Clinical trial NCT05568511: Home-based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors - HEAL Sepsis Trial
Official title: Home-based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors - HEAL Sepsis Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exercise Program
Standard Care Control
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-10-05
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility (adherence - number of performed exercise sessions; retention - number of participants to complete the study).
timeFrame: Change from Baseline to 1 month and then 3 months
measure: Safety (number of adverse events)
timeFrame: Change from Baseline to 1 month and then 3 months
Secondary outcomes:
measure: Physical function
timeFrame: Change from Baseline to 3 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Clinical and Translational Research Building
state: Florida
Study officials:
affiliation: University of Florida
name: Robert Mankowski, PhD
role: PRINCIPAL_INVESTIGATOR
References: