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Infection prevention and control measures during the COVID-19 pandemic in sub-Saharan Africa: a multinational cross-sectional study

Por: Böff · L. · Momou · K. J. · Rafamatanantsoa · J. F. · Mosala · F. · Reichert · F. · Boone · I. · Toure · S. F. · Pyana · P. · Ravaoarisoa · L. · Nduenga · S. · Behnke · A.-L. · Conradie · A. · Ferchichi · K. · Fuchs · M. · Müller · S. · Ochu · C. L. · Ortu · G. · Pozo-Martin · F. · Sch
Objectives

To assess the implementation of infection prevention and control (IPC) measures and associated factors in healthcare in low-resource settings during the COVID-19 pandemic.

Design

Multinational cross-sectional study.

Setting

The study was conducted from February to November 2022 in Côte d’Ivoire, Democratic Republic of Congo, Madagascar and Nigeria.

Participants

A total of 6749 healthcare workers (HCWs) at 324 healthcare facilities (HCFs) were enrolled from different levels of care and types.

Primary and secondary outcomes

Standardised HCW and HCF questionnaires assessed COVID-19-related exposures and IPC measures and descriptive analyses were conducted overall and by country and HCF. Partial proportional odds models were used to assess factors associated with HCW compliance to hand hygiene and mask wearing.

Results

Among 324 HCFs, the reported presence of IPC programmes ranged from 51.4% (n=111) at primary non-hospitals to 83.3% (n=18) at tertiary HCFs. More than half reported no patient or HCW screening (57.4%, n=186). Only 19.8% (n=64) reported handrub at point of care in every room. Among 6749 enrolled HCWs, 54.0% were working in high-risk patient care. More HCWs reported sufficient availability of masks (62.7%, n=4231) compared with respirators (28.5%, n=1926). HCW compliance with hand hygiene and mask wearing, respectively, was improved by presence of an IPC programme (OR: 1.3, 95% CI 1.2 to 1.5; OR: 1.4, 95% CI 1.2 to 1.6), IPC training received by the HCW (OR: 1.5, 95% CI 1.3 to 1.7; OR: 1.3, 95% CI 1.2 to 1.5) and availability of handrub and masks, respectively (OR: 5.9, 95% CI 4.1 to 8.4; OR: 2.3, 95% CI 2.0 to 2.7).

Conclusions

We conducted a large survey including HCFs across levels of care and type in urban and rural regions in sub-Saharan Africa. Critical gaps in IPC programmes and access to IPC equipment during the COVID-19 pandemic hindered HCW compliance with recommended IPC practices. To improve general infection control and pandemic preparedness in low-resource settings, continued focus on strengthening IPC programmes and ensuring access to materials/equipment is essential.

Delivery strategies for malaria chemoprevention in the post-discharge management of children hospitalised with severe anaemia or severe malaria: protocol for a cluster randomised controlled implementation trial in Benin

Por: Accrombessi · M. · Assongba · L. · Khairallah · C. · Chen · T. · Tchehoundje · B. · Dangbenon · E. · Abdoulaye · D. · Vincent · J. P. · Otieno Awori · J. · Luty · A. J. F. · Hoyt · J. · McCoy · A. · Worrall · E. · Briand · V. · ter Kuile · F. O. · Massougbodji · A. · Hill · J.
Introduction

Children discharged after in-hospital treatment for severe anaemia or severe malaria in sub-Saharan Africa remain at high risk of readmission and death, particularly in malaria-endemic settings where recurrent infections are common. Post-discharge malaria chemoprevention (PDMC) has demonstrated substantial reductions in mortality and hospital readmissions and is now recommended by the WHO. However, optimal PDMC delivery strategies, via existing health systems, that optimise adherence remain unclear, particularly in West Africa where implementation and evidence of impact on clinical outcomes are limited. This trial aims to determine the effectiveness of different PDMC delivery strategies and adherence support mechanisms in optimising completion of PDMC courses. Secondary objectives include assessing clinical outcomes (readmissions, outpatient visits, mortality), evaluating health system linkage mechanisms and examining the acceptability and feasibility of the different delivery approaches.

