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Combined Rehab Therapy for Acquired Weakness (ProMoTE Trial)

Q: Am I eligible to take part in this scientific research?

This trial is recruiting 78 elderly individuals (aged 60 to 99) suffering from sarcopenia. Prerequisites include recent LTACH admission, two weeks of prior ICU stay, understanding English commands and granting consent, a Barthel Index score above 70, ability to perform physical therapy exercises and having <a href="https://www.withpower.com/clinical-trials/all">all</a> four limbs intact and <a href="https://www.withpower.com/clinical-trials/mobile">mobile</a> pre-LTACH admission.

Q: Are there any opportunities for participation in this experiment currently available?

Contrary to what is available on clinicaltrials.gov, this study has stopped enrolling participants, with the first posting dating back to November 1st 2022 and the last edit made on April 6th of 2022. However, there are 276 other medical trials that patients may be able to participate in at present.

Q: Does this clinical trial accept participants older than 35 years of age?

This trial is actively seeking seniors aged between 60 and 99.

Q: What are the projected results expected to be from this clinical investigation?

The primary assessment for this clinical trial will occur on Days 0, 7, 14, 21 and 28 with the aim of measuring changes in muscle mass. Secondary objectives include assessing functional status via FSS-ICU scores; mobility status using a 1-item ICU Mobility Scale; as well as patient discharge disposition (home/nursing home/acute rehabilitation).

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

ProMoTE Trial 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.Check my eligibility

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.See study design

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.

ProMoTE Trial 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.

ProMoTE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Muscle mass

Muscle Tissue

Change in Systemic Inflammation

Secondary outcome measures

Change in Functional status - FSS-ICU

Change in Functional status - SPPB

Change in Mobility status - 6 minute walk distance

+3 more

ProMoTE 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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

687 Previous Clinical Trials

374,568 Total Patients Enrolled

Media Library

High Protein Supplement (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05326633 — Phase < 1

Acquired Weakness Research Study Groups: MRP+HPRO+NMES+UC, UC only

Acquired Weakness Clinical Trial 2023: High Protein Supplement Highlights & Side Effects. Trial Name: NCT05326633 — Phase < 1

High Protein Supplement (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05326633 — Phase < 1

Frequently Asked Questions

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

Am I eligible to take part in this scientific research?

"This trial is recruiting 78 elderly individuals (aged 60 to 99) suffering from sarcopenia. Prerequisites include recent LTACH admission, two weeks of prior ICU stay, understanding English commands and granting consent, a Barthel Index score above 70, ability to perform physical therapy exercises and having all four limbs intact and mobile pre-LTACH admission."

Answered by AI

Are there any opportunities for participation in this experiment currently available?

"Contrary to what is available on clinicaltrials.gov, this study has stopped enrolling participants, with the first posting dating back to November 1st 2022 and the last edit made on April 6th of 2022. However, there are 276 other medical trials that patients may be able to participate in at present."

Answered by AI

Does this clinical trial accept participants older than 35 years of age?

"This trial is actively seeking seniors aged between 60 and 99."

Answered by AI

What are the projected results expected to be from this clinical investigation?

"The primary assessment for this clinical trial will occur on Days 0, 7, 14, 21 and 28 with the aim of measuring changes in muscle mass. Secondary objectives include assessing functional status via FSS-ICU scores; mobility status using a 1-item ICU Mobility Scale; as well as patient discharge disposition (home/nursing home/acute rehabilitation)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older ICU Survivors

Avelino Verceles 2024. "Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older ICU Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05326633.

All > Sarcopenia