665 resultados para Cluster randomized trial
Resumo:
The lymphedema diagnostic method used in descriptive or intervention studies may influence results found. The purposes of this work were to compare baseline lymphedema prevalence in the physical activity and lymphedema (PAL) trial cohort and to subsequently compare the effect of the weight-lifting intervention on lymphedema, according to four standard diagnostic methods. The PAL trial was a randomized controlled intervention study, involving 295 women who had previously been treated for breast cancer, and evaluated the effect of 12 months of weight lifting on lymphedema status. Four diagnostic methods were used to evaluate lymphedema outcomes: (i) interlimb volume difference through water displacement, (ii) interlimb size difference through sum of arm circumferences, (iii) interlimb impedance ratio using bioimpedance spectroscopy, and (iv) a validated self-report survey. Of the 295 women who participated in the PAL trial, between 22 and 52% were considered to have lymphedema at baseline according to the four diagnostic criteria used. No between-group differences were noted in the proportion of women who had a change in interlimb volume, interlimb size, interlimb ratio, or survey score of ≥5, ≥5, ≥10%, and 1 unit, respectively (cumulative incidence ratio at study end for each measure ranged between 0.6 and 0.8, with confidence intervals spanning 1.0). The variation in proportions of women within the PAL trial considered to have lymphoedema at baseline highlights the potential impact of the diagnostic criteria on population surveillance regarding prevalence of this common morbidity of treatment. Importantly though, progressive weight lifting was shown to be safe for women following breast cancer, even for those at risk or with lymphedema, irrespective of the diagnostic criteria used.
Resumo:
Objective: To evaluate the feasibility and effect of a water-based exercise (WBE) program on lymphedema status and shoulder range of motion (ROM) among women with breast cancer related lymphedema. Design: Single-blinded, randomized controlled pilot trial. Twenty-nine eligible breast cancer survivors (median 10 years after surgery) with arm lymphedema (median 21% inter limb difference) were included and randomized into intervention (n= 15) or control (n=14). Twenty-five participants completed the study. The intervention was at least twice weekly WBE for 8 weeks; supervised initially but performed independently during the study period. Outcomes of interest were feasibility as measured by retention and adherence, lymphedema status as measured by optoelectronic perometry, bioimpedance spectroscopy and tissue dielectric constant, and shoulder range of motion (ROM) as measured by goniometer. Results: Four participants were not measured at post-intervention and were not included in the analysis (retention). Four participants in the intervention group did not perform the minimum WBE criteria set (adherence). No effect was found on lymphedema status. Compared to the control group, median ROM change for flexion was 6 (1-10) degrees (p<0.001) and 6 (0-15.5) degrees (p=0,07) for external rotation. Clinically relevant increase in the intervention group was found for 36% in flexion (p≤0.05) and (57%) in external rotation (p≤0.05) compared to controls. Conclusions: This study shows WBE is feasible for breast cancer survivors with arm lymphedema and that shoulder ROM can be improved years after cancer treatment has been completed.
Resumo:
We examined the effects of progressive resistance training (PRT) and supplementation with calcium-vitamin D(3) fortified milk on markers of systemic inflammation, and the relationship between inflammation and changes in muscle mass, size and strength. Healthy men aged 50-79 years (n = 180) participated in this 18-month randomized controlled trial that comprised a factorial 2 x 2 design. Participants were randomized to (1) PRT + fortified milk supplement, (2) PRT, (3) fortified milk supplement, or (4) a control group. Participants assigned to PRT trained 3 days per week, while those in the supplement groups consumed 400 ml day(-1) of milk containing 1,000 mg calcium plus 800 IU vitamin D(3). We collected venous blood samples at baseline, 12 and 18 months to measure the serum concentrations of IL-6, TNF-alpha and hs-CRP. There were no exercise x supplement interactions, but serum IL-6 was 29% lower (95% CI, -62, 0) in the PRT group compared with the control group after 12 months. Conversely, IL-6 was 31% higher (95% CI, -2, 65) in the supplement group compared with the non-supplemented groups after 12 and 18 months. These between-group differences did not persist after adjusting for changes in fat mass. In the PRT group, mid-tibia muscle cross-sectional area increased less in men with higher pre-training inflammation compared with those men with lower inflammation (net difference similar to 2.5%, p < 0.05). In conclusion, serum IL-6 concentration decreased following PRT, whereas it increased after supplementation with fortified milk concomitant with changes in fat mass. Furthermore, low-grade inflammation at baseline restricted muscle hypertrophy following PRT.
