Mobile Subthreshold Exercise Program (MSTEP) for concussion: study protocol for a randomized controlled trial

Abstract

Background Subthreshold exercise, defined as aerobic exercise below the level that causes symptoms, has been utilized as a treatment for youth with persistent postconcussive symptoms (PPCS), but there is currently little evidence to guide use. In addition, prior studies of exercise for PPCS have all required multiple in-person visits. We developed a virtual approach for delivering subthreshold exercise to youth with PPCS called the Mobile Subthreshold Exercise Program (MSTEP), and we have now been funded to conduct a large national randomized controlled trial (RCT) to test its efficacy for reducing concussive symptoms and improving health-related quality of life. Methods This investigation is an RCT comparing MSTEP to an active control. We will recruit 200 adolescents 11–18 years old with postconcussive symptoms persisting for at least 1 week but less than 1 year. Youth will be randomized to receive either 6 weeks of subthreshold exercise (MSTEP) or a stretching condition (control). Youth and parents will complete surveys of concussive symptoms at baseline, weekly during the intervention, and at 3 and 6 months. The primary outcomes will be trajectory of concussive symptoms and health-related quality of life over the 6 months of the study. Secondary outcomes will include depression, anxiety, and sleep quality. We will also assess potential mediators of treatment effects including moderate-vigorous physical activity and fear avoidance of concussive symptoms. Discussion This multisite RCT of MSTEP will provide vital information regarding the efficacy of a virtually delivered subthreshold exercise program for youth with PPCS, and insight regarding potential mediators of treatment effects, including objectively measured physical activity and fear avoidance of concussive symptoms. Trial registration ClinicalTrials.gov NCT04688255. Registered on December 29, 2020.

The landscape of decentralized clinical trials (DCTs): focusing on the FDA and EMA guidance

“…The decentralized elements used in the identified DCT cases were consistent with the patient safety and data integrity. In the identified DCT cases, most interventions showed low risk and were easy to implement [ 23 24 ]. The indications for the drug-related DCT cases were mainly chronic or prophylactic conditions that did not require urgent management [ 25 26 ].…”

Remote exercise classes are associated with better quality of life in people with Parkinson’s during the Covid-19 pandemic.

“…Simple lifestyle strategies such as activity and exercise can have specific positive effects on PD symptoms, thereby contributing meaningfully to the QOL of PwP in numerous ways. 6 Classical face-to-face exercise programs and regimes have been shown to reduce the burden of progressive PD symptoms, [7][8][9] improve non-motor symptoms 10 and enhance overall QOL in PwP. 11 Furthermore, exercise has been shown to confer positive effects on symptoms in newly-diagnosed PD patients, 8 and long-term studies have shown that regular activity and exercise levels can also reduce a person's lifetime risk of developing PD.…”