Kemoun 2010.
| Methods | 19‐week RCT | |
| Participants | Country: France Centre: nursing home Diagnosis: mild to severe AD Participants: 38 at baseline, and 31 completed (23 women and 8 men) Experimental Group: n = 20, mean age (SD) = 82.0 years (5.8), mean MMSE (SD) = 12.6 (range = 7‐20) Control Group: n = 18, mean age (SD) = 81.7 years (5.1), mean MMSE = 12.9 Information about education level of participants not provided Inclusion criteria: diagnosis of Alzheimer dementia using DSM‐IV criteria, MMSE < 23, able to walk 10 m without technical assistance Exclusion criteria: none stated |
|
| Interventions | Experimental Group: the exercise program included three different sessions each week, i.e. 1) walking, 2) stamina exercise and 3) a combination of walking, stamina, and balance exercises. For the first 2 weeks of the program participants prepared for the routine program with specific muscles and joint exercises Type of physical exercise: aerobic, balance Frequency: 3 times a week, duration = 1 hour Time period: 15 weeks Control Group: usual care |
|
| Outcomes | Cognition outcome: Rapid Evaluation of Cognitive Functions test (ERFC, French Version) | |
| Notes | Adherence of participants in the intervention was 90% | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomization process not described. Email correspondence, Kemoun, 13 May 2012, description was as follows "The process of randomization was conducted by the randomization manager of the clinical investigation centre of the university hospital of Poitiers. Each randomization number was given for each patient after he had been included in the study by the principal investigator." |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Subjects were randomized into two groups using a permutation table". Methods used to conceal allocation not described |
| 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 | Outcome assessor blinded |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Attrition rate was 18.4%: 4 participants lost from Experimental Group and 3 from Control Group. Reasons for attrition provided |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Other bias | Low risk | None apparent |