Conradsson 2010.
| Methods | 6‐month cluster‐RCT | |
| Participants | Country: Sweden Multicentre: 9 residential facilities Diagnosis: 100 of a total of 191 participants diagnosed with mild to moderate dementia (type of dementia unspecified) Participants: 191 (139 women and 52 men), mean age (SD) = 84.7 years (6.5), mean MMSE (SD) = 17.8 (5.1) Baseline age, education, and MMSE, not reported for dementia subgroup (n = 100) Of the 100 participants with dementia, 91 completed Experimental Group: n = 47; Control Group: n = 53 Inclusion criteria: 65 years or older, MMSE score ≥ 10, dependent for assistance with at least 1 ADL as per Katz index, able to stand from arm chair with help from no more than 1 person, resident physician approval Exclusion criteria: none stated |
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| Interventions | Experimental Group: the high‐intensity group exercise (3‐9 participants per exercise group) focused on weight bearing and progressively increased in difficulty. Activity consisted of strength and balance exercises including walking, squats and trunk exercises Type of physical activity: strength, balance, aerobic Frequency: 5 sessions every 2 weeks, exercise duration = 45 minutes Time period: 13 weeks Control Group: social contact plus seated activities provided by occupational therapists, e.g. watching films, singing, reading, conversation Frequency: 5 sessions every 2 weeks, activity duration = 45 minutes Time period: 13 weeks |
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| Outcomes | Depression outcome (Conradsson 2010): Geriatric Depression Scale 15‐item Psychological well‐being outcome (Conradsson 2010): Philadelphia Geriatric Centre Morale Scale Activity of Daily Living outcome (Littbrand 2009): Barthel ADL Index |
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| Notes | Note: Conradsson 2010 and Littbrand 2009 articles report on the same trial. Conradsson 2010 reports on depression and Littbrand 2009 reports on ADL We used only data specific to people with dementia in the analysis. Adherence of participants in the intervention was 72%. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Process of random selection not described |
| Allocation concealment (selection bias) | Low risk | Quote: "Researchers not involved in this study performed the randomization using lots in sealed non‐transparent envelopes" (Conradsson 2010) |
| 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: "The assessors of the outcome measures were blinded to group allocation and previous test results" (Conradsson 2010) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The attrition rate for the Experimental Group was 14.3%, and that of the Control Group 9.0%. Trial authors specified reasons for attrition in each group. ITT principles used in analyses. However, only 91 of the original 100 participants were included in the ITT analysis |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Other bias | Low risk | None apparent |