The first objective was to establish the feasibility of conducting a definitive trial to evaluate the effectiveness of mobility and strength training with or without protein supplements for pre-frail/frail older people with low protein intake. The second objective was to finalise outcome measures for a definitive trial.
Multicentre feasibility randomised controlled trial.
Four National Health Service (NHS) community trust physiotherapy departments. We recruited via clinical caseloads, an existing cohort study and community advertising. Participants were adults aged ≥60 years, frail or pre-frail, reporting walking difficulties or slow walking and low protein intake (
All participants undertook two times a week mobility and strength training supported by a physiotherapist for 24 weeks. Half of the participants were randomised (1:1) to receive 24 weeks of daily protein supplements to increase protein intake up to 1.6 g/kgBW/day.
Feasibility outcomes assessed recruitment, intervention fidelity, adherence, tolerance and study retention.
We assessed clinical data collection at baseline and 5–8 month follow-up including the short physical performance battery (SPPB), 6 min walk test (6MWT) and participant-reported outcomes. Outcome assessors were blinded.
All participants were analysed in the groups as randomised provided they were not withdrawn from the study before their treatment started and contributed outcome data (modified intention to treat). Our primary feasibility and secondary outcome measures were summarised using descriptive statistics such as mean and SD, median and IQR or counts with percentages. Secondary objectives were exploratory, and mean between group differences at follow-up were estimated for each continuous outcome using linear regression models adjusted for baseline outcome score and frailty status, and presented with associated 95% CIs.
Initially, recruitment focused on existing caseloads, but patients were more unwell and disabled than anticipated and ineligible. No participants were recruited from the cohort. A community recruitment strategy was implemented. We screened 952 older adults and 20 participants were randomised. We ran out of time to reach our target.
We achieved good intervention fidelity for both interventions. The median number of exercise sessions completed was 10.5/16 (IQR 7–13). Six participants received supplements which they tolerated well and took regularly. 14 participants (70%) attended follow-up assessments with no difference in retention between arms.
The median age of participants was 76 years (IQR 68.5–80.0) and 15/20 (75%) were frail. All clinical outcomes showed a trend towards larger improvements in the exercise and protein arm, but these were not statistically significant. For example, SPPB scores (mean difference 0.93, 95% CI (–2.70 to 4.56)) and 6MWT (mean difference 41.92 m, 95% CI (–39.05 to 122.89)) were both higher in the exercise and protein arm compared to control.
The study was not feasible based on the original protocol. Recruitment was the biggest challenge. We established a more efficient route to recruitment (community advertising) which requires further refinement. Clinical outcomes consistently favoured the exercise and protein group, which should be interpreted cautiously but suggest this question is worthy of further investigation.
Women with high-risk pregnancies (eg, pre-eclampsia, imminent preterm birth) are often hospitalised due to the need for foetal and maternal monitoring. They are monitored for 30–45 min up to three times a day with conventional cardiotocography (CTG). In the meantime, they reside at the hospital, but the foetal status is not monitored. Continuous foetal monitoring is currently not recommended using CTG, due to the potential temperature rise from consistent exposure to ultrasound waves. For safe 24/7 monitoring, newly developed devices using non-invasive electrophysiological cardiotocography (eCTG) instead of conventional CTG offer a promising alternative. Previous research into eCTG has shown favourable results in monitoring foetal heart rate throughout both pregnancy and labour. This study aims to investigate the effect of implementing continuous antepartum eCTG monitoring in hospitalised high-risk pregnancies on perinatal and maternal outcome.
In this single centre prospective cohort intervention random sampling study, eligible women will be included on the Obstetric High Care of Máxima MC Veldhoven, the Netherlands. In total, 511 pregnant women with a singleton pregnancy between 23+0 and 32+0 weeks of gestation requiring hospitalisation will be recruited. Eligible women will be prospectively included in the cohort receiving standard treatment: intermittent CTG monitoring. From these women, a random sample of the prospective cohort will be offered a new monitoring method: 24/7 eCTG monitoring. For the eCTG monitoring, a wireless abdominal electrode patch, the Nemo Foetal Monitoring System will be used. Additional data from a historical cohort (2014–2019) of 1400 women receiving standard treatment will be included. Perinatal and maternal outcome, along with satisfaction levels of both patient and caregivers, will be compared between groups.
The study is registered on 18 October 2022 to the Central Committee on Research Involving Human Subjects (NL82869.015.22) via https://www.toetsingonline.nl/to/ccmo_monitor.nsf/conceptabr?OpenForm and approved by the Medical Ethics Committee of Máxima MC (W22.070) on 7 November 2023. Results of the study will be disseminated in peer-reviewed scientific journals and conference presentations.
Variations in mental health and sexual and reproductive health (SRH) outcomes of girls/women (cisgender and transgender) and gender-diverse (nonbinary, Two-Spirit, gender fluid, agender, queer, gender neutral) youth with intersectional identities exist and have largely been ignored in the literature. There is a lack of information on how these health services meet the health needs of girls/women and gender-diverse youth with intersectional identities and the quality of such services. The objective of this global realist review is to identify how, why, for whom, in what contexts and to what extent mental health and SRH services meet the health needs of girls/women (cisgender and transgender) and gender-diverse youth (10–25 years) with intersectional identities.
The protocol has been registered with PROSPERO and will follow Realist and Meta-narrative Evidence Syntheses Quality Standards for Realist Reviews. We will identify the programme theory and implementation determinants of mental health and SRH services for girls/women (cisgender and transgender) and gender-diverse (nonbinary, Two-Spirit, fluid, agender, queer, gender neutral) youth (10–25 years). The scope of the review will be defined in the first stage and will include consultations with youth Advisory Group members and initial programme theory development. An iterative search of scholarly bibliographic databases (MEDLINE, Embase, APA PsycInfo, CINAHL, Web of Science, IBSS) in addition to a grey literature search will take place in the second stage. The third stage will include evidence extraction and synthesis. In the final stage, the narrative will be developed and refined in consultation with Youth Advisory Group members, and findings will be disseminated.
The study was approved by the Research Ethics Board at the Centre for Addiction and Mental Health (2023/153). Findings will be disseminated through peer-reviewed publications, youth-friendly materials and webinars and national and international conferences.
CRD42024532422.