Home-Based Rehabilitation + Health Coaching for Post-Intensive Care Syndrome

Recruiting at 1 trial location

Overseen By Johanna Hoult

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Psychiatric disorders, Substance abuse, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

220 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to gather information on the effectiveness of a home-based rehabilitation program that also includes health coaching in patients who may suffer from post-intensive care syndrome (PICS). Many patients who are admitted to a hospital ICU suffer from new or worsening symptoms related to their medical condition and ICU care. These new or worsening symptoms may persist for some time and are collectively called post-intensive care syndrome (PICS).

Will I have to stop taking my current medications?

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.

What data supports the effectiveness of the treatment Home-Based Rehabilitation + Health Coaching for Post-Intensive Care Syndrome?

Research suggests that early physical rehabilitation can be promising for improving outcomes in ICU survivors, although results for later interventions are mixed. Home-based rehabilitation programs are recognized as important, but evidence on their effectiveness is still limited and unclear. ^{1 2 3 4 5}

Is home-based rehabilitation with health coaching safe for humans?

The studies reviewed suggest that home-based rehabilitation programs, including exercise and health coaching, are generally safe for ICU survivors. Participants reported benefits like increased energy and confidence, with no significant safety concerns mentioned. ^{3 5 6 7 8}

How is the home-based rehabilitation and health coaching treatment for Post-Intensive Care Syndrome different from other treatments?

This treatment is unique because it combines home-based physical rehabilitation with health coaching, allowing patients to recover in their own homes with personalized support. Unlike traditional rehabilitation, it includes trainer visits and telephone follow-ups, which are tailored to individual needs, making it more flexible and potentially more accessible for patients. ^{3 4 5 6 9}

Research Team

Rodrigo Cartin-Ceba, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults over 18 who've been in the ICU for more than 48 hours due to severe conditions like respiratory failure, shock, delirium, or cardiac arrest. They should have a certain score indicating they might have PICS but can't join if they've had recent mechanical ventilation, extensive ICU stays, are on palliative care, have uncontrolled mental health issues or substance abuse problems.

Inclusion Criteria

I am an adult who was in the ICU for over 48 hours due to severe illness.

A HABC-M-SR score > 12 points.

Exclusion Criteria

I have not been on a breathing machine in the last two months before my recent ICU stay.

I am currently receiving care focused on relieving symptoms and improving quality of life.

I do not have a severe health condition that would stop me from fully participating in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Phase

5-10 subjects will complete 20 minutes of Home-based Physical Rehabilitation and Health Coaching to test feasibility

12 weeks

Treatment

Participants receive 20 minutes of Home-based Physical Rehabilitation and Health Coaching

12 weeks

Follow-up

Participants are monitored for changes in sedentary time, physical activity, sleep time, cognition, healthcare utilization, quality of life, anxiety, depression, PTSD symptoms, and daily steps

3 months

Treatment Details

Interventions

• Health Coaching
• Home-based Physical Rehabilitation

Trial Overview The study tests how effective a home-based rehabilitation program with health coaching is for patients suffering from post-intensive care syndrome (PICS), which includes persistent symptoms following an intensive hospital stay.

Participant Groups

Group I: Piolt (Aim 1) Group: Home-Based Program of Rehabilitation and Health Coaching Experimental Treatment 1 Intervention

5-10 subjects will be assigned to complete 20 minutes of Home-based Physical Rehabilitation and Health Coaching for approximately 12 weeks to test feasibility of the home-based rehabilitation program. This will be the initial phase of the study prior to RCT phase.

Group II: Home-Based Program of Rehabilitation and Health Coaching Experimental Treatment 2 Interventions

Subjects will complete 20 minutes of Home-based Physical Rehabilitation and Health Coaching for approximately 12 weeks.

Group III: Usual Care Active Control 1 Intervention

Subjects will receive clinical standard of care.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

The PRACTICE study aims to create a core outcome set (COS) for physical rehabilitation interventions in critically ill patients, addressing the variability in outcomes that complicates research synthesis and clinical application.

Using a mixed methods approach, including systematic reviews and stakeholder consensus, the study seeks to identify key outcomes that will improve the design and effectiveness of future rehabilitation trials for patients transitioning from intensive care to community reintegration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Rehabilitation Core Outcomes In Critical illness (PRACTICE): protocol for development of a core outcome set. Connolly, B., Denehy, L., Hart, N., et al.[2021]

Survivors of critical illness often experience post-intensive care syndrome (PICS), which includes a range of physical, cognitive, psychological, and existential health issues, highlighting the need for targeted interventions.

