Pain, Sleep
Conditions
Brief summary
It is well recognized that physical activity/exercise is an effective intervention to improve sleep, reduce pain and improve function in a variety of pain conditions. Traditional interventions to increase physical activity are challenging in older adults due to extensive staffing requirements and low adherence. The investigators plan to conduct a pilot trial in a cohort of older adults (without dementia) with both chronic musculoskeletal pain and nocturnal sleep complaints to test the effectiveness of a 12-week personalized behavioral intervention (compared to a control group) embedded within a smartwatch application in older adults. 27 cognitively intact elders were enrolled and randomly allocated to intervention or control group. Participants in the intervention arm received 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 received general education on physical activity in older adults and continue routine daily activity for 12 weeks.
Interventions
BEHAVIORALELDERFITNESS
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.
OTHERControl
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
National Institute of Nursing Research (NINR)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Intact cognition * Poor sleep quality * Self-reported presence of pain * Capacity for mild to moderate physical activity.
Exclusion criteria
* Non-ambulatory or have severely impaired mobility, * Visual or hearing impairment that interfered with assessments, and * An acute or a terminal illness * Neuropathic pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Objective Sleep Duration | Week 1, Week 14 | Total sleep time (minutes) will be measured using actigraph |
| Change in Sleep Efficiency as Assessed by Actigraphy | Week 1, Week 14 | Sleep efficiency (reported as a percentage)will be measured using actigraph |
Countries
United States
Participant flow
Recruitment details
The recruitment was started in July 2019 and was completed in February 2020 with 27 enrollments. We recruited at the geriatric clinic at the John Hopkins Bayview and community senior centers in Baltimore city.
Pre-assignment details
24 of the 27 enrolled participants were randomly assigned to the intervention and control groups. 3 of the 27 enrolled participants withdrew from the study before completing baseline sleep data collection and group assignment
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 12 |
| Control The control group will receive 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.
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. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 11 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Continuous | 72.9 years STANDARD_DEVIATION 7.2 | 73.2 years STANDARD_DEVIATION 7.1 | 73.0 years STANDARD_DEVIATION 7.5 |
| Body Mass Index | 31.2 kg/m2 STANDARD_DEVIATION 3.3 | 30.2 kg/m2 STANDARD_DEVIATION 6.2 | 30.7 kg/m2 STANDARD_DEVIATION 4.9 |
| Education_Some college or higher | 9 Participants | 11 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 5 Participants | 5 Participants | 10 Participants |
| Region of Enrollment United States | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Change in Objective Sleep Duration
Total sleep time (minutes) will be measured using actigraph
Time frame: Week 1, Week 14
Population: 12 participants were assigned to the intervention group. One participant withdrew during the intervention. There were 11 participants in the invention group were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Objective Sleep Duration | 19 MINUTE | Standard Deviation 41.2 |
| Control | Change in Objective Sleep Duration | 2.5 MINUTE | Standard Deviation 30.3 |
Primary
Change in Sleep Efficiency as Assessed by Actigraphy
Sleep efficiency (reported as a percentage)will be measured using actigraph
Time frame: Week 1, Week 14
Population: 12 participants were assigned to the intervention group. One participant withdrew during the intervention. There were 11 participants in the invention group were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Sleep Efficiency as Assessed by Actigraphy | 5.1 percent | Standard Deviation 3.9 |
| Control | Change in Sleep Efficiency as Assessed by Actigraphy | -0.8 percent | Standard Deviation 8.4 |