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. 2023 Jan 3;2023(1):CD011881. doi: 10.1002/14651858.CD011881.pub2

Alessi 1999.

Study characteristics
Methods Study design: RCT
Follow‐up: week 14
Participants Country: USA, Los Angeles
Setting: 1 long‐term care facility
Inclusion criteria:
  • urinary incontinence

  • sleep problems

  • dementia


Exclusion criteria:
  • coma

  • expected length of stay or life expectancy < 3 months

  • severe physical aggression


Number of participants completing the study: 29 (IG 15, CG 14)
Baseline characteristics:
  • age (years, mean): IG 88.6 (SD 10.4); CG 88.3 (SD 5.7)

  • gender (female): IG 87%, CG 93%

  • MMSE score (mean): IG 13.6 (SD 8.5); CG 13.1 (SD 8.1)

  • CIRS‐G Score (mean): IG 13.1 (SD 5.2); CG 14.3 (SD 4.6)


Group differences:
  • no differences between groups for demographic data

  • differences for sleep parameters

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
Outcomes
  • Percentage of night‐time sleep (actigraphy)

  • Maximum duration of sleep episodes, minutes (actigraphy)

  • Mean duration of sleep episodes, minutes (actigraphy)

  • Daytime sleep, percentage (observation)

Funding Sponsorship source:
  • UCLA Claude Pepper Older Americans Independence Center

  • Scpulveda VA Geriatric Research, Education and Clinical Center

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.