Digital Platform Exercise Therapy
Although exercise therapy has an important role on cancer patient’s functional recovery, physiological improvement, and treatment reaction, there are some structural problem in validating this through using strict clinical trial. Previous exercise clinical trials used hospital-based models, which caused frequent visit, time and cost, and geographical limitation. These limitations yielded low participation rate and variety. Therefore, the researchers developed Digital Platform for Exercise (DPEx). DPEx is developed to remotely process every research procedures through integrating home-based exercise therapy, remote cardiovascular fitness test, digital biosignals monitoring, and eConsent. This research is to explain development process of DPEx platform and evaluate execution possibility in 3 independent cancer patient cohorts.
For study design, three phases were conducted: Phase 0a (Development Study) researched on 3 breast cancer survivors; Phase 0b (Proof-of-Concept trial) researched on 13 treatment-naïve solid tumor patients; Phase 1a (Dose-Finding Trial) researched on 53 localized prostate cancer patients. The DPEx platform integrated remote exercise therapy, cardiorespiratory fitness testing, digital physiological monitoring, and electronic consent with digital recruitment in a fully decentralized model. Exercise therapy was delivered via home-based treadmills with real-time video supervision, allowing individually prescribed sessions of up to 450 minutes per week and continuous remote safety monitoring, while fitness testing used the Balke-Ware incremental protocol targeting 80% of age-predicted HRmax to guide exercise prescription. Wearable devices tracked activity, heart rate, blood pressure, and body composition, complemented by continuous glucose monitoring, dietary tracking, and remote blood and stool collection for high-resolution physiological profiling. Electronic consent and EHR-based screening enabled fully remote enrollment, and feasibility was evaluated through connectivity success, exercise and device adherence, safety, and comparisons of patient time, cost, and overall efficiency versus traditional site-based models.
DPEx platform has shown high feasibility and adaptability on every research stage. In Phase 0a development cohort, exercise session digital connect success rate was 100%, followed by exercise adherence(94%) and wearable device use adherence (85%) and no sincere SAE occurred. In Phase 0b Proof-of-Concept, 13 post-treatment cancer patients participated and resulted exercise adherence (87%), continuous blood sugar monitoring adherence (86%), dietary record adherence (75%), and remote blood and stool collect completeness rate (94% , 90%), respectively. Total patients time was 34 hours, compared to previous hospital based model (81 hours), marked by no expenses by patients. Lastly, in Phase 1a Level-Finding, 53 prostate cancer patients participated and resulted exercise adherence (88%), device adherence maintenance, no irregular reaction. It proves that DPEx can stably execute high-precision exercise treatment and comprehensive physiology monitoring in remote environment.
The DPEx platform effectively addressed major barriers of traditional site-based exercise trials. It overcame geographic limitations, time and cost burdens, and difficulties in delivering high-frequency exercise prescriptions, while providing personalized exercise doses safely through real-time video supervision and wearable monitoring. Even in remote high-volume exercise programs reaching up to 450 minutes per week, connectivity and adherence remained high, and patients living far from the research center were able to participate, improving recruitment diversity. Unlike conventional mobile health or hybrid remote platforms, DPEx allowed precise control of exercise intensity and volume, with real-time adjustments in response to abnormal physiological signals, enhancing the quality of clinical data. In addition, the platform reduced patient time and costs and improved research efficiency, providing substantial advantages for trial design and execution.
The DPEx platform demonstrated high feasibility, safety, and adherence in fully digital, decentralized exercise trials. Remote, structured exercise with continuous physiological monitoring enabled precise, personalized prescriptions while reducing patient burden and cost. DPEx offers a scalable model for future exercise oncology and decentralized clinical research, supporting diverse interventions and long-term high-resolution data collection.
출처: https://www.nature.com/articles/s41746-024-01288-1