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Trials Jul 2024Moderately severe or major trauma (injury severity score (ISS) > 8) is common, often resulting in physical and psychological problems and leading to difficulties in...
Early vocational rehabilitation and psychological support for trauma patients to improve return to work (the ROWTATE trial): study protocol for an individually randomised controlled multicentre pragmatic trial.
BACKGROUND
Moderately severe or major trauma (injury severity score (ISS) > 8) is common, often resulting in physical and psychological problems and leading to difficulties in returning to work. Vocational rehabilitation (VR) can improve return to work/education in some injuries (e.g. traumatic brain and spinal cord injury), but evidence is lacking for other moderately severe or major trauma.
METHODS
ROWTATE is an individually randomised controlled multicentre pragmatic trial of early VR and psychological support in trauma patients. It includes an internal pilot, economic evaluation, a process evaluation and an implementation study. Participants will be screened for eligibility and recruited within 12 weeks of admission to eight major trauma centres in England. A total of 722 participants with ISS > 8 will be randomised 1:1 to VR and psychological support (where needed, following psychological screening) plus usual care or to usual care alone. The ROWTATE VR intervention will be provided within 2 weeks of study recruitment by occupational therapists and where needed, by clinical psychologists. It will be individually tailored and provided for ≤ 12 months, dependent on participant need. Baseline assessment will collect data on demographics, injury details, work/education status, cognitive impairment, anxiety, depression, post-traumatic distress, disability, recovery expectations, financial stress and health-related quality of life. Participants will be followed up by postal/telephone/online questionnaires at 3, 6 and 12 months post-randomisation. The primary objective is to establish whether the ROWTATE VR intervention plus usual care is more effective than usual care alone for improving participants' self-reported return to work/education for at least 80% of pre-injury hours at 12 months post-randomisation. Secondary outcomes include other work outcomes (e.g. hours of work/education, time to return to work/education, sickness absence), depression, anxiety, post-traumatic distress, work self-efficacy, financial stress, purpose in life, health-related quality of life and healthcare/personal resource use. The process evaluation and implementation study will be described elsewhere.
DISCUSSION
This trial will provide robust evidence regarding a VR intervention for a major trauma population. Evidence of a clinically and cost-effective VR intervention will be important for commissioners and providers to enable adoption of VR services for this large and important group of patients within the NHS.
TRIAL REGISTRATION
ISRCTN: 43115471. Registered 27/07/2021.
Topics: Humans; Return to Work; Rehabilitation, Vocational; Time Factors; England; Treatment Outcome; Wounds and Injuries; Pragmatic Clinical Trials as Topic; Cost-Benefit Analysis; Multicenter Studies as Topic; Quality of Life; Health Care Costs
PubMed: 38956682
DOI: 10.1186/s13063-024-08183-w -
Trials Jul 2024Low anterior resection syndrome (LARS) is a distressing condition that affects approximately 25-80% of patients following surgery for rectal cancer. LARS is...
Biofeedback combined with percutaneous electrical pudendal nerve stimulation for the treatment of low anterior rectal resection syndrome: a study protocol for a randomized controlled trial.
BACKGROUND
Low anterior resection syndrome (LARS) is a distressing condition that affects approximately 25-80% of patients following surgery for rectal cancer. LARS is characterized by debilitating bowel dysfunction symptoms, including fecal incontinence, urgent bowel movements, and increased frequency of bowel movements. Although biofeedback therapy has demonstrated effectiveness in improving postoperative rectal control, the research results have not fulfilled expectations. Recent research has highlighted that stimulating the pudendal perineal nerves has a superior impact on enhancing pelvic floor muscle function than biofeedback alone. Hence, this study aims to evaluate the efficacy of a combined approach integrating biofeedback with percutaneous electrical pudendal nerve stimulation (B-PEPNS) in patients with LARS through a randomized controlled trial (RCT).
METHODS AND ANALYSIS
In this two-armed multicenter RCT, 242 participants with LARS after rectal surgery will be randomly assigned to undergo B-PEPNS (intervention group) or biofeedback (control group). Over 4 weeks, each participant will undergo 20 treatment sessions. The primary outcome will be the LARS score. The secondary outcomes will be anorectal manometry and pelvic floor muscle electromyography findings and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29) scores. Data will be collected at baseline, post-intervention (1 month), and follow-up (6 months).