Methods and analysis

A cluster-randomised implementation trial will be conducted in central and southern Benin across urban and rural settings. Clusters, defined as villages within the catchment areas of two referral hospitals, will be randomly allocated (1:1:1) to one of three arms: (A) facility-based drug distribution (all courses) at discharge with community health worker (CHW) home visit reminders; (B) monthly community-based drug delivery by CHWs combined with phone reminders; and (C) dispensing all courses to caregivers at discharge without adherence support (control). Eligible participants are children under 10 years hospitalised with severe anaemia or severe malaria and clinically stable at discharge. All participants should receive three courses of dihydroartemisinin–piperaquine at weeks 2, 6 and 10 post-discharge and will be followed for 14 weeks. The primary endpoint is incomplete adherence to the full PDMC regimen (3 courses/9 doses). Secondary endpoints include all-cause and malaria-specific readmissions, outpatient visits and mortality. Quantitative outcomes will be analysed using mixed-effects regression models under an intention-to-treat approach. Qualitative methods will assess acceptability and feasibility among caregivers, providers and policymakers.

Ethics and dissemination

Ethical approval was received from the institutional review boards of the Benin Institute of Applied Biomedical Sciences and Liverpool School of Tropical Medicine. Trial findings will be disseminated to national and international stakeholders through meetings, peer-reviewed publications and major conferences to inform PDMC policy, implementation guidelines and global malaria scale-up efforts, particularly through engagement with the World Health Organization and major malaria funding partners

Trial registration number

ClinicalTrials.gov, NCT06601712, registered on 14 September 2024 (https://clinicaltrials.gov/study/NCT06601712); and Pan African Clinical Trials Registry, PACTR202411682724094, registered on 5 November 2024 (https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=31962).

Women in healthy transition deep phenotyping cohort study protocol (KiSO-DP): a within-participant multidisciplinary longitudinal cohort study across the menopausal transition

Por: Tamariz-Ellemann · A. · Kleis-Olsen · A.-S. · Andersen · A. B. · Thomsen · L. B. · Rocha · M. P. · Frydenholm · J. F. · Jensen · J. S. · Loekkegaard · E. C. L. · Hellsten · Y. · Hybholt · M. · Gliemann · L.
Background

Cardiovascular disease risk accelerates in women after the menopausal transition, coinciding with the cessation of endogenous oestrogen production. The accompanying decline in vascular function is considered a key driver of this shift. However, longitudinal studies investigating the impact and time course of changes in cardiovascular and skeletal muscle function during the menopausal transition and in the subsequent years are warranted.

Objectives

The Women in Healthy Transition (KiSO) Deep Phenotyping (DP) study is a multidisciplinary prospective longitudinal cohort study with the objective to determine cardiovascular changes from the late reproductive stage through 20 years of postmenopause. The primary outcome is quantification of endothelium-dependent vascular function. Secondary outcomes include evaluating endothelium-independent vascular function, conduit artery endothelial function, mitochondrial function, circulating skeletal muscle vascular markers and sociological factors. The overall aim is to provide deep mechanistic, longitudinal insight into menopause-related vascular ageing to inform future cardiovascular disease prevention strategies in women.

Methods

200 healthy women will be examined at the late reproductive stage and at 1, 3, 5, 10 and 20 years postmenopause. At each test round vascular function is evaluated using invasive intra-arterial infusion protocols, including acetylcholine and epoprostenol infusions, as well as flow-mediated dilation. Additional measures include arterial blood pressure, arterial compliance, echocardiography, cardiorespiratory fitness, whole-blood rheology, dual-energy X-ray absorptiometry-derived body composition, circulating reproductive and cardiometabolic biomarkers, skeletal muscle biopsies for assessment of mitochondrial capacity and proteins related to skeletal muscle and cardiometabolic health. Menopausal staging is determined using Stages of Reproductive Aging Workshop (STRAW)+10 criteria supported by follicle-stimulating hormone, anti-Müllerian hormone concentrations and antral follicle count.

Ethics and dissemination

The study is conducted in accordance with the Declaration of Helsinki and has been approved by the regional ethics committee: Ethics Committee of Copenhagen (H-22025286) and is registered with ClinicalTrial.gov (NCT05647876). Findings from the study will be disseminated through publications in peer-reviewed scientific journals, presentations at national and international conferences and through PhD theses. The results are expected to provide novel insights into the development of vascular and skeletal muscle function across the menopausal transition and may contribute to future strategies for prevention of cardiovascular disease in women.

Trial registration number

NCT05647876.

