Alessi 1999.
Study characteristics | ||
Methods |
Study design: RCT Follow‐up: week 14 |
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Participants |
Country: USA, Los Angeles Setting: 1 long‐term care facility Inclusion criteria:
Exclusion criteria:
Number of participants completing the study: 29 (IG 15, CG 14) Baseline characteristics:
Group differences:
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Interventions |
Intervention: daily physical activity for 14 weeks, noise reduction night‐time programme for the last 5 days the of intervention, education for staff, reminding signs. Intervention consisted of functional incidental training, performed during daily nursing care routines (e.g. toileting). Training included arm and leg exercises, sit‐to‐stands, and walking or wheelchair propulsion, depending on participants' abilities. Trained research staff conducted the training sessions every 2 hours between 8.00 a.m. and 16.00 p.m. (maximum 5 sessions a day). Intervention performed 5 days a week, for 14 weeks in total. After the 14 weeks, the additional night‐time programme was introduced for 5 nights. This aimed to minimise light, noise, and sleep‐disruptive nursing care interventions at night. Control: noise reduction night‐time programme |
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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 | Unclear risk | Of the remaining 29 participants, 15 were randomised to receive the combined daytime physical activity plus night‐time environmental programme (IG), and 14 were randomised to receive the night‐time programme alone (CG). |
Allocation concealment | Unclear risk | Unknown. |
Blinding of participants and personnel All outcomes | Unclear risk | Probably not blinded, but risk of bias unclear. |
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 | Blinded assessment of actigraphy results (night‐time), observers blinded. |
Blinding of outcome assessors Subjective sleep quality (carer ratings) | Unclear risk | No information available. |
Incomplete outcome data All outcomes | Low risk | No information about 4 dropouts. |
Selective outcome reporting | Unclear risk | No protocol identified. |
Other sources of bias | Low risk | None. |