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Combined Rehab Therapy for Acquired Weakness (ProMoTE Trial)

Phase < 1

Waitlist Available

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 60 years old

LTACH admission within 72 hours

Must not have

Diagnosis of active cancer

Acute kidney injury with a glomerular filtration rate <15 ml/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 0, 7, 14, 21 and 28

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an intervention combining physical rehab, protein supplementation, and electrical stimulation to help ICU survivors who are malnourished, weak, and debilitated.

Who is the study for?

This trial is for older ICU survivors aged 60 or above who have been weakened by their stay. They must have been in the ICU for at least two weeks, be able to understand and follow instructions in English, consent to participate, and were mobile before their recent hospital admission. Those with severe organ dysfunction, active cancer, chronic dementia, acute kidney injury or extreme liver issues cannot join.

What is being tested?

The study tests a recovery program combining mobility exercises (MRP), high protein supplements (HPRO), and electric muscle stimulation (NMES) on patients who've lost strength after an ICU stay. It aims to see if this combination helps improve physical function and reduces inflammation-related disability.

What are the potential side effects?

Potential side effects may include discomfort from electric stimulation, muscle soreness from exercise therapy, and digestive changes due to high protein supplements. The severity of these side effects can vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 years old or older.

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I was admitted to a long-term acute care hospital within the last 3 days.

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I have stayed in the ICU for 2 weeks or more.

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I was mostly independent in daily activities before ICU.

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I had all my limbs and could move them before being admitted to long-term care.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with active cancer.

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My kidney function is severely reduced.

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I have severe physical or functional limitations.

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I have severe liver problems, including end-stage disease or cirrhosis.

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I have been diagnosed with long-term memory loss or thinking problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 0, 7, 14, 21 and 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 0, 7, 14, 21 and 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 0, 7, 14, 21 and 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Muscle mass

Muscle Tissue

Change in Systemic Inflammation

Secondary study objectives

Change in Functional status - FSS-ICU

Change in Functional status - SPPB

Change in Mobility status - 6 minute walk distance

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: MRP+HPRO+NMES+UCActive Control1 Intervention

LTACH group receiving mobility based rehabilitation (MRP) + neuromuscular electric stimulation (NMES) + high protein supplementation (HPRO) + usual care (UC)

Group II: UC onlyActive Control1 Intervention

LTACH control group receiving usual care (UC) only.

0 / 10Eligibility criteria met