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

Johns Hopkins University logo

Johns Hopkins University

Status

Completed

Conditions

Pain
Sleep

Treatments

Other: Control
Behavioral: ELDERFITNESS

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03921840
P30NR018093 (U.S. NIH Grant/Contract)
IRB00205661

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

60 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

27 participants in 2 patient groups, including a placebo group

Intervention
Experimental group
Description:
Based on the self-efficacy theory, participants in the intervention arm will receive personalized, circadian-based activity guidelines, a 2-hour in person education session, real time physical activity self-monitoring, interactive prompts, biweekly phone consultation with the research team, and financial incentives for achieving weekly physical activity goal.
Treatment:
Behavioral: ELDERFITNESS
Control
Placebo Comparator group
Description:
The control group will receive general education on physical activity for older adults and continue daily activity and healthcare routine. Participants will also receive a Go4Life program book from the National Institute on Aging.
Treatment:
Other: Control

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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