Richards 2011.
Study characteristics | ||
Methods |
Study design: RCT Follow‐up: week 8 |
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Participants |
Country: USA Setting: 10 long‐term care facilities and 3 assisted living facilities Inclusion criteria:
Exclusion criteria:
Baseline characteristics:
Number of participants completing the study: 193 (IG1 55, IG2 50, IG3 41, CG 47) Group differences: no differences |
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Interventions |
Intervention 1: exercise. Consisted of high‐intensity physical resistance strength training and walking programme. Hypothesised that the combination of both activities would have positive effects on total physical activity. Strength training consisted of hip extensions on a hip‐extension/leg‐press chair plus arm extensions from a seated position in a chest‐press chair. Exercises supervised by trained nurses. High‐intensity physical resistance strength training performed 3 days a week and on 2 further days, participants walked for up to 45 minutes. Intervention 2: social activity. Consisted of individualised social activities for 1 hour a day, 5 days a week. Nursing assistants in the research project performed social activities. They received 40 hours of training to be able to plan and guide activities for residents. Intervention 3: exercise plus social activity Control: usual care Interventions duration 7 weeks. |
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Outcomes |
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Funding |
Sponsorship source:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Sequence generation | Low risk | Sealed envelopes with participants' group assignments prepared by a research team member otherwise not involved with the study to enact randomisation. Inside the envelope was the participant's group assignment determined using a random number generator with random block sizes to balance the assignments across the 4 groups. |
Allocation concealment | Low risk | Sealed envelopes with participants' group assignments were prepared by a research team member otherwise not involved with the study to enact randomisation. The project director opened the envelopes after baseline data collection. |
Blinding of participants and personnel All outcomes | Unclear risk | Unknown. |
Blinding of participants and personnel Subjective sleep quality (carer ratings) | Unclear risk | Unknown. |
Blinding of participants and personnel Objective sleep measures | Unclear risk | Unknown. |
Blinding of outcome assessors Objective outcome measures | Low risk | Because of the nature of the intervention and control conditions, only the sleep technicians and registered polysomnography technologist were blinded to group assignment. Participants, investigators, project staff, and residential staff were not blinded. |
Blinding of outcome assessors Subjective sleep quality (carer ratings) | Unclear risk | No information available. |
Incomplete outcome data All outcomes | Low risk | Clearly number of dropouts related to interventions (9 each, while only 1 in CG), but possibly adequate imputation used. Quote: "Using the intention‐to‐treat approach, regression imputation was performed for the missing postintervention variables using a Stata regression algorithm." |
Selective outcome reporting | Low risk | In line with study registration: NCT00888706. |
Other sources of bias | Low risk | None. |