Blood flow restriction combined with functional training and its effects on activities of daily living, balance, and gait stability in Parkinson’s disease: a three-arm pilot randomized controlled trial
Abstract
Background. Gait and postural instability are key determinants of functional independence and fall risk in Parkinson’s disease (PD). Blood flow restriction (BFR) training may provide a high neuromuscular stimulus at relatively low mechanical load, but its added value when embedded within task-oriented functional training in PD remains unclear. Methods. We conducted an assessor-blinded, three-arm, parallel pilot randomized controlled trial. Thirty-three adults with idiopathic PD (Hoehn & Yahr stage 1–3) were randomized 1:1:1 to (i) BFR plus functional training (BFR+Func), (ii) functional training alone (Func), or (iii) control (health education). Training was delivered for 8 weeks (3 sessions/week; ~60 min/session). In BFR+Func, thigh cuffs were applied intermittently during selected functional-task sets at 60% limb occlusion pressure. Outcomes were assessed at baseline and post-intervention, including activities of daily living (Schwab & England ADL scale; self-reported Barthel Index), dynamic balance (Mini-BESTest), mobility (Timed Up and Go), walking endurance (6-minute walk test), and gait spatiotemporal parameters and variability (coefficient of variation). Intervention effects were estimated using linear mixed-effects models with covariate and baseline adjustment. Results. Compared with control at week 8, BFR+Func demonstrated greater improvements in ADL and function: Schwab & England (+6.91 points; 95% CI [2.47, 11.35]), self-reported Barthel Index (+1.68; [0.42, 2.93]), Mini-BESTest (+4.00; [1.27, 6.74]), Timed Up and Go (−3.23 s; [−4.96, −1.50]), and 6-minute walk distance (+69.71 m; [29.26, 110.17]). BFR+Func also improved gait performance and stability versus control, including gait speed (+0.23 m/s; [0.12, 0.34]), step length (+0.08 m; [0.03, 0.13]), step time (−0.06 s; [−0.08, −0.03]), gait speed variability (−3.45%; [−5.10, −1.79]), and step length variability (−2.33%; [−4.38, −0.28]). Func showed smaller benefits versus control for Schwab & England (+5.05; [0.50, 9.60]) and selected gait outcomes (e.g., gait speed +0.13 m/s; [0.01, 0.24]). Mild adverse events were reported in 0/11 (control), 2/11 (Func), and 3/11 (BFR+Func), mainly transient soreness or fatigue; no serious events occurred. Conclusions. In this pilot three-arm trial, both functional training programs improved daily function compared with health education, while adding BFR to task-oriented functional training yielded larger gains in balance, mobility, walking endurance, and gait stability with acceptable tolerability. Larger, adequately powered trials with longer follow-up are warranted to confirm efficacy and durability.