Yeh 2019.
Study characteristics | ||
Methods |
Design: single‐blind, multisite RCT Duration of trial: 1 year (September 2016 to September 2017) Unit of randomisation: people with ≥ 6 months after ischaemic or haemorrhagic stroke with cognitive dysfunction stratified by MMSE scores (Strata 1: MMSE score: 19 to 24; Strata 2: MMSE score: 25–30) undergoing rehabilitation and matched for baseline characteristics Recruitment and allocation: of 46 people recruited from rehabilitation units, 30 were stratified by MMSE score then randomised to 1 of 2 groups: IG (n = 15) and active CG (n = 15) |
|
Participants |
Setting: rehabilitation units Country: Taiwan Sample size: 30 adults, 70% men; IQ: 15 (53% men); CG: 15 (87% men) Inclusion criteria: ischaemic or haemorrhagic stroke occurring ≥ 6 months before enrolment; MMSE score ≥ 19; MoCA score < 26; self‐reported or informant‐reported memory or cognitive complaints or score on the Clinical Dementia Rating scale 0.5; able to follow the study instruction; adequate cardiopulmonary function to perform aerobic exercise; and able to walk with or without assistive devices Exclusion criteria: unstable medical history that might limit participation concomitant with other neurological disorders, such as Parkinson disease, amyotrophic lateral sclerosis, and multiple sclerosis; current participation in another interventional trial Age: mean: IG: 50.63 (SEM 3.99) years; CG: 60.21 (SEM 3.10) years Time since onset of stroke: mean: IG: 47.80 (SEM 11.49) months; CG: 94.43 (SEM 30.80) months Types of stroke: not reported Site of lesion: not reported |
|
Interventions |
Intervention group Brief name: SEQ (sequential) Recipients: adults > 6 months poststroke with cognitive dysfunction Why: to provide a sequential combination of aerobic exercise and CT to "prepare the brain for the compensatory recruitment process in the cognitive training sessions that follow"; CT aimed to enhance cognitive functions, to facilitate several cognitive functions, including attention, recognition, colour and shape identification, calculation, visual perception, visuospatial processing, and executive function. What (materials): stationary bicycle; BrainHQ (Posit Science) computer‐based software and personal computer What (procedures): aerobic exercise followed by CT:
Who provided: not reported in the paper but confirmed by author contact that the intervention was delivered by certified occupational therapists. How: face‐to‐face individually monitored by staff Where: not specified but within rehabilitation unit When and how much: 60 minutes per session consisting of 30 minutes of exercise and 30 minutes of CT, 2 or 3 days per week for 12–18 weeks for a total of 36 sessions (36 hours in total) Tailoring: exercise intensity was progressed as participants improved their performance throughout the training; CT programme was adjusted automatically and continuously according to each participant's level of performance. Modifications: none reported How well (planned): not reported How well (actual): not reported except that the intervention was "feasible and safe, with low dropout rates". Comparator group Brief name: active control Recipients: adults > 6 months poststroke with cognitive dysfunction Why: to provide comparable active activities What: exercise training followed by mental activities:
Who provided: not reported How: face‐to‐face Where: not specified except within rehabilitation unit When and how much: 60 minutes of training sessions, 2 or 3 days per week for 12–18 weeks for a total of 36 sessions (36 hours in total) Tailoring: not reported Modifications: not reported How well (planned): not reported How well (actual): not reported |
|
Outcomes |
Primary: none Secondary
Other
Methods of data collection: evaluator blinded to the group allocation assessed participants before and after the intervention programmes. Data collection time points: within 1 week before and after intervention (12–18 weeks) |
|
Notes |
Funding: yes Conflict of interest: none Published trial protocol: no Trial registration: yes; NCT03045991 Ethics approval: yes Author contact: further information requested and provided |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation scheme was generated with the web‐based Research Randomizer randomisation tool. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of participants or personnel for intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The evaluator for the before and after assessments was blinded to the patient's group allocation" and "… the assessments were conducted by a trained and experienced therapist who was blinded to group allocation". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Flow diagram indicated there were no dropouts. |
Selective reporting (reporting bias) | Low risk | All relevant outcomes from method and protocol reported. |
Other bias | Low risk | No other identifiable bias. |