Hauora Manawa mo nga Kaumatua me nga Whanau: a co-designed community-based cohort study of cardiovascular health among older Maori in Canterbury, New Zealand--a study protocol

Por: Pearson · A. · Cunningham · E. · Kane · J. · Troughton · R. W. · Pearson · J. F. · Lewis · L. K. · Woodcock · E. · Pemberton · C. · McKerchar · C. · Patu · M.
Introduction

Cardiovascular disease remains a leading cause of preventable mortality in Aotearoa New Zealand (NZ), with Māori continuing to experience earlier onset, higher hospitalisation rates and greater mortality than non-Māori. Despite this inequity, community-based data describing cardiac structure, function and circulating cardiovascular biomarkers in older Māori are very limited, particularly for those over 65 years. The Hauora Manawa mō ngā Kaumātua me ngā Whānau (Heart Health of Older Māori and Families; Kaumātua Manawa) study aims to examine associations between ethnicity and age on cardiac structure, function and plasma cardiovascular biomarkers in Māori and to evaluate the suitability of current clinical reference standards.

Methods and analysis

Kaumātua Manawa is a community-based, co-designed study comprising a baseline assessment of cardiac structure, function and biomarkers, combined with prospective ascertainment of hospitalisation, all-cause mortality, pharmaceutical dispensing and clinical laboratory outcomes via ongoing linkage to national administrative health data held by the Ministry of Health and Te Whatu Ora | Health NZ. The study is conducted in partnership with Māori communities in Canterbury, NZ, with study clinics conducted at marae to ensure cultural safety for participants. Adults aged ≥18 years are recruited using convenience sampling, with a primary focus on Māori aged ≥65 years. Participants undergo nurse assessment (demographics, medical history, cardiovascular risk factors), 12-lead ECG, comprehensive transthoracic echocardiography following American Society of Echocardiography guidelines and non-fasting blood sampling. Biomarkers include N-terminal pro-B-type natriuretic peptide, high-sensitivity troponin T, growth differentiation factor-15 and lipoprotein(a). Descriptive statistics will summarise cardiac measures overall and by marae. Associations between biomarkers and demographic and clinical variables will be examined using regression modelling. Echocardiographic parameters indexed according to international and NZ-specific recommendations will be compared with existing NZ European cohorts. This methodology paper uses the principles of the CONSolIDated CritERia for Strengthening the Reporting of Health Research Involving Indigenous Peoples statement (CONSIDER).

Ethics and dissemination

Ethics approval has been obtained from the NZ Health and Disability Ethics Southern Committee (2022 EXP 11434), and the protocol is registered at the Australian NZ Clinical Trials Registry. The study is governed by a dedicated Māori Governance Rōpū (Group) to ensure alignment with tikanga Māori (Māori protocols) and community priorities. Meetings will be conducted with participating marae and communities to discuss findings prior to publication. Results will be disseminated through open-access peer-reviewed publications and via presentations.

Trial registration number

ACTRN12626000348358.

Supporting adherence to adjuvant CDK4/6 inhibitors in women with early breast cancer (SWEET-PLUS): protocol for a multicentre UK study using qualitative and co-development methods

Por: Teow · P. · McGeagh · L. · Cain · H. · Todd · A. · Rehman · F. · Brett · J. · Levitt · N. · Turner · M. · Stewart · S.-J. F. · Hunt · E. · Terrado · H. · Watson · E. · Sharp · L.
Introduction

Breast cancer is the most common cancer in women in the UK. For women who have early-stage oestrogen-receptor positive (ER+ve) disease, daily oral adjuvant endocrine therapy reduces risk of recurrence. Recently, CDK4/6 inhibitors, a form of biological therapy, have been approved for use alongside endocrine therapy. However, trial data suggest there may be challenges with adherence to CDK4/6 inhibitors. This study aims to explore the experiences of adherence and support needs of women who have been prescribed CDK4/6 inhibitors for early ER+ve breast cancer. It will also co-develop an intervention to support women with adherence to these drugs alongside endocrine therapy through an evidence-based, theory-informed and patient-centred approach.

Methods and analysis

The SWEET-PLUS study has three phases. Phase I uses semi-structured interviews or focus groups to explore the experiences of women with early breast cancer who have been prescribed CDK4/6 inhibitors. It will also explore their support needs and experiences of adherence. Phase II involves interviews or focus groups with healthcare professionals who support CDK4/6 inhibitor prescription and associated care to understand the existing support and unmet needs. Phase I and II findings will inform phase III, which comprises workshops and user testing interviews to co-develop an intervention to support women with adherence to CDK4/6 inhibitors alongside endocrine therapy. This will be delivered as an additional module prototype designed for future integration into the existing HT&Me intervention, which supports women with adherence to endocrine therapy.

