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

NCT03959202 | Completed Phase 1

• 2 other identifiers: IRB00198497R00NR016484
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep

Keywords

older adults; exercise intervention; cognition

Outcome Measures

Primary Outcomes (10)

• 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

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 in this group will also receive a Go4Life program book from the National Institute on Aging.

Other: Control

Interventions

ELDERFITNESS BEHAVIORAL

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.

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 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

You may not qualify if:

• Untreated sleep apnea as diagnosed by polysomnography

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

Study Officials

• Junxin Li, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 22, 2019
• Study Start: July 11, 2019
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 8, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)