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

Richards 2011.

Study characteristics
Methods Study design: RCT
Follow‐up: week 8
Participants Country: USA
Setting: 10 long‐term care facilities and 3 assisted living facilities
Inclusion criteria:
  • aged ≥ 55 years

  • MMSE score 4–29

  • < 7 hours of total nocturnal sleep time and ≥ 30 minutes of daytime sleep for 5 days and nights)

  • ≥ 2 weeks residency

  • ability to stand with little or no assistance

  • stable doses of all medications and no planned changes during the next 7 weeks


Exclusion criteria:
  • documented near‐terminal medical disorder (including advanced heart, lung, kidney, or liver failure resistant to medical management)

  • unresolved malignancy except for non‐metastatic skin cancer

  • treatment with chemotherapy or pharmacological dose of steroids

  • unstable cardiovascular disease


Baseline characteristics:
  • age (years, mean): IG1 81.8 (SD 7.7), IG2 81.5 (SD 9.2), IG3 81.9 (SD 8.3), CG 82.3 (SD 7.1)

  • gender (female, number): IG1 35 (62.5%), IG2 34 (68.0%), IG3 17 (41.5%), CG 30 (63.8%)

  • MMSE (mean): IG1 19.8 (SD 7.6), IG2 20.3 (SD 7.9), IG3 21.3 (SD 6.1), CG 20.2 (SD 7.7)


Number of participants completing the study: 193 (IG1 55, IG2 50, IG3 41, CG 47)
Group differences: no differences
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.
Outcomes
  • Night‐time total sleep, minutes (polysomnography)

  • Sleep onset latency, minutes (polysomnography)

  • Sleep efficiency (polysomnography)

  • Non‐rapid/rapid eye movement sleep (polysomnography)

Funding Sponsorship source:
  • National Institute of Nursing Research

  • Health Services Research and Development

  • Department of Veterans Affairs

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.