Data from phases I and II will be analysed using a framework approach-based thematic analysis. Phase III data will be analysed through content analysis.

Ethics and dissemination

SWEET-PLUS received ethical approval from the National Health Services (NHS) Health Research Authority (Cambridge East Research Ethics Committee (25/EE/0220)). Research findings will be disseminated through peer-reviewed journal articles and via international and national conferences. Further dissemination will be guided by patient and public involvement.

Association between inpatient AUDIT-C alcohol screening scores and postoperative outcomes: a retrospective cohort study

Por: Chen · T. · Fernandez · A. C. · Evilsizer · S. · Chan · C.-L. · Gunaseelan · V. · Waljee · J. F. · Bicket · M. C.
Objectives

To evaluate whether alcohol use severity, as measured by the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C), is associated with postoperative complications, hospital utilisation and opioid prescribing among adult surgical inpatients.

Design

Retrospective cohort study.

Setting

Single tertiary academic hospital in the USA, using data from inpatient surgical admissions between April 2021 and September 2023.

Participants

Adult patients (≥18 years) admitted for inpatient surgery with a completed AUDIT-C screening during their admission.

Measures

AUDIT-C scores were categorised as at-risk (≥5 for men, ≥4 for women) or low risk (other non-zero scores). Patients with AUDIT-C scores of 0 were described in the cohort but excluded from the primary comparative analyses to account for potential J-shaped associations between abstinence and health outcomes. The primary outcome was a composite of surgical complications, emergency department visits, hospital readmissions or mortality within 30 days of surgery. Secondary outcomes included hospital length of stay and postoperative opioid prescribing from discharge through 6 months. Univariable and multivariable logistic regression models were used to evaluate associations between AUDIT-C scores and postoperative outcomes. Additional analyses included Kaplan-Meier survival analysis, receiver operating characteristic curves and feature importance modelling.

Results

9538 (31.1%) of 30 708 eligible surgical patients completed the AUDIT-C, and screening was more common among younger, healthier patients. Among screened patients, 5440 (57.0%) were female and 7405 (77.6%) identified as non-Hispanic White. A total of 805 (8.4%) of screened patients reported at-risk alcohol use. The primary outcome, composite adverse postoperative outcomes, occurred in 13.9% of low-risk patients and 14.5% of at-risk patients (p=0.637). In unadjusted analyses, no significant differences were observed between alcohol risk groups for individual postoperative outcomes, including complications, 30-day readmissions, emergency department visits or mortality. Multivariable logistic regression confirmed no association between AUDIT-C category and the primary composite outcome (average marginal effect 0.01, 95% CI –0.02 to 0.03). Median hospital length of stay differed slightly between groups (3.0 days (IQR 4.0) vs 3.0 days (IQR 5.0); p=0.01). In adjusted Cox proportional hazards modelling, at-risk alcohol use was associated with a slightly lower hazard of discharge compared with low-risk alcohol use, corresponding to a modestly longer time to discharge (HR=0.92, p=0.041). Time to readmission did not differ significantly. Opioid prescribing at discharge was similar across groups (58.4% vs 58.9%, p=0.763).

Conclusions

In this real-world surgical cohort, observed AUDIT-C risk category among patients who completed screening was not significantly associated with short-term postoperative outcomes or opioid prescribing. While small differences in length of stay reached statistical significance, their clinical relevance is uncertain. Limitations include limited number of at-risk patients, non-response bias and the absence of standardised follow-up for at-risk patients, which may have contributed to null findings. Future efforts should focus on improving screening through workflow integration, surgical team engagement and follow-up interventions to fully realise benefits from alcohol screening.

Association between GLP-1 receptor agonists and alcohol-related hospitalisations among adults with alcohol use disorder: multi-target trial emulation study

Por: Rodriguez · P. J. · Lusk · J. B. · Mehta · H. B. · Levy · J. F. · Kalogeropoulos · A. P. · Soneji · S. · Do · D. · Holler · E. · Webber · E. · Gluckman · T. · Stucky · N.
Objective

To evaluate the association between use of newer glucagon-like peptide-1 receptor agonists (GLP-1 RAs; semaglutide, tirzepatide) and alcohol-related hospitalisations among adults with alcohol use disorder (AUD) and type 2 diabetes (T2D) or obesity.

Retrospective cohort study using target trial emulation.

Setting

Electronic health record data from a collective of US healthcare systems.

