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. 2019 Mar 13;2019(3):CD012277. doi: 10.1002/14651858.CD012277.pub2

van het Reve 2014.

Methods
  • Design: international multi‐centre 2‐arm RCT with parallel‐group design

  • Recruitment period: 2011 to 2013

  • No. of centres involved: 14

  • Unit of randomisation: individuals

  • No. randomised: 182

  • Number of arms considered in this review: 2

  • Maximum trial duration: 3 months

  • Funding by non‐profit organisation: none reported

  • Funding by commercial organisation: none reported

  • Publication status: full‐text report

Participants
  • Patient flow: 84 randomised, 69 described at baseline in experimental group; 98 randomised, 76 described at baseline in control group

  • Number of females: 49 of 69 (71%) in experimental group 1; 52 of 76 (68%) in control group 1

  • Average age (SD): 81 (8.3) years in experimental group 1; 82 (6.3) years in control group

  • Education: experimental group 1: university/college 7 (10), vocational education 41 (59), no educated profession 21 (30), in a sitting position past profession 18 (26); control 1: university/college 4 (5), vocational education 52 (68), no educated profession 20 (26), in a sitting position past profession 15 (20)

  • Baseline cognitive function: selection criteria on cognition overall: healthy

  • Selection criteria on cognition: experimental group: MMSE score (mean ± SD): 27.6 ± 2.6; control group: MMSE score (mean ± SD): 27.7 ± 2.9

  • Ethnicity: not reported

  • APOE: number of participants positive for APOE not reported*

Interventions Type of experimental intervention: computerised CT group; treatment duration of 12 weeks; intervention provided in group format, under supervision
  • Details of experimental intervention: cognitive training, with the CogniPlus training programme

  • Type of concomitant treatment provided: strength‐balance training

  • Session duration: 10 minutes in experimental group

  • Number of treatment sessions: 36 in experimental group

  • Treatment frequency: 3/week in experimental group

  • Maximum treatment duration in weeks: 12 in experimental group


Type of control intervention: other; treatment duration of 12 weeks; intervention provided in group format, under supervision
  • Details of control intervention: exercise programme consisted of twice‐weekly 30‐minute progressive resistance training on age‐adapted machines and 10‐minute balance training during 12 weeks

  • Type of concomitant treatment provided: strength‐balance training

  • Session duration: 40 minutes in control group

  • Number of treatment sessions: 24 in control group

  • Treatment frequency: 2/week in control group

  • Maximum treatment duration in weeks: 12 in control group

Outcomes
  • Cognitive functioning outcomes considered

    • Executive functioning measured with TMT‐B at 3 months, on a scale from not reported to not reported with lower values indicating benefit

    • Speed of processing measured with TMT‐A at 3 months, on a scale from not reported to not reported with lower values indicating benefit

  • Physical functioning outcome considered: none reported

  • Quality of life outcome considered: none reported

  • Safety outcome considered: none reported

  • Depression outcome considered: none reported

Notes Due to strength‐balance training, which was given to both groups, we included the study in the inactive control comparison
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Judgement: adequate random sequence generation
Quote(s): "to ensure allocation concealment, participants in each home were enrolled by the health care staff, and randomized by the person assessing the outcome measures using simple (unrestricted) randomisation.. based on a table of random numbers"
Allocation concealment (selection bias) Unclear risk Judgement: unclear allocation concealment
Quote(s): "the assessor generated an unpredictable allocation sequence, which was concealed until assignment occurred. Each participant in every home received a two digit number (01, 02, 03, …) resulting in a rank order of the participants. With the help of the random numbers table the assessor decided a priori to pick a number from the table with a pencil and go through the table either from bottom‐right to upper‐left in a diagonal way, horizontally from left‐to‐right or right‐to‐left, etc"
Blinding of participants (performance bias) Unclear risk Judgement: patient blinding was not reported, but it is unlikely
Quote(s): "blinding of the investigator was not possible because the investigator conducted part of the assessments"
Blinding of personnel (performance bias) High risk Judgement: investigators were not blinded
Quote(s): "blinding of the investigator was not possible because the investigator conducted part of the assessments"
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Judgement: outcome assessment was not blinded
Quote(s): "blinding of the investigator was not possible because the investigator conducted part of the assessments"
Incomplete outcome data (attrition bias) 
 All outcomes High risk Judgement: 69 out of 84 (82%) randomised were analysed in the experimental group, and 76 out of 98 (78%) randomised were analysed in the control group, although statistical analyses were reported to be done according to the intent‐to‐treat principle. In addition, 4 participants were re‐assigned by investigators to the control group despite being initially randomised to the intervention group
Quote(s): "a total of 156 participants completed the intervention (137 subjects living in the homes‐for‐the‐aged and 19 subjects living in the vicinity) resulting in 14.3% attrition"; "Four participants that were not able to conduct the cognitive training due to vision problems were manually allocated to the SB group after randomization. Thus, we reported 98 participants in SB and 84 participants in SBC after this adaptation"
Selective reporting (reporting bias) Low risk Judgement: all outcomes indicated in the methods section are reported in the results section
Other bias Low risk Judgement: no other sources of bias detected
Quote(s): none

AC: active control.

AE: adverse event.

APOE: apolipoprotein E.

AR: aerobics and resistance.

BDT‐DT: The Baddeley Dual Task

CCI: computerised cognitive intervention.

COWAT: Controlled Oral Word Association Test.

CT: computed tomography.

CWIT: Color‐Word Interference Test.

DT: dual task.

FCSRT: Free and Cued Selective Reminding Test.

GDS‐Sf: short‐form Geriatric Depression Scale.

HVLT: Hopkins Verbal Learning Test.

ITT: intention‐to‐treat.

MMRM: mixed model for repeated measures.

MMSE: Mini Mental State Examination.

MoCA: Montreal Cognitive Assessment.

RBMT: Rivermead Behavioural Memory Test.

RCT: randomised controlled trial.

RT: Reaction time.

SAE: serious adverse event.

SD: standard deviation.

ST: stretching and toning.

SVP: speed of visual information processing.

TMT: Trail Making Test.

WMS‐III: Wechsler Memory Scale, Third Edition.