← Back to Search

Behavioural Intervention

Cycle Ergometry for Critical Illness Recovery (ASPIRE Trial)

N/A
Waitlist Available
Led By Rita Bakhru, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Acute Hypoxic respiratory failure on mechanical ventilation for <48 hours with a P:F ratio of <300 (or equivalent S:F ratio)
Age ≥55 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (hospital discharge, 3 months post-discharge, 6 months post-discharge)
Awards & highlights

ASPIRE Trial Summary

This trial will test whether a new rehabilitation therapy given early to critically ill patients will improve their outcomes and change the course of their recovery.

Who is the study for?
This trial is for people aged 55 or older who are in the ICU with severe breathing problems and have been on a ventilator for less than 48 hours. They must have been able to walk before their illness and weigh under 150 kg. People can't join if they're pregnant, don't speak English, have certain muscle or joint issues, recent heart surgery, high brain pressure, or are not expected to survive.Check my eligibility
What is being tested?
The study tests whether starting rehabilitation therapy early in critically ill patients using a cycle ergometer (a type of stationary bike) improves their recovery. It aims to see if this approach helps patients regain function faster compared to usual care practices.See study design
What are the potential side effects?
While specific side effects aren't listed for cycling exercise, potential risks may include fatigue, discomfort while exercising, and possibly muscle strain due to physical activity during critical illness.

ASPIRE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been on a ventilator for less than 48 hours due to severe breathing issues.
Select...
I am 55 years old or older.
Select...
I have been able to walk 4 meters with or without help in the last 3 months.

ASPIRE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (hospital discharge, 3 months post-discharge, 6 months post-discharge)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (hospital discharge, 3 months post-discharge, 6 months post-discharge) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients in the intervention arm the are able to undergo a cycling session
Secondary outcome measures
Accelerometer Activity Monitoring Results
Handgrip strength
Hospital Length of Stay
+9 more

ASPIRE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.
Group II: Usual CareActive Control1 Intervention
The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
317 Previous Clinical Trials
392,658 Total Patients Enrolled
1 Trials studying Critical Illness
142 Patients Enrolled for Critical Illness
Wake Forest University Health SciencesLead Sponsor
1,231 Previous Clinical Trials
1,001,787 Total Patients Enrolled
10 Trials studying Critical Illness
4,489 Patients Enrolled for Critical Illness
National Institute on Aging (NIA)NIH
1,656 Previous Clinical Trials
28,004,174 Total Patients Enrolled
14 Trials studying Critical Illness
6,372 Patients Enrolled for Critical Illness

Media Library

Cycle Ergometry (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT02963558 — N/A
Critical Illness Research Study Groups: Intervention, Usual Care
Critical Illness Clinical Trial 2023: Cycle Ergometry Highlights & Side Effects. Trial Name: NCT02963558 — N/A
Cycle Ergometry (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02963558 — N/A

Frequently Asked Questions

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

Is the recruitment process for this trial still open?

"The recruitment phase for this trial is currently ongoing. Clinicaltrials.gov first listed it on May 30th 2017, and the listing was revised most recently on June 8th 2022."

Answered by AI

How many individuals are partaking in this medical study presently?

"Affirmative. According to the details presented on clinicaltrials.gov, this research project--first published in May 2017 and recently modified June 8th 2022--is actively enlisting participants from a single trial site with 42 individuals needed for recruitment."

Answered by AI
Recent research and studies
~0 spots leftby May 2024