Participants

Adults with AUD and T2D or obesity who started a newer GLP-1 RA (semaglutide or tirzepatide) or a relevant active comparator between 1 January 2018 and 31 December 2024.

Interventions

Initiation of a newer GLP-1 RA compared with an active comparator across four target trials: (1) anti-diabetic medication (ADM) trial, (2) anti-obesity medication (AOM) trial, (3) medications for alcohol use disorder with T2D (MAUD-T2D) trial, and (4) medications for alcohol use disorder with obesity (MAUD-obesity) trial.

Main outcome measures

Time to first alcohol-related emergency department visits or hospitalisation within 1 year of treatment initiation. Non-alcohol-related hospitalisation was assessed as a negative control outcome. Propensity score based methods (weighting and matching) were used to control confounding and Cox proportional hazards models were used to estimate treatment effects.

Results

A total of 40 703 adults met study criteria, including 18 676 in the ADM trial, 9391 in the AOM trial, 8942 in the MAUD-T2D trial and 11 198 in the MAUD-obesity trial. Initiation of a newer GLP-1 RA was associated with a lower hazard of alcohol-related hospitalisation in the ADM trial (HR 0.74, 95% CI 0.62 to 0.89 vs sulfonylureas; HR 0.78, 95% CI 0.65 to 0.92 vs other ADMs), the AOM trial (HR 0.68, 95% CI 0.54 to 0.85 vs other AOMs), the MAUD-T2D trial (HR 0.37, 95% CI 0.29 to 0.46) and the MAUD-obesity trial (HR 0.35, 95% CI 0.26 to 0.47).

Conclusions

Among adults with AUD and T2D or obesity, initiation of newer GLP-1 RAs was associated with a lower observed risk of alcohol-related hospitalisation.

Fun Exercise for Older Adults (FEXO): study protocol for a randomised controlled trial on intrinsic capacity, adherence and motivation

Introduction

Ageing is associated with declines in physical and cognitive function that increase the risk of disability and dependence. Intrinsic capacity (IC), proposed by the WHO, provides a multidimensional framework to assess health in older adults. This study aims to evaluate whether a multicomponent recreational exercise programme (Fun Exercise for Older Adults (FEXO)) improves IC, motivation and adherence compared with a conventional programme (OTAGO).

Methods and analysis

A randomised controlled trial with two groups (2:1 ratio) will be conducted among 120 community-dwelling older adults (≥60 years). Participants will be randomly assigned to FEXO (intervention) or OTAGO (control). Both programmes will consist of 3 weekly sessions for 14 weeks. Primary outcomes: IC, assessed through validated measures (Short Physical Performance Battery, Mini Nutritional Assessment, Mini-Mental State Examination, Cornell Scale for Depression in Dementia and sensory evaluation), motivation (BREQ-3) and adherence rate. Secondary outcomes include body composition, cardiovascular parameters, frailty, cognition and resilience (PRIFOR). Data will be analysed using two-way ANOVA (groupxtime) under an intention-to-treat approach. Effect sizes (p²) and 95% CIs will be reported. Additional analyses (correlation, regression, mediation and moderation) will explore associations and intervention effects.

Ethics and dissemination

Approved by the Ethics Committee of Universidad CEU Cardenal Herrera (Ref. CEEI23/487 and CEEI25/639). Results will be disseminated through peer-reviewed journals and scientific conferences. The findings of this study will contribute to improving evidence-based strategies for promoting healthy ageing and will support the development of more engaging and effective exercise interventions for older adults.

Trial registration number

This study has been prospectively registered at ClinicalTrials.gov (identifier: NCT07133568).

ADNOLA trial: a study-protocol - a randomised controlled trial study comparing adnexal surgery by vNOTES or laparoscopy

Por: Olsson · K. S. · Baekelandt · J. F. · Källen · K. · Matak · L. · Caretto · M. · Wassen · M. M. L. H. · Simoncini · T. · Stuart · A.
Introduction

Adnexal surgery is one of the most common surgeries performed in women. Minimally invasive methods are on the rise globally as they have been shown to decrease surgical morbidity compared with abdominal surgery. Adnexal surgery by vaginal natural orifice transluminal endoscopic surgery (vNOTES) is the latest innovation. It combines the vaginal approach and endoscopy via the vagina. Large pragmatic randomised controlled trials (RCTs) are lacking comparing outcomes after vNOTES and conventional laparoscopy.

