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Clinical Trials/NCT03921840
NCT03921840
Completed
Not Applicable

A Personalized Behavioral Intervention for Older Adults With Musculoskeletal Pain and Sleep Complaints

Johns Hopkins University1 site in 1 country27 target enrollmentJuly 1, 2019
ConditionsSleepPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep
Sponsor
Johns Hopkins University
Enrollment
27
Locations
1
Primary Endpoint
Change in Objective Sleep Duration
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
July 1, 2019
End Date
September 10, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change in Objective Sleep Duration

Time Frame: Week 1, Week 14

Total sleep time (minutes) will be measured using actigraph

Change in Sleep Efficiency as Assessed by Actigraphy

Time Frame: Week 1, Week 14

Sleep efficiency (reported as a percentage)will be measured using actigraph

Study Sites (1)

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