Early physical rehabilitation and case management interventions show promise in improving long-term outcomes for ICU survivors, while late interventions have had mixed results, indicating the importance of timely and tailored care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approaches to Addressing Post-Intensive Care Syndrome among Intensive Care Unit Survivors. A Narrative Review. Brown, SM., Bose, S., Banner-Goodspeed, V., et al.[2020]

A novel home-based physiotherapy program for survivors of critical illness was tested, but it showed no significant difference in outcome measures at the 26-week follow-up, indicating that this specific intervention may not be effective for improving post-ICU morbidity.

The study highlights the importance of tailoring post-ICU rehabilitation programs to individual patient and family needs, suggesting that a broader range of outcome measures could provide better insights into the effectiveness of such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The challenge of designing a post-critical illness rehabilitation intervention. Herridge, MS.[2022]

This randomized controlled trial will assess the effectiveness of an 8-week home-based rehabilitation program for survivors of critical illness, focusing on improving physical and psychological recovery after hospital discharge.

With a target sample size of 200 participants, the study aims to demonstrate a clinically significant 10% improvement in physical functioning, potentially providing a scalable model for enhancing recovery in aging populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol: home-based physical rehabilitation for survivors of a critical illness [ACTRN12605000166673]. Elliott, D., McKinley, S., Alison, JA., et al.[2018]

The REACH program, an interdisciplinary home-based rehabilitation intervention for patients with Post-Intensive Care Syndrome (PICS), was found to be feasible and well-received, with 79.1% of participants completing the 6-month follow-up without any adverse events.

Patients in the REACH group reported higher satisfaction and a larger number of visits to allied health professionals compared to those receiving usual care, although both groups showed similar recovery in functional outcomes and health-related quality of life at 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a home-based interdisciplinary rehabilitation program for patients with Post-Intensive Care Syndrome: the REACH study. Major, ME., Dettling-Ihnenfeldt, D., Ramaekers, SPJ., et al.[2023]

An eight-week home-based physical rehabilitation program for critically ill survivors did not significantly enhance recovery compared to a control group, as both groups showed similar improvements in physical function over 26 weeks.

Despite the lack of significant differences between the intervention and control groups, both experienced clinically important gains in physical function and endurance, suggesting that some level of recovery occurs naturally after critical illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related quality of life and physical recovery after a critical illness: a multi-centre randomised controlled trial of a home-based physical rehabilitation program. Elliott, D., McKinley, S., Alison, J., et al.[2023]

The study involving 20 ICU survivors showed that an exercise intervention using rhythmic music was both feasible and acceptable, indicating that patients could effectively self-manage their exercise routines with personalized playlists.

Participants reported general, physical, and psychosocial benefits from the music intervention, suggesting it could be a valuable tool for rehabilitation in ICU survivors, warranting further investigation in larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a self-managed exercise to rhythmic music intervention for ICU survivors. Liang, Z., Munro, CL., Ferreira, TBD., et al.[2021]

The PIX study found that a supervised exercise program significantly improved fitness and suggested benefits for physical and mental health in patients recovering from critical illness, based on both objective measurements and qualitative feedback.

Participants in the exercise group reported increased motivation, energy levels, and social interaction, highlighting the positive impact of structured exercise on their overall well-being and quality of life after hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Project Post Intensive Care eXercise (PIX): A qualitative exploration of intensive care unit survivors' perceptions of quality of life post-discharge and experience of exercise rehabilitation. Walker, W., Wright, J., Danjoux, G., et al.[2021]

Early rehabilitation practices, including tailored physical therapy and exercise, are effective and safe for improving functional outcomes and quality of life in adult ICU survivors, as supported by a systematic review of current research.

Despite the benefits, critically ill patients often do not receive standard physical therapy, highlighting the need for critical care nurses to advocate for and implement early rehabilitation practices in ICU settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early rehabilitation in the intensive care unit: an integrative literature review. Sosnowski, K., Lin, F., Mitchell, ML., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Physical Rehabilitation Core Outcomes In Critical illness (PRACTICE): protocol for development of a core outcome set. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Approaches to Addressing Post-Intensive Care Syndrome among Intensive Care Unit Survivors. A Narrative Review. [2020]

3. England pubmed.ncbi.nlm.nih.gov

The challenge of designing a post-critical illness rehabilitation intervention. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Study protocol: home-based physical rehabilitation for survivors of a critical illness [ACTRN12605000166673]. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Feasibility of a home-based interdisciplinary rehabilitation program for patients with Post-Intensive Care Syndrome: the REACH study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Health-related quality of life and physical recovery after a critical illness: a multi-centre randomised controlled trial of a home-based physical rehabilitation program. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a self-managed exercise to rhythmic music intervention for ICU survivors. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Project Post Intensive Care eXercise (PIX): A qualitative exploration of intensive care unit survivors' perceptions of quality of life post-discharge and experience of exercise rehabilitation. [2021]

9. Australia pubmed.ncbi.nlm.nih.gov

Early rehabilitation in the intensive care unit: an integrative literature review. [2022]