Methods and analysis

A multicentre pragmatic RCT aiming to recruit 200 women aged 18 years and above undergoing adnexal surgery for benign disease or prophylactic reasons. Patients will be randomised to vNOTES or laparoscopy. Recruitment will start Q4 2025, and the study is estimated to end 2028.

The primary outcome is postoperative pain. Secondary outcomes are units of postoperative opioid and non-opioid analgesics used, perioperative complications, operation time, postoperative complications, readmission, conversion rate and the surgeon’s experience.

Ethics and dissemination

The national Swedish ethical board at the main centre, Helsingborg Hospital, Sweden, has given ethical agreement (dated 20 March 2025). Before including patients, all centres will require local or national ethical approval. The results of the study will be published in international peer-reviewed journals.

Trial registration number

NCT06964594.

Who gets to deliver in a health facility? An investigation of wealth-based inequities in institutional delivery in Ghana

Por: Atta-Doku · J. F. · Achiam · W. K. A.
Objectives

Institutional delivery under skilled care is essential for reducing maternal mortality. Ghana has expanded maternal health services through policies such as the National Health Insurance Scheme and the free maternal healthcare policy. Inequalities in access to facility-based delivery, however, remain across socioeconomic groups. This study examined wealth-based inequities in institutional delivery and identified maternal and socioeconomic factors associated with facility delivery in Ghana.

Design

A cross-sectional analysis of nationally representative survey data.

Setting

Ghana.

Participants

Data were drawn from the 2022 Ghana Demographic and Health Survey. The analysis included 5855 women aged 15–49 years who had at least one live birth in the 5 years preceding the survey.

Methods

Descriptive statistics were used to summarise participant characteristics, and weighted logistic regression models were applied to identify factors associated with institutional delivery.

Results

84.3% of women delivered in a health facility. Wealth showed a strong gradient effect. Women in the richest wealth quintile had significantly higher odds of institutional delivery compared with those in the poorest quintile (odds ratio (OR) 2.71, p

Conclusion

Socioeconomic and geographic disparities in institutional delivery remain evident in Ghana. Wealth, education, antenatal care attendance and health insurance coverage influence access to facility-based childbirth. Targeted interventions are needed to improve equitable access to skilled delivery services.

Effects of multimodal exercise programme combined with high-protein diet on glycaemic control in older adults with type 2 diabetes mellitus: study protocol for a randomised controlled trial

Por: Sharna · S. Y. · Hossain · K. M. A. · Hero · M. H. · Rahman · M. A. · Rikti · J. F. · Mim · P. B. · Amin · A.
Introduction

Effective management of type 2 diabetes mellitus (T2DM) in older adults requires interventions that address both metabolic control and functional capacity. Exercise improves insulin sensitivity, glucose uptake and cardiometabolic health, while high-protein diets support muscle mass preservation, satiety and glycaemic regulation. Evidence suggests that integrating structured exercise with a high-protein diet may provide additive benefits; however, research evaluating this combined approach in older adults with T2DM, particularly in low-resource settings, is limited. This study aims to determine whether a 12-week multimodal exercise programme combined with a high-protein diet improves glycaemic control and broader health outcomes compared with exercise alone.

Methods and analysis

In this randomised controlled trial (RCT), 140 adults aged ≥60 years with T2DM will be allocated 1:1 to an experimental group (multimodal exercise with high-protein diet, n=70) or a control group (multimodal exercise alone, n=70). All participants will engage in three supervised exercise sessions per week for 12 weeks. Additionally, the experimental group will follow a high-protein diet that provides approximately 30% of total energy from protein, with a 500-kcal daily energy deficit. The primary outcome is glycaemic control, measured by Glycated haemoglobin (HbA1c). Secondary outcomes include anthropometric measures, fasting blood glucose, lipid profile, functional capacity (6-minute walk test) and health-related quality of life Short Form-36 Health Survey (SF-36). All outcomes will be assessed at baseline, postintervention (week 12) and follow-up (week 24). Participants, outcome assessors and statisticians will remain blinded. Intervention fidelity, adherence and safety will be systematically monitored, and final results will be analysed using SPSS (v.26.0). The study will follow ethical standards and comply with Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) guidelines.

Ethics and dissemination

The protocol has been approved by the Institutional Review Board of the Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (Approval No.: PTR-JUST/IRB/2025/09/192404) and registered with the Clinical Trials Registry of India. Findings will be disseminated via peer-reviewed journals, conference presentations and structured knowledge-sharing sessions to inform clinical practice in diabetes management.

Trial registration number: CTRI/2025/08/092509

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