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

Not Applicable

Completed

• Conditions: Sleep; Pain
• Interventions: Behavioral: ELDERFITNESS; Other: Control

• Registration Number: NCT03921840
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-19
• Study Start: 2019-07-01
• Primary Completion: 2020-09-10
• Study Completion: 2020-09-10
• Results First Submitted: 2022-07-19
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-07
• Last Update Submitted: 2022-10-07
• Results First Posted: 2022-11-04
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	ELDERFITNESS	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.
Control	Control	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.

Primary Outcome Measures

Name	Time	Method
Change in Objective Sleep Duration	Week 1, Week 14	Total sleep time (minutes) will be measured using actigraph
Change in Sleep Efficiency as Assessed by Actigraphy	Week 1, Week 14	Sleep efficiency (reported as a percentage)will be measured using actigraph

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States