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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03921840
• Other study ID #: IRB00205661
• Secondary ID: P30NR018093
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: September 10, 2020

Study information

• Verified date: October 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 10, 2020
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Pain
• Pain
• Sleep

Intervention

Behavioral:
• ELDERFITNESS
In person training: Participants will receive a 2-hour in person education session with the exercise trainer. Self-monitoring: Subjects will self-monitor subjects' level of physical activity (steps & minutes of moderate activity) using the smartwatch. The Google calendar and Fitbit apps will send messages and alerts to the subject's smartwatch that encourage subjects to achieve subjects' daily goals. If a participant has low activity for 3 consecutive days, the research assistant will call the participant to either encourage the participant to adhere to the plan or provide a modified plan after consulting the exercise trainer. Phone consultation: Subjects will have biweekly phone consultation with the research team members to receive guidance and adjustment on activity plans. Financial incentives: The intervention will include financial incentives. Specifically, when the daily activity goal is achieved for more than four days per week, a $5 reward will be given to subjects.

Other:
• Control
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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Objective Sleep Duration	Total sleep time (minutes) will be measured using actigraph	Week 1, Week 14
Primary	Change in Sleep Efficiency as Assessed by Actigraphy	Sleep efficiency (reported as a percentage)will be measured using actigraph	Week 1, Week 14