DISCUSSION
We anticipate that this study will contribute further evidence regarding the efficacy of B-PEPNS in alleviating LARS symptoms and enhancing the quality of life for patients following rectal cancer surgery.
TRIAL REGISTRATION
Chinese Clincal Trials Register ChiCTR2300078101. Registered 28 November 2023.
Topics: Humans; Biofeedback, Psychology; Pudendal Nerve; Randomized Controlled Trials as Topic; Treatment Outcome; Transcutaneous Electric Nerve Stimulation; Quality of Life; Fecal Incontinence; Rectal Neoplasms; Female; Multicenter Studies as Topic; Middle Aged; Syndrome; Male; Adult; Pelvic Floor; Recovery of Function; China; Defecation; Aged; Proctectomy; Postoperative Complications; Electromyography; Manometry
PubMed: 38956630
DOI: 10.1186/s13063-024-08300-9 -
Systematic Reviews Jul 2024The acute and long-term benefits of exercise training on cardiovascular health have been well established. The systematic review and meta-analysis aimed to... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The acute and long-term benefits of exercise training on cardiovascular health have been well established. The systematic review and meta-analysis aimed to systematically assess the effectiveness of exercise training on arterial stiffness and blood pressure among postmenopausal women with elevated blood pressure.
METHODS
A comprehensive search was conducted on PubMed, Embase, Web of Science, ProQuest, Cochrane Library, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov website from inception to September 30, 2023, to identify the randomized controlled trials (RCTs), which evaluated the effectiveness of exercise training on arterial stiffness and blood pressure in postmenopausal women. Standardized mean differences (SMD), weighted mean differences (WMD), and 95% confidence intervals (95% CIs) were calculated using random/fixed effects models. Quality assessment was performed using the modified Jadad scale and the Cochrane Risk of Bias Tool. Sensitivity analysis and subgroup analysis were conducted based on drug dosage, treatment duration, and age of administration to further explore potential heterogeneity. Funnel plots were performed to assess publication bias and Begg's regression test was carried out for funnel plot asymmetry.
RESULTS
Twenty-two RCTs involving 1978 participants were included in the quantitative analysis. The mean quality of eligible studies was 4.2 out of 7 based on the modified Jadad scale. The results indicated that exercise training had a significant effect on reducing brachial-ankle pulse wave velocity [MD = - 0.69, 95%CI (- 1.11, - 0.27), P = 0.001], decreasing augmentation index (AIx) [MD = - 6.00, 95%CI (- 6.39, - 5.61), P < 0.00001] and AIx normalized to a heart rate of 75 beats per minute (AIx@75%) [MD = - 7.01, 95%CI - 7.91 to - 6.12, P < 0.00001], lowering systolic blood pressure [MD = - 6.19, 95%CI - 9.24 to - 3.15, P < 0.0001], diastolic blood pressure [MD = - 3.57, 95%CI (- 6.10, - 1.03), P = 0.006) and pulse pressure [MD = - 8.52, 95%CI (- 16.27, - 0.76), P = 0.03]. Subgroup analysis revealed that baseline blood pressure levels had a large impact on the effect of exercise training.
CONCLUSIONS
The systematic review and meta-analysis suggested that exercise training may ameliorate arterial stiffness and reduce blood pressure in postmenopausal women with elevated blood pressure. However, the optimal mode of exercise training that improves arterial stiffness and blood pressure in this population requires further investigation.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42021211268.
Topics: Humans; Vascular Stiffness; Postmenopause; Female; Blood Pressure; Exercise; Pulse Wave Analysis; Hypertension; Randomized Controlled Trials as Topic; Exercise Therapy
PubMed: 38956626
DOI: 10.1186/s13643-024-02589-y -
BMC Health Services Research Jul 2024The COVID-19 pandemic has greatly affected the lives, health, and social well-being of people globally including presenting special challenges in low to middle income...
