Clinical trial NCT03959202: A Personalized Behavioral Intervention to Improve Physical Activity, Sleep and Cognition in Sedentary Older Adults
Official title: A Personalized Behavioral Intervention to Improve Physical Activity, Sleep and Cognition in Sedentary Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sleep
Keywords: older adults
exercise intervention
cognition
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-05-22
Enrollment: 129
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Change in Objective Sleep Duration
timeFrame: Week 1, Week 26 intact cognition or Week 18 for mild cognitive impairment (MCI)
measure: Change in Sleep Efficiency as Assessed by Actigraphy
timeFrame: Week 1, Week 26 intact cognition or Week 18 for MCI
measure: Change in Subjective Sleep Quality as Assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Week 1, Week 26 intact cognition or Week 18 for MCI
measure: Change in Plasma tumor necrosis factor-α (TNF-α)
timeFrame: Week 1, Week 26 intact cognition or Week 18 for MCI
measure: Change in Plasma C-reactive protein (CRP)
timeFrame: Week 1, Week 26 intact cognition or Week 18 for MCI
measure: Change in Plasma interleukin-6 (IL-6)
timeFrame: Week 1, Week 26 intact cognition or Week 18 for MCI
measure: Change in Plasma interleukin-1ß (IL-1ß)
timeFrame: Week 1, Week 26 intact cognition or Week 18 for MCI
measure: Change in Global Cognition As Assessed by The Cogstate Brief Battery (CBB)
timeFrame: Week 1, Week 26 intact cognition or Week 18 for MCI
measure: Change in Physical Activity (PA) as Assessed by Actigraphy
timeFrame: Week 1, Week 26 intact cognition or Week 18 for MCI
measure: Change in Physical Activity (PA) as assessed by the Physical Activity Scale for the Elderly
timeFrame: Week 1, Week 26 intact cognition or Week 18 for MCI
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Junxin Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: