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Home-based, digitally delivered exercise training program for Exercise Program

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility (adherence - number of performed exercise sessions; retention - number of participants to complete the study).

Safety (number of adverse events)

Secondary outcome measures

Physical function

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,343 Previous Clinical Trials

716,433 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,682 Previous Clinical Trials

28,026,146 Total Patients Enrolled

Robert Mankowski, PhDPrincipal InvestigatorUniversity of Florida

1 Previous Clinical Trials

49 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants being selected for enrollment in this clinical trial?

"Affirmative. The details on clinicaltrials.gov affirm that this trial is actively pursuing participants. It was first listed on 3/29/2023 and last revised on 4/19/2024, aiming to enroll 40 individuals from a single site."

Answered by AI

Are patients currently being sought for enrollment in this medical study?

"As documented on clinicaltrials.gov, this medical investigation is presently in the process of identifying suitable participants. The trial was first made public on March 29th, 2023, and received its most recent update on April 19th, 2024."

Answered by AI

Is the clinical trial accepting participants who are older than 65 years of age?

"Eligible candidates for this research project must fall between the ages of 55 and 105. Interestingly, there are a total of 41 trials catering to individuals under 18 years old and another 153 focused on those above 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Home-based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors - HEAL Sepsis Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05568511.

All > Sepsis