Home-based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors - HEAL Sepsis Trial

Exercise Program Clinical Trial

Official title:

Home-based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors - HEAL Sepsis Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05568511
• Other study ID #: IRB202200027 -N -R
• Secondary ID: R21AG075645OCR42
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: University of Florida
• Contact: Yi Lin
• Phone: (205) 996-5876
• Email: yi.lin[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 105 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exercise Program
• Sepsis

Intervention

Other:
• App-based exercise program
Remotely-controlled, app-guided exercise program
• Standard 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.

Locations

Country	Name	City	State
United States	UF Clinical and Translational Research Building	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility (adherence - number of performed exercise sessions; retention - number of participants to complete the study).	Assessment of adherence (# of performed exercise sessions) and retention (# of participant that complete the study; # of completed days of the study).	4 months
Primary	Safety (number of adverse events)	Recording a number of adverse events during the study period.	4 months
Secondary	Physical function	Application-guided physical function testing. A test that assesses balance, walking speed and physical performance. Each item will be scored 0-4 (12 total). 0 being the worst and 12 being the best score. the Participants will perform it at their home with our blinded coordinator present via zoom.	4 months