Randomized Trial of Combined Aerobic, Resistance, and Cognitive Training to Improve Recovery From Stroke: Feasibility and Safety

Abstract

Background Physical exercise and cognitive training have been recommended to improve cognitive outcomes poststroke, but a multifaceted strategy including aerobic, resistance, and cognitive training to facilitate poststroke recovery has not been investigated. We aimed to assess the feasibility, adherence, and safety of a combined aerobic, resistance, and cognitive training intervention ( CARET + CTI ) after stroke. Methods and Results We prospectively randomized patients presenting with recent stroke to a comparison of a supervised 12‐week CARET + CTI program and a control group receiving sham CARET + CTI . Participants were scheduled for 3 weekly CARET and CTI sessions. All participants underwent pre‐ and postintervention assessments of strength, endurance, and cognition. The primary outcomes were feasibility and adherence, defined as the ratio of scheduled and observed visits, and safety. We enrolled 131 participants, of whom 37 withdrew from the study. There were 17 (20%) withdrawals in the CARET + CTI and 20 (44%) in the control group. The observed‐over‐expected visit ratio was significantly higher in the intervention than in the control group (0.74±0.30 versus 0.54±0.38; P =0.003). A total of 99 adverse events were reported by 59 participants, none of which were serious and related to the intervention. Greater gains in physical, cognitive, and mood outcomes were found in the CARET + CTI group than in the control group, but were not statistically significant after adjustments. Conclusions A CARET + CTI intervention, after stroke, is safe, feasible, and has satisfactory participant adherence over 12 weeks. REGISTRATION URL : https://www.clini​caltr​ials.gov . Unique identifier: NCT 02272426.

Effects of Combined Interventions with Aerobic Physical Exercise and Cognitive Training on Cognitive Function in Stroke Patients: A Systematic Review

“…As indicated in Table 3 , the five randomized controlled trials were rated as having low risk of bias in most domains. In one case [ 33 ], the study was mainly aimed at detecting adherence to the intervention and was categorized as such in the Rob2 template. This study threw up some concerns with regard to the baseline characteristics (differences in the proportion of males and females; incidence of diabetes mellitus between the two groups), the fact that the assessment of the outcome variables was not blinded, and the significantly lower level of adherence in the control group compared to the combined intervention group.…”

“…The final sample sizes of the selected randomized controlled trials ranged from 30 to 179 individuals, with group sizes ranging from 12 to 83 participants. The sample sizes were based on power analyses in four studies [ 32 , 33 , 35 , 36 ], while the other work [ 34 ] indicated that the study was underpowered to detect clinical differences.…”

“…The mean age of the participants ranged from 50.63 to 64.59 years. The mean time elapsed since injury was less than 6 months in [ 32 ], less than 1 year in [ 33 ], and six months or more in the other studies [ 34 , 35 , 36 ].…”

“…The proportion of ischemic/hemorrhagic patients was only specified in three studies [ 33 , 34 , 35 ], but none of them examined whether the type of stroke had an influence on the cognitive outcome.…”

“…Three studies [ 32 , 35 , 36 ] did not report the appearance of adverse events associated with aerobic PE. One study [ 33 ] reported adverse events, but these were all minor. Another study [ 34 ] reported the occurrence of training discontinuation in five participants, but this was due to comorbidities unrelated to aerobic PE.…”