The COVID-19 pandemic has greatly affected the lives, health, and social well-being of people globally including presenting special challenges in low to middle income countries for people living with HIV. This study investigates the pandemic experiences of the four key HIV-positive populations in Indonesia: men who have sex with men, transgender women, female sex workers, and people who use drugs. In-depth interviews were conducted with a convenience sample of 22 key population members recruited through 9 nongovernment HIV agencies in Jakarta and Bali, Indonesia. Indonesia's Large-scale Social Restrictions Policy mandating physical distancing and stay-at-home orders had been in effect for 7-10 months at the time of the interviews. The interviews were audio-recorded, transcribed, and coded using NVivo™ (R1.7) software. A grounded theory approach identified key concepts along with similarities, differences, and reoccurring patterns of COVID-19 lived experience among participants. Participants recounted the impact of both the pandemic and the Restriction Policy on their interpersonal, financial, medical, and psychosocial well-being. When in need, they turned to formal and informal sources of financial and social support plus their own resourcefulness. Along with other factors, HIV medication shortages, HIV and COVID-19 related stigma, and fear of acquiring COVID-19 negatively impacted their antiretroviral adherence and the use of health services. The results point to the latent consequences of government attempts to curb a pandemic through public health lockdowns and enforced policies of physical separation. Its findings reveal the importance of ensuring that public safety nets for HIV key populations are available to supplement more informal personal sources of needed support.
Topics: Humans; Indonesia; Male; COVID-19; HIV Infections; Female; Adult; Social Support; SARS-CoV-2; Middle Aged; Qualitative Research; Pandemics; Interviews as Topic; Sex Workers; Social Stigma; Transgender Persons; Patient Acceptance of Health Care
PubMed: 38956516
DOI: 10.1186/s12913-024-11227-1 -
BMC Cancer Jul 2024Developing cancer in young adulthood is a non-normative life event and associated with adverse physical, social and psychological consequences. High psychological... (Randomized Controlled Trial)
Randomized Controlled Trial
Peer2Me - evaluation of a peer supported program for adolescent and young adult (AYA) cancer patients: study protocol of a randomised trial using a comprehensive cohort design.
BACKGROUND
Developing cancer in young adulthood is a non-normative life event and associated with adverse physical, social and psychological consequences. High psychological distress is common in AYA cancer patients including anxiety, depression or fear of recurrence. At the same time, it is well known that AYA often report unmet needs for support, particularly in terms of informational exchange and emotional support from peers in order to benefit from shared experiences and enhance self-efficacy. Especially in the AYA group, interactions with other same-aged cancer patients may represent an essential resource in terms of coping with the disease, as family members and friends are often overwhelmed and struggling with helplessness. Currently, there is a lack of professional support services using peer support (e.g. psycho-oncological support, aftercare consultations, social legal counselling) or evaluated peer support interventions in Germany. Our aim is to assess the effectiveness of the Peer2Me intervention for AYAs, in which acute patients (mentees) are accompanied by an AYA survivor (mentor) over a period of three months.
METHODS
A prospective Comprehensive Cohort Design with repeated measures will be used to evaluate the effectiveness of Peer2Me for AYA. A sample of 180 patients in active cancer treatment aged 18 to 39 years will be enrolled and randomized to the intervention or control condition (a single AYA-specific consultation). Following mentor training, mentees and mentors are matched by diagnosis, age, and gender. The primary outcome is self-efficacy; secondary outcomes include measures of anxiety, depression, health literacy, life satisfaction and social support life. Outcomes will be measured at baseline before the intervention (t1), immediately after completion of the three-month intervention (t2) and three months after completion the intervention (t3). For the final analyses, we will use an intention-to-treat approach (ITT) and compare patients in the assigned treatment groups.
DISCUSSION
Peer2Me might be an important addition to existing professional psychosocial support services for young cancer patients. At the end of the study, a psycho-oncological intervention for young cancer patients undergoing acute treatment should be available, from which both mentors and mentees could benefit. The long-term continuity of Peer2Me should be ensured through collaboration with different partners.
TRIAL REGISTRATION
The study was retrospectively registered on February 4, 2022 at clinicaltrials.gov (NCT05336318).
