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. 2022 Mar 29;2022(3):CD006430. doi: 10.1002/14651858.CD006430.pub3

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:
  • aerobic exercise training: using a progressive resistance stationary bicycle, 3 minutes of warm‐up, 25 minutes of aerobic resistance exercise ending with 2 minutes of cool down; target heart rate 40–70% maximal heart rate (208 − 0.7 × age); vital signs and perceived effort (Borg Perceived Exertion Scale) monitored and recorded each session

  • computer‐based CT used to facilitate cognitive functions including attention, recognition, colour and shape identification, calculation, visual perception, visuospatial processing, and executive function


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:
  • non‐aerobic exercise training including flexibility exercise, muscle strengthening, and balance training;

  • unstructured mental activities that did not train a specific cognitive domain; participants chose to read newspapers or magazines or watch videos of topics derived from health‐related materials. After the unstructured mental activities, participants were asked several questions about the content that they just received.


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
  • Community Integration Questionnaire

  • MoCA

  • Spatial Span test from Wechsler Memory Scale – Third Edition

  • Verbal Paired Associates subtest Wechsler Memory Scale – Third Edition


Other
  • 6‐minute walk test

  • International Physical Activity Questionnaires

  • EQ‐5D


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.