Search

• We will monitor compliance with the intervention and adverse events. • Data will be analyzed following intention-to-treat principles. • A cost-effectiveness analysis will be performed. This a priori statistical analysis plan describes the methods of analysis for the Trial Of Prevention Strategies for low back pain (TOPS). TOPS aimed to investigate the effectiveness and cost-effectiveness of exercise and education classes compared with a minimal intervention control in preventing recurrence of low back pain (LBP) in people who have recently recovered from an episode of LBP. TOPS is a superiority, pragmatic, parallel-group randomized controlled trial with allocation concealment, blinded outcome assessors, and intention-to-treat analysis. Participants were randomized to a physical therapist-led exercise and education program for 12 weeks or minimal intervention. The primary outcome was days to recurrence of an episode of LBP. The three key secondary outcomes were days to recurrence of an episode of LBP resulting in (1) activity limitation, (2) care seeking for LBP; and (3) work absence of at least 1 day. Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression. Hazard ratios (HRs) and median survival times with 95% confidence intervals (CI) will be calculated. The number of adverse events, including serious adverse events will be reported and the proportion of adverse events between groups will be compared using a Chi-squared test. This paper will provide a detailed description of the planned analyses for the TOPS trial. Australian New Zealand Clinical Trials Registry (ACTRN12615000939594). [ABSTRACT FROM AUTHOR]

• There is a lack of information about the effectiveness of foot-ankle muscle strengthening program on pain and functioning in people with KOA. • An 8-week foot-ankle muscle strengthening program decreased knee pain and enhanced physical function in individuals with KOA, presenting a potential to be clinically meaningful. • Foot-ankle muscle strengthening program can be a treatment option for individuals with knee osteoarthritis (KOA) who do not tolerate exercises with excessive load on the knee. Foot-ankle exercises could improve pain and function of individuals with KOA and need to be tested. To investigate whether an 8-week foot-ankle muscle strengthening program is effective for individuals with KOA to reduce pain and improve function. In this randomized controlled trial, individuals diagnosed with clinical and radiographic KOA were randomized into the intervention (supervised foot-ankle strengthening exercise program three times a week for 8 weeks) or control (usual care and recommendations of the healthcare team) group. Effectiveness was assessed by changes in clinical and functional outcomes between baseline and 8 weeks with pain as the primary outcome. ANCOVA tests using the intervention group as a reference and sex, body mass index, and baseline values as covariates assessed between-group differences. The intervention group showed lower pain scores (−4.4 units; 95%CI = −7.5, −1.1), better function (−7.1 units; 95%CI = −12.7, −1.4), higher total functional score (−11.9 units; 95%CI = −20.7, −3.1), with confidence intervals indicating a potential for the differences to be clinically meaningful, and better scores for the 30-s chair stand test (2.7 repetitions; 95%CI = 1.1, 4.1), with a confidence interval indicating a moderate clinically meaningful difference, compared to the controls. The 8-week foot-ankle exercise program showed positive, and potentially clinically meaningful, effects on knee pain and physical function among individuals with KOA, when compared to usual care. NCT04154059. https://clinicaltrials.gov/ct2/show/NCT04154059 [ABSTRACT FROM AUTHOR]

Physical activity in people with dementia (PwD) may enhance physical and mental functioning. Exergaming, which combines physical exercise with cognitive stimulation in a gaming environment, was developed to overcome barriers in performing physical activities. We evaluated the effects of exergaming in day care centers (DCCs) for PwD and informal caregivers (ICs). A randomized controlled trial among 23 DCCs across the Netherlands randomized to exergaming (interactive cycling during 6 months) or a care-as-usual control group. A total of 112 (73 exergaming, 39 control) community-dwelling dyads (PwD, IC), with the PwD visiting a DCC at least twice per week. All outcomes were assessed using structured questionnaires during interviews with PwD and ICs at baseline (T0), 3 months (T1), and 6 months (T2). Primary outcomes: physical activity and mobility of the PwD. Secondary outcomes: physical, cognitive, emotional and social functioning, and quality of life for PwD. For ICs: experienced burden, quality of life, and positive care experiences. Mixed-model analyses showed no statistically significant effects on primary outcomes. There were statistically significant positive effects on PwD's secondary outcomes at T2 on cognition [Mini-Mental State Examination (MMSE): r = 2.30, 95% confidence interval (CI): 0.65, 3.96, P =.007; and Trail Making Test part A (TMT-A): r = −28.98, 95% CI: −54.89, −3.08, P =.029], social functioning (Behavior Observation Scale for Intramural Psychogeriatrics subscale 1 (GIP): r = −1.86, 95% CI: −3.56, −0.17, P =.031), and positive post-test effects in ICs on distress caused by the PwD's neuropsychiatric symptoms (NPI-Q total distress: r = −3.30, 95% CI: −6.57, −0.03, P =.048) and on sense of competence (SSCQ: r = 2.78, 95% CI: 0.85, 4.71, P =.005). Exergaming appeared not effective on the primary outcomes. Despite the study being underpowered, we found positive effects on secondary outcomes for PwD and ICs, and no negative effects. We therefore recommend further study, dissemination, and implementation. [ABSTRACT FROM AUTHOR]