Steinberg 2009.
Methods | 12‐week randomly‐assigned experimental trial | |
Participants | Country: USA Location: home Diagnosis: mild to moderate AD Participants: 27 at baseline (19 women and 8 men) all of whom completed; information about education level not provided Experimental Group: n = 14; mean age (SD) = 76.5 years (3.9); mean MMSE (SD) = 20.1 (5.1) Control Group: n = 13; mean age (SD) = 74.0 years (8.1); mean MMSE (SD) = 15.5 (5.4) Inclusion criteria: probable AlD using Alzheimer Disease of National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association criteria; MMSE ≥ 10; residing in community; stable health and medical history; caregiver that was spending a minimum of 10 hours per week with the person with AD Exclusion criteria: residing in assisted‐living facility |
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Interventions | Experimental Group: exercise program consisting of aerobic, strength, balance, and flexibility training Type of physical activity: aerobic, strength, balance Frequency: daily, exercise duration not specified. Participants were given points for each activity performed. The weekly exercise goal was obtained when the participant collected 6 aerobic points, and 4 strength and balance points Time period: 12 weeks Control Group: social contact, e.g. received home safety assessment that included 2 home visits. In addition, participants recorded 3 activities they performed regularly at home |
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Outcomes | Cognition outcome: 1‐h cognitive battery that included the Boston Naming Test, MMSE, and Hopkins Verbal Learning Test Depression outcomes
Caregiver Burden outcome: Screen for Caregiver Burden |
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Notes | The necessary data were not reported on attrition, cognition, depression, or caregiver burden, and the authors did not provide them upon request. Adherence of participants was reflected by receipt of 59% of the diaries and 75% of the exercise group met their goals | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Stratified randomization by age and gender. Emailed 13 March 2012, 10 April 2012, and 9 May 2012, to clarify randomization, but no answer received |
Allocation concealment (selection bias) | Unclear risk | No description of methods used to conceal allocation |
Blinding (performance bias and detection bias) All outcomes | High risk | Not possible to blind participants and the personnel to the intervention allocated |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All tests were administered by the same rater, who was masked as to treatment assignment" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition not reported. Requested attrition data 13 March 2012, 10 April 2012, 9 May 2012, and 3 July 2012, but data not provided. Performed ITT analyses using linear random effects models |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | None apparent |