Topics: Humans; Peer Group; Adolescent; Young Adult; Neoplasms; Adult; Female; Social Support; Male; Prospective Studies; Adaptation, Psychological; Cancer Survivors; Quality of Life; Germany; Randomized Controlled Trials as Topic
PubMed: 38956510
DOI: 10.1186/s12885-024-12547-5 -
Cell Death & Disease Jul 2024
Correction: Pivotal role of IL-8 derived from the interaction between osteosarcoma and tumor-associated macrophages in osteosarcoma growth and metastasis via the FAK pathway.
PubMed: 38956396
DOI: 10.1038/s41419-024-06795-3 -
Scientific Reports Jul 2024Plyometric training is characterized by high-intensity exercise which is performed in short term efforts divided into sets. The purpose of the present study was twofold:... (Randomized Controlled Trial)
Randomized Controlled Trial
Plyometric training is characterized by high-intensity exercise which is performed in short term efforts divided into sets. The purpose of the present study was twofold: first, to investigate the effects of three distinct plyometric exercise protocols, each with varying work-to-rest ratios, on muscle fatigue and recovery using an incline-plane training machine; and second, to assess the relationship between changes in lower limb muscle strength and power and the biochemical response to the three exercise variants employed. Forty-five adult males were randomly divided into 3 groups (n = 15) performing an exercise of 60 rebounds on an incline-plane training machine. The G0 group performed continuous exercise, while the G45 and G90 groups completed 4 sets of 15 repetitions, each set lasting 45 s with 45 s rest in G45 (work-to-rest ratio of 1:1) and 90 s rest in G90 (1:2 ratio). Changes in muscle torques of knee extensors and flexors, as well as blood lactate (LA) and ammonia levels, were assessed before and every 5 min for 30 min after completing the workout. The results showed significantly higher (p < 0.001) average power across all jumps generated during intermittent compared to continuous exercise. The greatest decrease in knee extensor strength immediately post-exercise was recorded in group G0 and the least in G90. The post-exercise time course of LA changes followed a similar pattern in all groups, while the longer the interval between sets, the faster LA returned to baseline. Intermittent exercise had a more favourable effect on muscle energy metabolism and recovery than continuous exercise, and the work-to-rest ratio of 1:2 in plyometric exercises was sufficient rest time to allow the continuation of exercise in subsequent sets at similar intensity.
Topics: Humans; Male; Rest; Muscle Fatigue; Adult; Muscle Strength; Plyometric Exercise; Young Adult; Muscle, Skeletal; Lactic Acid; Ammonia; Exercise
PubMed: 38956280
DOI: 10.1038/s41598-024-66146-2 -
Nature Medicine Jul 2024Preclinical evidence demonstrates that senescent cells accumulate with aging and that senolytics delay multiple age-related morbidities, including bone loss. Thus, we...
Preclinical evidence demonstrates that senescent cells accumulate with aging and that senolytics delay multiple age-related morbidities, including bone loss. Thus, we conducted a phase 2 randomized controlled trial of intermittent administration of the senolytic combination dasatinib plus quercetin (D + Q) in postmenopausal women (n = 60 participants). The primary endpoint, percentage changes at 20 weeks in the bone resorption marker C-terminal telopeptide of type 1 collagen (CTx), did not differ between groups (median (interquartile range), D + Q -4.1% (-13.2, 2.6), control -7.7% (-20.1, 14.3); P = 0.611). The secondary endpoint, percentage changes in the bone formation marker procollagen type 1 N-terminal propeptide (P1NP), increased significantly (relative to control) in the D + Q group at both 2 weeks (+16%, P = 0.020) and 4 weeks (+16%, P = 0.024), but was not different from control at 20 weeks (-9%, P = 0.149). No serious adverse events were observed. In exploratory analyses, the skeletal response to D + Q was driven principally by women with a high senescent cell burden (highest tertile for T cell p16 (also known as CDKN2A) mRNA levels) in which D + Q concomitantly increased P1NP (+34%, P = 0.035) and reduced CTx (-11%, P = 0.049) at 2 weeks, and increased radius bone mineral density (+2.7%, P = 0.004) at 20 weeks. Thus, intermittent D + Q treatment did not reduce bone resorption in the overall group of postmenopausal women. However, our exploratory analyses indicate that further studies are needed testing the hypothesis that the underlying senescent cell burden may dictate the clinical response to senolytics. ClinicalTrials.gov identifier: NCT04313634 .
