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

Shatil 2013.

Methods
  • Design: 4‐arm RCT with parallel‐group design

  • Recruitment period: not reported

  • No. of centres involved: 1

  • Unit of randomisation: individuals

  • No. randomised: 180

  • Number of arms considered in this review: 4

  • Maximum trial duration: 4 months

  • Funding by non‐profit organisation: Beckman Insititute

  • Funding by commercial organisation: none reported

  • Publication status: full‐text report

Participants
  • Patient flow: 45 randomised, 33 described at baseline in experimental group 1; 48 randomised, 29 described at baseline in experimental group 2; 45 randomised, 31 described at baseline in experimental group 3; 42 randomised, 29 described at baseline in control group

  • Number of females: 23 of 33 (70%) in experimental group 1; 20 of 29 (69%) in experimental group 2; 22 of 31 (71%) in experimental group 3; 19 of 29 (66%) in control group 1

  • Average age (SD): 80 (5.4) years in experimental group 1; 79 (5.5) years in experimental group 2;79 (5.8) years in experimental group 3; 81 (5.3) years in control group 1

  • Average (SD) education: experimental group 1: some college and above: 26 (78,8%); experimental group 2: some college and above: 17 (58,6%); experimental group 3: some college and above: 28 (90,3%); control group 1: some college and above: 23 (79,3%)

  • Baseline cognitive function: MMSE > 24

  • Selection criteria on cognition overall: healthy

  • Ethnicity: not reported

  • APOE: number of participants positive for APOE not reported

Interventions Type of experimental intervention 1: computerised CT group; treatment duration of 16 weeks; intervention provided in group format, under supervision
  • Details of experimental intervention: Cognifit

  • Session duration: 40 minutes in experimental group

  • Number of treatment sessions: 48 in experimental group

  • Treatment frequency: 3/week in experimental group

  • Maximum treatment duration in weeks: 16 in experimental group


Type of experimental intervention 2: mixed
  • Details of experimental intervention 2: cognitive training as for experimental arm 1 in combination with group‐based supervised physical training, which consisted of 3 weekly 45‐minute sessions, with at least a 1‐day interval between training days, during 16 weeks

  • Session duration: 40 minutes in experimental group 2

  • Number of treatment sessions: 48 in experimental group 2

  • Treatment frequency: 3/week in experimental group 2

  • Maximum treatment duration in weeks: 16 in experimental group 2


Type of control intervention 1: other; treatment duration of 16 weeks; intervention provided in group format, under supervision
  • Details of control intervention: this group was assigned selected book excerpts to be read at home and held one 60‐minute weekly meeting during which the best ways to achieve the goals advocated in the book were discussed. This group was classified as an active control group because it was compared with the Cognifit group

  • Session duration: 60 minutes in control group

  • Number of treatment sessions: 16 in control group

  • Treatment frequency: 1/week in control group

  • Maximum treatment duration: 16 in control group


Type of control intervention 2: other; intervention provided in group format, under supervision
  • Details of control intervention 2: group‐based supervised physical training. This group was classified as an inactive control group because it was compared with the mixed experimental intervention

  • Session duration: 45 minutes in control group 2

  • Number of treatment sessions: 48 in control group 2

  • Treatment frequency: 3/week in control group 2

  • Maximum treatment duration in weeks: 16 in control group 2

Outcomes
  • Cognitive functioning outcomes considered for both comparisons

    • Speed of processing measured with SVP at 4 months, on a scale from not reported to not reported with higher values indicating benefit

    • Working memory measured with AM Cognifit at 4 months, on a scale from not reported to not reported with higher 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

  • Other outcome data on cognitive functioning, not considered in our meta‐analyses

    • Cognitif subtests

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Judgement: method of random sequence generation not reported
Quote(s): "following the screening subjects were randomized to the four intervention groups"
Allocation concealment (selection bias) Unclear risk Judgement: method of allocation concealment not reported
Quote(s): "following the screening subjects were randomized to the four intervention groups"
Blinding of participants (performance bias) Unclear risk Judgement: no information reported
Blinding of personnel (performance bias) Unclear risk Judgement: no information reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Judgement: blinding of outcome assessment not reported
Quote(s): "to measure change in cognitive function following the interventions, we used the CogniFit neuropsychological evaluation"
Incomplete outcome data (attrition bias) 
 All outcomes High risk Judgement: 62 out of 93 (67%) randomised were analysed in experimental group, and 60 out of 87 (69%) randomised were analysed in control group
Quotes: "55 participants (30.5%) left during the baseline testing period, while another battery of tests (to be reported elsewhere) were being administered; before the training interventions.."; "three participants, two in the Cognitive Training Group and one in the Physical Activity Group, left the study, due to health problems. Thus, altogether, 58 subjects (32.2% among the 180 enlisted study participants) withdrew from the study and 122 adhered to it"
Selective reporting (reporting bias) Low risk Judgement: all outcomes indicated in the methods section are reported in the results section
Other bias High risk Judgement: potential high risk of bias because the main author (Shatil) is an employee of the CogniFit Company