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

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Conditions

Exercise ProgramStandard Care Control

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-29
Study Completion:2025-07-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05568511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 105 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to perform lower and upper-body movements
  2. * Sepsis survivor
  3. * Age 55 years and older
  4. * SPPB ≤ 6
  5. * Being discharged to home from the hospital after surviving sepsis
  6. * Willingness to be randomized to either treatment or control group
  7. * Willingness to participate in all study procedures
  8. * Willingness to use the devices and technology in the study
  1. * Failure to provide informed consent
  2. * Pregnant
  3. * Discharge to a long-term facility
  4. * Involvement in a structured rehabilitation program
  5. * Inability to perform lower or upper-body exercises (e.g. being in wheelchair)
  6. * 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
  7. * Significant cognitive impairment, including known dementia diagnosis or a Mini-Mental State Examination exam score \< 24
  8. * Progressive, degenerative neurologic disease, e.g., Parkinson's Disease, multiple sclerosis
  9. * Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen
  10. * Simultaneous participation in another intervention trial
  11. * Poor or no cellular internet service at the primary place of living.

Contacts and Locations

Principal Investigator

Robert Mankowski, PhD
PRINCIPAL_INVESTIGATOR
University of Florida

Study Locations (Sites)

UF Clinical and Translational Research Building
Gainesville, Florida, 32611
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Robert Mankowski, PhD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-29
Study Completion Date2025-07-29

Study Record Updates

Study Start Date2023-03-29
Study Completion Date2025-07-29

Terms related to this study

Additional Relevant MeSH Terms

  • Exercise Program
  • Standard Care Control