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

NCT03959202 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2023-03-08

No results posted yet for this study

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

Interventions

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.

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

Sponsors & Collaborators

Principal Investigators

  • Junxin Li, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-11
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03959202 on ClinicalTrials.gov