SleepPhase 1/2NCT03959202
A Personalized Behavioral Intervention to Improve Physical Activity, Sleep and Cognition in Sedentary Older Adults
A Phase 1/2 study testing ELDERFITNESS in people with Sleep, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- ELDERFITNESS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2019to 28 Feb 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Untreated sleep apnea as diagnosed by polysomnography
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- ELDERFITNESS, Control
- Keywords
- older adults, exercise intervention, cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELDERFITNESSBehavioural
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.
ControlOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Objective Sleep Duration
Total Sleep time (minutes) will be measured using actigraph
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 1, Week 26 intact cognition or Week 18 for MCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start11 Jul 2019
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Junxin Li, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959202
- Sponsor's protocol ID
- IRB00198497
- Other IDs
- R00NR016484
- Status last verified
- Jul 2022
- First submitted
- 20 May 2019
- Last updated
- 8 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu S, Huang J, Calderon R, Spira AP, Mcphillips MV, Gooneratne N, Gill J, Li J. Sleep architecture and self-reported sleep quality are associated with Alzheimer's disease biomarkers in older adults without dementia. J Gerontol A Biol Sci Med Sci. 2026 May 7;81(6):glag081. doi: 10.1093/gerona/glag081.
PubMed 41925207
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized Behavioral Intervention to Improve Physical Activity, Sleep and Cognition in Sedentary Older Adults
- ClinicalTrials.gov ID
- NCT03959202
- Acronym / sponsor ID
- IRB00198497
- Conditions
- Sleep
- Keywords
- older adults, exercise intervention, cognition
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: ELDERFITNESSBased 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. |
| Control | Placebo comparator | Other: ControlThe 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Untreated sleep apnea as diagnosed by polysomnography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELDERFITNESSIn-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. | Behavioural | Intervention |
| ControlGeneral 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 | Other | Control |
Primary outcome
Change in Objective Sleep Duration
Time frame: Week 1, Week 26 intact cognition or Week 18 for mild cognitive impairment (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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Derived from this study: PubMed 41925207Liu S, Huang J, Calderon R, Spira AP, Mcphillips MV, Gooneratne N, Gill J, Li J. Sleep architecture and self-reported sleep quality are associated with Alzheimer's disease biomarkers in older adults without dementia. J Gerontol A Biol Sci Med Sci. 2026 May 7;81(6):glag081. doi: 10.1093/gerona/glag081.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junxin Li, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ELDERFITNESS in people with Sleep, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Objective Sleep Duration (time frame: Week 1, Week 26 intact cognition or Week 18 for mild cognitive impairment (MCI)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03959202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023; AzTrials last refreshed its copy on 1 Nov 2026.