A Personalized Behavioral Intervention to Improve Physical Activity, Sleep and Cognition in Sedentary Older Adults

Cognitive decline and sleep complaints are prevalent in older adults and severely affect older adults' physical health and quality of life. Sedentary lifestyle, which is reported by 90% of older Americans, is an important risk factor for both cognitive decline and sleep disturbances. Although promoting physical activity has benefits to older adults' health, including sleep and cognition, traditional interventions to increase activity are challenging due to extensive staffing requirements and low adherence. Electronic activity monitors, such as wrist-worn accelerometers, can track heart rate, activity, and sleep to allow individuals to work towards personal activity and sleep goals. These appealing features make these devices ideal for interventions that aim to change behaviors and improve health outcomes. However, the efficacy of using electronic activity monitors to promote physical activity and health in older adults has not been examined.

The investigators will conduct a randomized controlled trial in a cohort of older adults (without dementia) with both sedentary lifestyle and nocturnal sleep complaints to examine the effectiveness of a personalized behavioral intervention (compared to a control group) embedded within a smart watch application in older adults. 94 cognitively intact elders and 21 older adults with mild cognitive impairment will be enrolled and randomly allocated to the intervention or control group. Participants in the intervention arm will receive in person exercise training sessions, and personalized, self-monitor physical activity, receive interactive prompts, biweekly phone consultation with the research team, and financial incentives for achieving weekly physical activity goals. The control group will receive general education on physical activity in older adults and continue the routine daily activity during the intervention period. The intervention for older adults without cognitive impairment is 24 weeks and for older adults with mild cognitive impairment is 16 weeks.

Study Overview

• Status: Recruiting
• Conditions: Sleep
• Intervention / Treatment: Behavioral: ELDERFITNESS; Other: Control

• Study Type: Interventional
• Enrollment (Anticipated): 115
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Junxin Li, PhD; Phone Number: 410-502-2608; Email: Junxin.li@jhu.edu
• Study Contact Backup: Name: Lena Sciarratta, BS; Phone Number: 410-929-5259; Email: lsciarr1@jhu.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Johns Hopkins University
      • Contact: Junxin Li, PhD; Phone Number: 410-502-2608; Email: Junxin.li@jhu.edu
      • Contact: Lena Sciarratta, BS; Phone Number: 410-929-5259; Email: lsciarr1@jhu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Intact cognition or mild cognitive impairment
• Poor sleep quality
• Approval from healthcare provider to engage in mild to moderate physical activity
• More than 5 hours of self-reported sedentary time per day
• Understands English

Exclusion Criteria:

• Untreated sleep apnea as diagnosed by polysomnography

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; In-person training with the exercise trainer ( 3 sessions for participants without cognitive impairments over 24 weeks & 4 sessions for older adults with mild cognitive impairment over 16 weeks). Self-monitoring level of physical activity (steps & minutes of moderate activity) using the smart watch. . The Google calendar and Fitbit apps will send messages and alerts to the subject's smart watch 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: when the daily activity goal is achieved for more than four days per week, a $5 reward will be given to subjects.
Placebo Comparator: Control; The control group will receive general education on physical activity for older adults and continue daily activity and healthcare routine. Participants in this group will also receive a Go4Life program book from the National Institute on Aging.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Objective Sleep Duration	Total Sleep time (minutes) will be measured using actigraph	Week 1, Week 26 intact cognition or Week 18 for mild cognitive impairment (MCI)
Change in Sleep Efficiency as Assessed by Actigraphy	Sleep efficiency (reported as a percentage) will be measured using actigraphy	Week 1, Week 26 intact cognition or Week 18 for MCI
Change in Subjective Sleep Quality as Assessed by the Pittsburgh Sleep Quality Index (PSQI)	The PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.	Week 1, Week 26 intact cognition or Week 18 for MCI
Change in Plasma tumor necrosis factor-α (TNF-α)	The TNF (pg/mL) will be measured using Plasma from blood draw	Week 1, Week 26 intact cognition or Week 18 for MCI
Change in Plasma C-reactive protein (CRP)	The CRP (pg/mL) will be measured using Plasma from blood draw	Week 1, Week 26 intact cognition or Week 18 for MCI
Change in Plasma interleukin-6 (IL-6)	The IL-6 (pg/mL) will be measured using Plasma from blood draw	Week 1, Week 26 intact cognition or Week 18 for MCI
Change in Plasma interleukin-1ß (IL-1ß)	The IL-1ß (pg/mL) will be measured using Plasma from blood draw	Week 1, Week 26 intact cognition or Week 18 for MCI
Change in Global Cognition As Assessed by The Cogstate Brief Battery (CBB)	The Cogstate Brief Battery (CBB) will be used as the primary assessment of cognitive function. The CBB is a computer based cognitive battery that scores four core cognitive domains: processing speed, attention/vigilance, visual learning memory and visual working memory. The composite cognition score is the primary cognition measure used to measure global cognitive function. The score will range from 0-400, with a higher score indicating higher performance.	Week 1, Week 26 intact cognition or Week 18 for MCI
Change in Physical Activity (PA) as Assessed by Actigraphy	The Actigraphy (counts/min) will be used as a standardized research tool for PA assessment. Higher counts/min indicate higher level of physical activity.	Week 1, Week 26 intact cognition or Week 18 for MCI
Change in Physical Activity (PA) as assessed by the Physical Activity Scale for the Elderly	Subjective PA will be obtained from the Physical Activity Scale for the Elderly. Score ranges from 0-400. The higher the score the higher the physical activity level.	Week 1, Week 26 intact cognition or Week 18 for MCI

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: JUNXIN LI, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2019
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: older adults; cognition; exercise intervention
• Other Study ID Numbers: IRB00198497; R00NR016484 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No