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. |