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

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ClinicalTrials.gov Identifier: NCT03959202
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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 24-week personalized behavioral intervention (compared to a control group) embedded within a smartwatch application in older adults. 94 cognitively intact elders will be enrolled and randomly allocated to intervention or control group. Participants in the intervention arm will receive 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 will receive general education on physical activity in older adults and continue routine daily activity for 24 weeks. The global hypothesis is that the proposed intervention will result in increased physical activity, longer nocturnal sleep duration, and improved cognitive performance over the course of 24 weeks. In addition, plasma inflammatory biomarkers will be assessed to explore mechanisms for associations among the study outcomes.


Condition or disease Intervention/treatment Phase
Sleep Behavioral: ELDERFITNESS Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Personalized Behavioral Intervention to Improve Physical Activity, Sleep and Cognition in Sedentary Older Adults
Actual Study Start Date : July 11, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


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: 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.

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




Primary Outcome Measures :
  1. Change in Objective Sleep Duration [ Time Frame: Week 1, Week 26 ]
    Total Sleep time (minutes) will be measured using actigraph

  2. Change in Sleep Efficiency as Assessed by Actigraphy [ Time Frame: Week 1, Week 26 ]
    Sleep efficiency (reported as a percentage) will be measured using actigraphy

  3. Change in Subjective Sleep Quality as Assessed by the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Week 1, Week 26 ]
    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.

  4. Change in Plasma tumor necrosis factor-α (TNF-α) [ Time Frame: Week 1, Week 26 ]
    The TNF (pg/mL) will be measured using Plasma from blood draw

  5. Change in Plasma C-reactive protein (CRP) [ Time Frame: Week 1, Week 26 ]
    The CRP (pg/mL) will be measured using Plasma from blood draw

  6. Change in Plasma interleukin-6 (IL-6) [ Time Frame: Week 1, Week 26 ]
    The IL-6 (pg/mL) will be measured using Plasma from blood draw

  7. Change in Plasma interleukin-1ß (IL-1ß) [ Time Frame: Week 1, Week 26 ]
    The IL-1ß (pg/mL) will be measured using Plasma from blood draw

  8. Change in Global Cognition As Assessed by The Cogstate Brief Battery (CBB) [ Time Frame: Week 1, Week 26 ]
    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.

  9. Change in Physical Activity (PA) as Assessed by Actigraphy [ Time Frame: Week 1, Week 26 ]
    The Actigraphy (counts/min) will be used as a standardized research tool for PA assessment. Higher counts/min indicate higher level of physical activity.

  10. Change in Physical Activity (PA) as assessed by the Physical Activity Scale for the Elderly [ Time Frame: Week 1, Week 26 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Intact cognition
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959202


Contacts
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Contact: Junxin Li, PhD 410-502-2608 Junxin.li@jhu.edu
Contact: Lena Sciarratta, BS 410-929-5259 Lsciarr1@jhu.edu

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Junxin Li, PhD    410-502-2608    Junxin.li@jhu.edu   
Contact: Lena Sciarratta, BS    410-929-5259    lsciarr1@jhu.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Junxin Li, PhD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03959202     History of Changes
Other Study ID Numbers: IRB00198497
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
older adults
exercise intervention
cognition