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. 2023 Jan 31;2023(1):CD005562. doi: 10.1002/14651858.CD005562.pub3

Maci 2012.

Study characteristics
Methods RCT
Participants N = 14 (8F/6M)
Alzheimer's Disease, according to National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer’s Disease and Related Disorders Association (NINCDS‐ADRDA) criteria
All receiving a stable dose regimen of memantine and/or cholinesterase inhibitors and/or antidepressants
for at least 6 months prior to the beginning of the study
Mean MMSE 17.8 (SD 2.8)
Age 72.6 (SD 9.5)
Community (gymnasium)
Interventions Cognitive stimulation/physical activity groups (N = 7)
Treatment‐as‐usual (N = 7)
Outcomes Cognition: MMSE; Frontal Assessment Battery
Clinical Dementia Rating
ADL: Katz ADL scale; Lawton & Brody Instrumental Activities of Daily Living scale
Mood: Cornell Scale for Depression in Dementia; Hamilton Anxiety Rating Scale
Quality of Life: Cornell‐Brown Scale for Quality of life in Dementia; Apathy Evaluation Scale; Quality of Life–Alzheimer’s Disease (QoL‐AD; self‐report and caregiver proxy)
Family caregiver outcomes: Caregiver Burden Inventory; Beck Depression Inventory
Notes 120 minutes, five times a week for 3 months
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Randomly assigned to the active treatment group or to the usual care as control group according to a list of randomly generated sequence of numbers."
Allocation concealment (selection bias) Unclear risk No indication of who carried out randomisation or their independence
Blinding of outcome assessment (detection bias)
All outcomes Low risk Examiners blinded
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No mention of attrition ‐ none reported over 3‐month period?
Selective reporting (reporting bias) Low risk All outcomes appear to be reported.
Other bias ‐ training and supervision Low risk Training and supervision provided
Other bias ‐ treatment manual Low risk There was a clear structure, though no indication of a manual as such.