ProtoFlex Supporting NIHR-Funded COPD Balance Trial at Teesside University

Teesside University

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ProtoFlex has been commissioned by Teesside University as the trial management platform for B-PuRe — a £1.1 million NIHR Advanced Fellowship–funded pilot randomised controlled trial investigating balance training as a falls prevention intervention for people with Chronic Obstructive Pulmonary Disease (COPD).

Led by Professor Samantha Harrison at Teesside University, B-PuRe (Balance Training in Pulmonary Rehabilitation) addresses a significant but underserved clinical problem: people with COPD experience falls at four times the rate of healthy peers, driven by muscle weakness, poor balance and reduced activity — yet balance training has historically been overlooked within pulmonary rehabilitation programmes.

Beyond a Trial Database

Following a competitive tender process, ProtoFlex was selected by Teesside University to deliver a trial management system — one that could handle a level of complexity that a simple database approach could not. The B-PuRe trial involves structured longitudinal data collection across defined timepoints, randomisation, and the need to collect structured feedback from the exercise trainers delivering the intervention in the field.

ProtoFlex's response was to do what the platform does best: model the problem as a pathway.

Rather than building a flat data store, the B-PuRe trial has been implemented as a ProtoFlex clinical pathway with four discrete timepoints — mapping each participant's journey through the trial from enrolment through to final follow-up. Each timepoint defines the data to be captured, the assessments due, the actions required and the participant's current status within the trial, giving the research team a live longitudinal view of the entire cohort rather than a disconnected series of data entry screens.

Demonstrating Platform Versatility

The B-PuRe deployment is a meaningful proof of ProtoFlex's versatility. The platform's core model — configurable pathways, structured data collection, patient and participant engagement, and flexible workflow automation — translates directly from routine NHS clinical care into the clinical research environment.

The same tools used to manage patients through a sickle cell disease care pathway or an IBD monitoring programme are here managing research participants through a rigorous pilot randomised controlled trial. The same engagement module used to collect patient-reported outcomes in a clinical service is here collecting fidelity data from exercise trainers in the community — a repurposing that required no additional platform development, only configuration.

For NHS trusts and academic institutions looking for a flexible trial management solution that can handle both simple data collection and complex longitudinal study designs, B-PuRe demonstrates that ProtoFlex is a credible option — without the overhead of purpose-built trial management software.

Samantha L Harrison (NIHR Advanced Fellowship, NIHR300856) is funded by the NIHR for this research project. The views expressed are those of the author(s) and not necessarily those of the NIHR, NHS or the UK Department of Health and Social Care.