Monitoring physical rehabilitation is an essential component of patient recovery after knee arthroplasty. Monitoring can be remote, or clinic based. In India, unsupervised home-based physical rehabilitation is a common practice, but there is a lack of evidence to demonstrate the effectiveness of remote monitoring. Therefore, we developed and piloted a mobile application (TeleREhabilitation after knee ArThroplasty app) based on behaviour design thinking to support the recovery period. This trial aims to compare the effectiveness, acceptability, cost and safety of this app-supported home-based intervention against usual care using an open label, 1:1 individual randomised superiority trial at two tertiary care hospitals in India.
Consecutive adults undergoing partial or total, unilateral or bilateral knee arthroplasty who can use a smart phone will be invited to participate in this trial. Consenting individuals will be randomised to either an app-supported intervention or a usual home-based rehabilitation which typically consists of provision of oral or written instructions at discharge and follow-up check-up with the surgeon or physiotherapist at their discretion or as per individual need. We aim to recruit 300 individuals over a period of eighteen months. The primary objective is to compare patient-reported knee function between the two groups at 3 and 6 months postsurgery. Secondary objectives are to compare patient-reported outcomes (pain and activity), performance-based outcomes (lower limb strength and knee function), resource utilisation and quality of life. Fidelity of implementation, end-user experiences and challenges in implementing this intervention will be measured using both quantitative and qualitative methods. Quantitative data will be analysed in Stata, and group comparisons will be done using mixed effect linear regression. A mixed-methods approach will be used to analyse and interpret the process evaluation data. A modified intention-to-treat approach will be taken, which includes all those who were randomised irrespective of their adherence to trial protocol if they had at least one follow-up visit after enrolment.
The protocol has been approved by the ethics committees of the sponsor institute (The George Institute for Global Health) and the two clinical sites (All India Institute for Medical Sciences, Delhi & Indraprastha Apollo Hospitals, Delhi). The results will be disseminated via peer-reviewed publications, conference presentations and via plain language newsletters to the trial participants.
CTRI/2024/06/068838.
by Annur Ferdous, Munira Jahan Raisa, Md Hijbullah, Nafiz Imtiaz Siam, Shatabdy Barua Trisha, Sadia Biswas Mumu, Md Aminul Haque, Javed Ibne Hasan, Muhammed Mahfuzur Rahman, Md Shaki Mostaid
Background/ObjectivesObesity is a chronic metabolic disorder, and its prevalence in Bangladesh is increasing at an alarming rate. Previous reports have suggested a significant association between Vitamin D receptor (VDR) gene polymorphisms and obesity, but with inconsistent results. The purpose of our study was to investigate the association between two single-nucleotide polymorphisms (SNPs) (Apal, rs7975232, and Taql, rs731236) of the VDR gene and the risk of obesity in the Bangladeshi population. Moreover, we looked at serum VDR levels and serum 25-hydroxy vitamin D levels in people with obesity (n = 124) and healthy controls (n = 126).
MethodsGenotyping was performed using Polymerase Chain Reaction-Restriction Fragment Length Polymorphism (PCR-RFLP). General linear model and multivariate logistic regression analysis were used to calculate the adjusted odds ratio (OR) along with 95% confidence intervals (CI) and P-values.
ResultsSerum VDR level was downregulated in people with obesity compared to healthy controls (P A) polymorphism, the CA Heterozygous genotype carried a 1.93-fold higher risk of developing obesity (OR=1.93, 95% CI = 1.10–3.41, P = 0.023). On the contrary, for TaqI, rs731236 (T > C), no significant association was found for both heterozygous and mutant homozygous genotypes.
ConclusionWe report the downregulation of serum VDR levels and serum 25-hydroxy vitamin D levels in people with obesity. Moreover, a polymorphism of Apal (rs7975232 C > A) in the VDR gene increases the risk of developing obesity in the Bangladeshi population.