Resumo:
Purpose Exercise for Health was a randomized, controlled trial designed to evaluate two modes of delivering (face-to-face [FtF] and over-the-telephone [Tel]) an 8-month translational exercise intervention, commencing 6-weeks post-breast cancer surgery (PS). Methods Outcomes included quality of life (QoL), function (fitness and upper-body) and treatment-related side effects (fatigue, lymphoedema, body mass index, menopausal symptoms, anxiety, depression and pain). Generalised estimating equation modelling determined time (baseline [5-weeks PS], mid-intervention [6-months PS], post-intervention [12-months PS]), group (FtF, Tel, Usual Care [UC]) and time-by-group effects. 194 women representative of the breast cancer population were randomised to the FtF (n=67), Tel (n=67) and UC (n=60) groups. Results: There were significant (p<0.05) interaction effects on QoL, fitness and fatigue, with differences being observed between the treatment groups and the UC group. Trends observed for the treatment groups were similar. The treatment groups reported improved QoL, fitness and fatigue over time and changes observed between baseline and post-intervention were clinically relevant. In contrast, the UC group experienced no change, or worsening QoL, fitness and fatigue, mid-intervention. Although improvements in the UC group occurred by 12-months post-surgery, the change did not meet the clinically relevant threshold. There were no differences in other treatment-related side-effects between groups. Conclusion This translational intervention trial, delivered either face-to-face or over-the-telephone, supports exercise as a form of adjuvant breast cancer therapy that can prevent declines in fitness and function during treatment and optimise recovery post-treatment.
Resumo:
We conducted a randomized controlled trial to test whether a Brief Mobile Treatment (BMT) intervention could improve outcomes relative to usual care among suicide attempters. The intervention included training in problem solving therapy, meditation, a brief intervention to increase social support as well as advice on alcohol and other drugs, and mobile phone follow-up. The effect of the intervention was measured in terms of a reduction in suicidal ideation, depression and self-harm at Baseline, six and 12 months. A wait-list control group received usual care. A total of 68 participants was recruited from a Sri Lankan hospital following a suicide attempt. Participants who received the intervention were found to achieve significant improvements in reducing suicidal ideation and depression than those receiving usual care. The BMT group also experienced a significant improvement of social support when compared to the control group. However, the BMT group did not demonstrate a significant effect in reducing actual self-harm and most substance use, and differential effects on alcohol use were restricted to men. Although the present study was limited in revealing which component of the intervention was more effective in preventing suicide, it showed its efficacy in reducing suicide as a whole.
Resumo:
Purpose The aim was to assess the effects of a Tai Chi based program on health related quality of life (HR-QOL) in people with elevated blood glucose or diabetes who were not on medication for glucose control. Method 41 participants were randomly allocated to either a Tai Chi intervention group (N = 20) or a usual medical care control group (N = 21). The Tai Chi group involved 3 x 1.5 hour supervised and group-based training sessions per week for 12 weeks. Indicators of HR-QOL were assessed by self-report survey immediately prior to and after the intervention. Results There were significant improvements in favour of the Tai Chi group for the SF36 subscales of physical functioning (mean difference = 5.46, 95% CI = 1.35-9.57, P < 0.05), role physical (mean difference = 18.60, 95% CI = 2.16-35.05, P < 0.05), bodily pain (mean difference = 9.88, 95%CI = 2.06-17.69, P < 0.05) and vitality (mean difference = 9.96, 95% CI = 0.77-19.15, P < 0.05). Conclusions The findings show that this Tai Chi program improved indicators of HR-QOL including physical functioning, role physical, bodily pain and vitality in people with elevated blood glucose or diabetes who were not on diabetes medication.
Resumo:
This pilot study aimed to compare the effect of companion robots (PARO) to participation in an interactive reading group on emotions in people living with moderate to severe dementia in a residential care setting. A randomized crossover design, with PARO and reading control groups, was used. Eighteen residents with mid- to late-stage dementia from one aged care facility in Queensland, Australia, were recruited. Participants were assessed three times using the Quality of Life in Alzheimer’s Disease, Rating Anxiety in Dementia, Apathy Evaluation, Geriatric Depression, and Revised Algase Wandering Scales. PARO had a moderate to large positive influence on participants’ quality of life compared to the reading group. The PARO intervention group had higher pleasure scores when compared to the reading group. Findings suggest PARO may be useful as a treatment option for people with dementia; however, the need for a larger trial was identified.