PubMed: 38956196
DOI: 10.1038/s41591-024-03096-2 -
Scientific Reports Jul 2024The INSPIRE randomized clinical trial demonstrated that a high protein diet (HPRO) combined with neuromuscular electrical stimulation (NMES) attenuates muscle atrophy... (Randomized Controlled Trial)
Randomized Controlled Trial
Identification of metabolites associated with preserved muscle volume after aneurysmal subarachnoid hemorrhage due to high protein supplementation and neuromuscular electrical stimulation.
The INSPIRE randomized clinical trial demonstrated that a high protein diet (HPRO) combined with neuromuscular electrical stimulation (NMES) attenuates muscle atrophy and may improve outcomes after aneurysmal subarachnoid hemorrhage We sought to identify specific metabolites mediating these effects. Blood samples were collected from subjects on admission prior to randomization to either standard of care (SOC; N = 12) or HPRO + NMES (N = 12) and at 7 days. Untargeted metabolomics were performed for each plasma sample. Sparse partial least squared discriminant analysis identified metabolites differentiating each group. Correlation coefficients were calculated between each metabolite and total protein per day and muscle volume. Multivariable models determined associations between metabolites and muscle volume. Unique metabolites (18) were identified differentiating SOC from HPRO + NMES. Of these, 9 had significant positive correlations with protein intake. In multivariable models, N-acetylleucine was significantly associated with preserved temporalis [OR 1.08 (95% CI 1.01, 1.16)] and quadricep [OR 1.08 (95% CI 1.02, 1.15)] muscle volume. Quinolinate was also significantly associated with preserved temporalis [OR 1.05 (95% CI 1.01, 1.09)] and quadricep [OR 1.04 (95% CI 1.00, 1.07)] muscle volume. N-acetylserine and β-hydroxyisovaleroylcarnitine were associated with preserved temporalis or quadricep volume. Metabolites defining HPRO + NMES had strong correlations with protein intake and were associated with preserved muscle volume.
Topics: Humans; Male; Female; Middle Aged; Subarachnoid Hemorrhage; Diet, High-Protein; Muscle, Skeletal; Metabolomics; Muscular Atrophy; Electric Stimulation Therapy; Aged; Metabolome; Dietary Supplements
PubMed: 38956192
DOI: 10.1038/s41598-024-64666-5 -
Scientific Reports Jul 2024Postural sway has not been investigated before or after a neck exercise intervention in individuals with chronic whiplash-associated disorders (WAD). The aim of the...
Postural sway has not been investigated before or after a neck exercise intervention in individuals with chronic whiplash-associated disorders (WAD). The aim of the study was to investigate postural sway in individuals with chronic WAD grades 2 and 3: (a) compared with healthy matched controls at baseline; (b) after three months of neck-specific exercise and (c) to investigate the correlation between postural sway with self-reported dizziness during motion and balance problems/unsteadiness. This is a longitudinal prospective experimental case-control intervention study. Individuals with WAD (n = 30) and age- and gender-matched healthy volunteers (n = 30) participated. Postural sway was assessed using an iPhone application. Measurements were carried out at baseline, and for those with WAD a second measurement was performed at the three-month follow-up when neck-specific exercise intervention ended. The WAD group performed significantly worse than the healthy group in both pathway and ellipse area double stance eyes closed at baseline (main outcome), but not at the three-month follow-up. The WAD group significantly improved after rehabilitation in both pathway double stance eyes closed and pathway single stance eyes open. The correlation between postural sway and self-rated dizziness during motion and balance problems was low to moderate. One may conclude that postural sway was improved after a neck-specific exercise programme. The study results strengthen earlier findings that individuals with WAD have worse balance outcome when they have to rely on neck proprioception (eyes closed). The study results may be important for the development of improved rehabilitation methods for WAD.
Topics: Humans; Male; Female; Whiplash Injuries; Postural Balance; Adult; Case-Control Studies; Longitudinal Studies; Exercise Therapy; Middle Aged; Prospective Studies; Dizziness; Neck; Chronic Disease
PubMed: 38956135
DOI: 10.1038/s41598-024-66176-w