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Digital Exercise Program for Sepsis Survivors

N/A
Recruiting
Led By Robert Mankowski, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
SPPB ≤ 6
Being discharged to home from the hospital after surviving sepsis
Must not have
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
Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to help older sepsis survivors who have poor physical function by offering them remote exercise interventions. The study plans to recruit these survivors at discharge from the hospital and assign them to either exercise

Who is the study for?
This trial is for older adults, aged 55 and above, who have survived sepsis and are being discharged home from the hospital. They should be able to do basic body movements but have a low physical function score (SPPB ≤ 6). Participants must be willing to use technology for the study and agree to be randomly assigned to either the exercise program or standard care.
What is being tested?
The HEAL Sepsis Trial is testing if a home-based digital exercise program can improve physical function in older sepsis survivors compared with those receiving standard post-sepsis care. The exercise routine is delivered through an app, aiming at convenient access for participants.
What are the potential side effects?
While not explicitly mentioned, potential side effects of participating in an app-based exercise program may include muscle soreness, fatigue, or injury due to physical activity. Standard care typically does not involve such risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My physical abilities are significantly limited.
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I am going home after being in the hospital for sepsis.
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I am 55 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe heart problems like bad heart failure or uncontrolled chest pain.
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I need steroids or extra oxygen for my severe lung condition.
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I cannot do exercises involving my arms or legs.
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I have a worsening neurological condition like Parkinson's or multiple sclerosis.
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I am being discharged to a long-term care facility.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility (adherence - number of performed exercise sessions; retention - number of participants to complete the study).
Safety (number of adverse events)
Secondary study objectives
Physical function

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Home-based, digitally delivered exercise training programExperimental Treatment1 Intervention
Group II: Standard care control groupActive Control1 Intervention

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,397 Previous Clinical Trials
767,020 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,785 Previous Clinical Trials
28,184,696 Total Patients Enrolled
Robert Mankowski, PhDPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
147 Total Patients Enrolled
~2 spots leftby Dec 2024
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