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
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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
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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
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Outcomes |
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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
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Notes |
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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 |