N/A
Completed N=24
A Personalized Behavioral Intervention for Older Adults With Musculoskeletal Pain and Sleep Complaints
Sleep · Postoperative Pain
Source: ClinicalTrials.gov NCT03921840 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Change in Objective Sleep Duration — 19; 2.5 MINUTE
Summary
It is well recognized that physical activity/exercise is an effective intervention to improve sleep, reduce pain and improve function in a variety of pain conditions. Traditional interventions to increase physical activity are challenging in older adults due to extensive staffing requirements and low adherence. The investigators plan to conduct a pilot trial in a cohort of older adults (without dementia) with both chronic musculoskeletal pain and nocturnal sleep complaints to test the effectiveness of a 12-week personalized behavioral intervention (compared to a control group) embedded within a smartwatch application in older adults. 27 cognitively intact elders were enrolled and randomly allocated to intervention or control group. Participants in the intervention arm received a 2-hour in person education session, and personalized, circadian-based activity guidelines, with real time physical activity self-monitoring, interactive prompts, biweekly phone consultation with the research team, and financial incentives for achieving weekly physical activity goal. The control group received general education on physical activity in older adults and continue routine daily activity for 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Objective Sleep Duration |
19; 2.5 | — |
| PRIMARY Change in Sleep Efficiency as Assessed by Actigraphy |
5.1; -0.8 | — |
Eligibility Criteria
Inclusion Criteria
- Intact cognition
- Poor sleep quality
- Self-reported presence of pain
- Capacity for mild to moderate physical activity.
Exclusion Criteria
- Non-ambulatory or have severely impaired mobility,
- Visual or hearing impairment that interfered with assessments, and
- An acute or a terminal illness
- Neuropathic pain
Data sourced from ClinicalTrials.gov (NCT03921840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.