Protocol for the HIT-Stroke Trial 2 randomized controlled trial: Moderate-intensity exercise versus high-intensity...

Current practice guidelines recommend moderate to vigorous intensity locomotor training to improve walking outcomes in chronic stroke. However, these intensities span a wide range, and the lack of specificity may lead to under-dosing or over-dosing of training intensity. Recent evidence indicates that vigorous intensity locomotor training improves walking outcomes significantly more than moderate intensity. Although, previous studies have not been powered to rule out the possibility of meaningful risk increases or negligible benefit with vigorous versus moderate intensity, nor have they been designed to compare sustained effects after training ends. In addition, small subgroup analyses have suggested that individuals with severe walking limitations (speed <0.4 m/s) may require vigorous training intensity to have meaningful benefit, but this has not been prospectively tested with a sufficient sample. The results of this study are expected to provide more specific guidance for optimizing locomotor training intensity and walking outcomes in chronic stroke.

In this single-blind, 3-site, randomized trial, 156 chronic (>6 months) stroke survivors will be allocated to 36 sessions (3 times a week for 12 weeks) of either high intensity interval or moderate intensity continuous locomotor training. Eligible participants have residual walking limitations from stroke and can walk without continuous physical assistance from another person. At least 52 participants will have severe baseline walking speed limitations. Outcomes are assessed at baseline, after 4 weeks, 8 weeks, 12 weeks (POST), and 3 months after completing training. The primary outcome is walking capacity (6-minute walk distance). Secondary outcomes include comfortable and fast gait speed, aerobic capacity, fatigue, balance confidence, quality of life, and motivation for exercise. Statistical analyses will compare outcome changes and adverse events between treatment groups, and will include subgrouping by walking limitation severity.

This study will provide important new information to guide greater specificity and individualization of locomotor training intensity in chronic stroke.

ClinicalTrials.gov NCT06268041 ; Registration Date: 2024-02-12.