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

NCT03921840 | Completed Results DMC

• 2 other identifiers: IRB00205661P30NR018093
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Pain

Outcome Measures

Primary Outcomes (2)

• Change in Objective Sleep Duration

  Total sleep time (minutes) will be measured using actigraph

  Week 1, Week 14

• Change in Sleep Efficiency as Assessed by Actigraphy

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

  Week 1, Week 14

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: ELDERFITNESS

Control

PLACEBO COMPARATOR

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.

Other: Control

Interventions

ELDERFITNESS BEHAVIORAL

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.

Intervention

Control OTHER

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.

Control

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intact cognition
• Poor sleep quality
• Self-reported presence of pain
• Capacity for mild to moderate physical activity.

You may not qualify if:

• Non-ambulatory or have severely impaired mobility,
• Visual or hearing impairment that interfered with assessments, and
• An acute or a terminal illness
• Neuropathic pain

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Junxin Li
• Organization: Johns Hopkins University

jli248@jhu.edu

4105022608

Study Officials

• Junxin Li, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 19, 2019
• Study Start: July 1, 2019
• Primary Completion: September 10, 2020
• Study Completion: September 10, 2020
• Last Updated: November 4, 2022
• Results First Posted: November 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)