Exercise Program, Standard Care Control
Conditions
Brief summary
Older sepsis survivors have poor physical function and need post-sepsis physical rehabilitation. Often times, sepsis survivors live far from research facilities and do not have access to rehabilitation services. Remotely delivered exercise intervention could be the key to improve physical function in this population. Therefore, the study proposes to recruit older sepsis survivors at discharge from the hospital to home and assign them to either exercise training or standard care.
Detailed description
The proposed research will use a multi-disciplinary expertise of the University of Florida Sepsis and Critical Illness Research Center (SCIRC). For this project, the investigators will take advantage of the SCIRC's ongoing recruitment and monitoring of sepsis patients into an observational 1-year follow-up study. For this pilot, the investigators will approach and screen older sepsis survivors who get discharged from hospital to home. Potential participants will be approached within 5 days before discharge. The study will enroll 40 low-functioning (SPPB \<6) older sepsis patients (≥55 years old). The enrolled subjects will be randomized to either digitally delivered and home-based exercise training program or standard care control group. All participants will receive tablets with the Blue Marble Health Platform (BMHP) app. For the control group, the app will be enabled only for the physical function assessments and for the rest of the time, only a health diary for logging daily activities will be available. Both groups will receive weekly phone calls from our research staff member to ask about their health and remind them of weekly charging of their tablets. The intervention group will receive daily reminders by text to perform the exercises for 30 min daily 5 days/week. Participants will be given wrist fitness tracking watches with step-counting and heart rate to measure adherence to an exercise intervention. At baseline and 12-week follow-up visits physical function assessments will be app-guided using the BMHP-validated physical function test similar to SPPB, with a blinded coordinator present via a video call to assist a participant with answering questions about the tests. The interventionists who will be calling the participants will be trained to maintain the same level of rapport to not jeopardize the study conditions.
Interventions
OTHERApp-based exercise program
Remotely-controlled, app-guided exercise program
OTHERStandard of Care
These participants will follow the usual post-sepsis care after returning to home. The participants will be asked to log their daily activities in the app's health diary. The app will be activated for the baseline and follow-up physical function assessments, which will be supervised be a blinded coordinator via a video call.
Sponsors
University of Florida
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 105 Years
Healthy volunteers
No
Inclusion criteria
* Able to perform lower and upper-body movements * Sepsis survivor * Age 55 years and older * SPPB ≤ 6 * Being discharged to home from the hospital after surviving sepsis * Willingness to be randomized to either treatment or control group * Willingness to participate in all study procedures * Willingness to use the devices and technology in the study
Exclusion criteria
* Failure to provide informed consent * Pregnant * Discharge to a long-term facility * Involvement in a structured rehabilitation program * Inability to perform lower or upper-body exercises (e.g. being in wheelchair) * Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina * Significant cognitive impairment, including known dementia diagnosis or a Mini-Mental State Examination exam score \< 24 * Progressive, degenerative neurologic disease, e.g., Parkinson's Disease, multiple sclerosis * Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen * Simultaneous participation in another intervention trial * Poor or no cellular internet service at the primary place of living.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Adherence | Baseline to 3 months | Assessment of adherence to exercise intervention - percentage of performed exercise sessions. |
| Safety (Number of Adverse Events) | Baseline to 3 months | Recording a number of adverse events during the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-second Sit-to-Stand Test | Change between Baseline and 3 months | Application-guided physical function testing. The 30-second sit-to-stand test assesses lower-body strength and functional mobility by measuring the number of times a participant can rise from a seated position to a full stand and return to sitting within 30 seconds. |
| 4-Stage Balance Test | Change between Baseline and 3 months | Application-guided physical function testing. The 4-stage balance test assesses static balance by evaluating a participant's ability to maintain four progressively challenging standing positions for up to 10 seconds each. Successful completion of more advanced stages indicates better balance and postural control. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert Mankowski, PhD
University of Florida
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 72.3 years old STANDARD_DEVIATION 7.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
| Total Sequential Organ Failure Assessment (SOFA) score | 2.9 scores on a scale STANDARD_DEVIATION 0.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 10 | 0 / 11 |
| other Total, other adverse events | 6 / 10 | 7 / 11 |
| serious Total, serious adverse events | 1 / 10 | 1 / 11 |
Outcome results
None listed