209 Participants Needed

Muscle Recovery for Critical Illness

(TRACER Trial)

Recruiting at 2 trial locations
KP
DL
Overseen ByDoug Long, MS
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Kirby Mayer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand muscle recovery in individuals who have survived critical illnesses, such as serious infections or severe breathing problems. Researchers will examine muscle recovery over time and identify factors linked to ongoing physical challenges. The study will test various therapies, including occupational therapy (also known as occupational rehabilitation or ergotherapy) and physical therapy, to determine which is most effective for muscle recovery. Candidates include those who have spent at least 72 hours in the ICU due to conditions like sepsis or severe breathing issues and are able to walk.

As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that both occupational therapy and physical therapy are safe and well-tolerated. Occupational therapy helps individuals regain skills needed for daily activities. Research indicates it plays a key role in ensuring safety and reducing mistakes, with no significant negative effects reported.

Physical therapy often includes exercise programs to aid recovery. Studies have shown that these exercise programs are generally safe for individuals recovering from serious illness, with no major negative effects noted. Both therapies aim to improve physical function and quality of life, making them a safe option for those recovering from severe illness.12345

Why are researchers excited about this trial?

Researchers are excited about using occupational and physical therapy for muscle recovery after critical illness because these therapies focus directly on rebuilding strength and functionality, rather than just managing symptoms. Unlike standard drug treatments that might aim to reduce inflammation or pain, these therapies involve active participation and personalized exercises tailored to each patient's needs. This hands-on approach not only targets muscle rebuilding but also enhances overall patient well-being and independence, potentially leading to faster recovery times and a better quality of life.

What evidence suggests that this trial's treatments could be effective for muscle recovery after critical illness?

Research has shown that occupational therapy, which participants in this trial may receive, can greatly help people improve their ability to handle everyday tasks. One study found that it not only boosts performance but also increases satisfaction with daily activities. Additionally, occupational therapy has significantly aided those recovering from various disabilities.

Similarly, physical therapy, another treatment option in this trial, has greatly improved physical abilities and muscle strength. Studies indicate that most patients experience significant progress. Furthermore, engaging in therapy before major surgery, known as prehabilitation, can enhance strength and quality of life. Both therapies have strong evidence supporting their effectiveness in helping people regain muscle and physical function.678910

Who Is on the Research Team?

KP

Kirby P Mayer, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

Inclusion Criteria

admission for sepsis or acute respiratory failure with at least 72 hour stay in ICU
adult (>18 y/o)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo interventions to assess muscle and physical function recovery after critical illness

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Occupational Therapy
  • Physical Therapy
  • Standard of Care

Occupational Therapy is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Occupational Therapy for:
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Approved in European Union as Occupational Therapy for:
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Approved in Canada as Occupational Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kirby Mayer

Lead Sponsor

Trials
4
Recruited
250+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials
508
Recruited
1,090,000+

University of Alabama at Birmingham

Collaborator

Trials
1,677
Recruited
2,458,000+

Oklahoma Medical Research Foundation

Collaborator

Trials
24
Recruited
8,400+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39506871/

Value-based outcome evaluation methods used by ...

This scoping review aimed to map how occupational therapists evaluate the outcomes of services they provide within primary care.

Quality indicators for occupational therapy: a scoping review

We identified and described process-level indicators, functional outcome indicators, one outcome indicator based on individual goal attainment ( ...

Occupational Therapy Intervention for Improvement of Activity ...

Data on intervention strategies, outcome measures, and research designs were extracted and categorized by using qualitative methods. Findings: ...

effectiveness of ergotherapeutic and occupational ...

Results: The data from the study show a statistically significant positive impact of the selected ergo- and occupational therapy program in ...

Effectiveness of occupational therapy interventions on ...

Occupational therapy resulted in an improvement in satisfaction with occupational performance as measured by the COPM (REM, SMD 0.74, 95% CI ...

What are the common areas of risk and their characteristics ...

25 journal articles were identified and arranged into 10 risk domains: Falls, discharge, practice errors, activities of daily living, pressure care, frailty ...

Improving Client Safety: Strategies to Prevent and Reduce ...

This qualitative focus group study investigated the strategies to prevent or reduce practice errors used by occupational therapists who practice in physical ...

Enhancing Visual Safety in OT for Work and Home

Occupational therapy is integral to the process of visual safety assessment, both in the workplace and at home. We evaluate how clients perceive ...

The Power of Occupational Therapy in Ergonomics - St. Kate

Ergonomics is the study of health and safety in work environments. Using ergonomic techniques, such as postural adjustments and office ...

Ergotherapy, the Occupational Therapy as an Aid to Return ...

Occupational therapy is the branch of rehabilitation whose main aim is to achieve maximum possible autonomy of the disabled person.