免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / A Personalized Behavioral Intervention to Improve Physical Activity, Sleep and Cognition in Sedentary Older Adults

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

Study Description
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 smartwatch 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.


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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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
Arms and Interventions
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 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: 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

Outcome Measures
Primary Outcome Measures :
  1. Change in Objective Sleep Duration [ Time Frame: Week 1, Week 26 intact cognition or Week 18 for MCI ]
    Total Sleep time (minutes) will be measured using actigraph

  2. Change in Sleep Efficiency as Assessed by Actigraphy [ Time Frame: Week 1, Week 26 intact cognition or Week 18 for MCI ]
    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 intact cognition or Week 18 for MCI ]
    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 intact cognition or Week 18 for MCI ]
    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 intact cognition or Week 18 for MCI ]
    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 intact cognition or Week 18 for MCI ]
    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 intact cognition or Week 18 for MCI ]
    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 intact cognition or Week 18 for MCI ]
    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 intact cognition or Week 18 for MCI ]
    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 intact cognition or Week 18 for MCI ]
    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.


Eligibility Criteria
Layout table for eligibility information
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 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
Contacts and Locations

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

Locations
Layout table for location information
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
National Institute of Nursing Research (NINR)
Investigators
Layout table for investigator information
Principal Investigator: Junxin Li, PhD Johns Hopkins University
Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date March 18, 2021
Actual Study Start Date  ICMJE July 11, 2019
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2021)
  • Change in Objective Sleep Duration [ Time Frame: Week 1, Week 26 intact cognition or Week 18 for MCI ]
    Total Sleep time (minutes) will be measured using actigraph
  • Change in Sleep Efficiency as Assessed by Actigraphy [ Time Frame: Week 1, Week 26 intact cognition or Week 18 for MCI ]
    Sleep efficiency (reported as a percentage) will be measured using actigraphy
  • Change in Subjective Sleep Quality as Assessed by the Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Week 1, Week 26 intact cognition or Week 18 for MCI ]
    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.
  • Change in Plasma tumor necrosis factor-α (TNF-α) [ Time Frame: Week 1, Week 26 intact cognition or Week 18 for MCI ]
    The TNF (pg/mL) will be measured using Plasma from blood draw
  • Change in Plasma C-reactive protein (CRP) [ Time Frame: Week 1, Week 26 intact cognition or Week 18 for MCI ]
    The CRP (pg/mL) will be measured using Plasma from blood draw
  • Change in Plasma interleukin-6 (IL-6) [ Time Frame: Week 1, Week 26 intact cognition or Week 18 for MCI ]
    The IL-6 (pg/mL) will be measured using Plasma from blood draw
  • Change in Plasma interleukin-1ß (IL-1ß) [ Time Frame: Week 1, Week 26 intact cognition or Week 18 for MCI ]
    The IL-1ß (pg/mL) will be measured using Plasma from blood draw
  • Change in Global Cognition As Assessed by The Cogstate Brief Battery (CBB) [ Time Frame: Week 1, Week 26 intact cognition or Week 18 for MCI ]
    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.
  • Change in Physical Activity (PA) as Assessed by Actigraphy [ Time Frame: Week 1, Week 26 intact cognition or Week 18 for MCI ]
    The Actigraphy (counts/min) will be used as a standardized research tool for PA assessment. Higher counts/min indicate higher level of physical activity.
  • Change in Physical Activity (PA) as assessed by the Physical Activity Scale for the Elderly [ Time Frame: Week 1, Week 26 intact cognition or Week 18 for MCI ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Change in Objective Sleep Duration [ Time Frame: Week 1, Week 26 ]
    Total Sleep time (minutes) will be measured using actigraph
  • 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
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Personalized Behavioral Intervention to Improve Physical Activity, Sleep and Cognition in Sedentary Older Adults
Official Title  ICMJE A Personalized Behavioral Intervention to Improve Physical Activity, Sleep and Cognition in Sedentary Older Adults
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 smartwatch 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Sleep
Intervention  ICMJE
  • 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 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: 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: ELDERFITNESS
  • 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.
    Intervention: Other: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 16, 2021)
115
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
94
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Junxin Li, PhD 410-502-2608 Junxin.li@jhu.edu
Contact: Lena Sciarratta, BS 410-929-5259 Lsciarr1@jhu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959202
Other Study ID Numbers  ICMJE IRB00198497
R00NR016484 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Junxin Li, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP