfulness and PA are discussed.

Training unsupported sitting in people with chronic spinal cord injuries: a randomized controlled trial

Randomized, assessor-blinded trial. To evaluate the effectiveness of a 6-week task-specific training programme on the abilities of people with chronic spinal cord injuries to sit unsupported. NSW, Australia. Thirty adults with spinal cord injuries of at least 1-year duration were recruited. Participants in the training group (n=15) performed up to 1 h of task-specific training three times a week for 6 weeks. Participants in the control group (n=15) did not receive any training or additional therapy. Primary outcome measures were the Canadian Occupational Performance Measure (COPM), and tests of Upper Body Sway, Maximal Balance Range and donning and doffing a T-shirt (the T-shirt test). The between-group mean difference (95% confidence interval) for the maximal balance range was 64 mm (95% confidence interval 20 to 108 mm; P=0.006). There were no significant between-group mean differences for the COPM and the Upper Body Sway and T-shirt tests. This trial shows initial support for intensive task-specific training for improving the abilities of people with chronic spinal cord injuries to sit unsupported, although the real-world implications of the observed treatment effects are yet to be determined.