IMT Outcomes in Sufferers of Severe Walking Disabilities and Intensive Care Unit Acquired Weakness

January 8, 2024 updated by: Ali Mohamed Ali ismail, Cairo University

Inspiratory Muscle Training Outcomes in Sufferers of Severe Walking Disabilities and Intensive Care Unit Acquired Weakness

Intensive care unit-acquired weakness (ICU-acquired weakness) may be caused by a variety of different causes. Several studies have shown that ICU-acquired weakness occurs in up to 30% of critically ill patients. It affects daily activities, walking, and functional performance

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Forty ICU-acquired weakness elderly patients will be randomly assigned to group A and group B, 20 elderly for each. Both groups will receive chest physiotherapy (cough training, vibration, percussion, rib springing, and postural drainage), 30 minutes of resisted training on upper- and lower-limb muscles (15 min on upper limb and 15 min on lower limb), and 30 minutes of neuromuscular electrical stimulation of lower- and upper-limb muscles (triceps and wrist extensors, dorsiflexors, and quadriceps). sessions will be executed 5 times weekly). Group A only will receive 3-set IMT (two sessions daily via threshold IMT, the set contain 10 repetitions) 5 times weekly. The study duration will be 1 month.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Cairo Unoversity
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • sufferers with intensive care unit acquired weakness
  • Older sufferers patients with severe walking disability detected by Modified Functional Ambulation Category test,

Exclusion Criteria:

  • lower limb amputations
  • orthopedic or spinal disc disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: group A
twenty ICU-acquired weakness elderly patients will receive chest physiotherapy (cough training, vibration, percussion, rib springing, and postural drainage), 30 minutes of resisted training on upper- and lower-limb muscles (15 min on upper limb and 15 min on lower limb), and 30 minutes of neuromuscular electrical stimulation of lower- and upper-limb muscles (triceps and wrist extensors, dorsiflexors, and quadriceps). sessions will be executed 5 times weekly). this Group will receive 3-set IMT (two sessions daily via threshold IMT, the set contain 10 repetitions) 5 times weekly. The study duration will be 1 month.
Behavioral: Threshold IMT and traditional physical therapy program
twenty ICU-acquired weakness elderly patients will receive chest physiotherapy (cough training, vibration, percussion, rib springing, and postural drainage), 30 minutes of resisted training on upper- and lower-limb muscles (15 min on upper limb and 15 min on lower limb), and 30 minutes of neuromuscular electrical stimulation of lower- and upper-limb muscles (triceps and wrist extensors, dorsiflexors, and quadriceps). sessions will be executed 5 times weekly). this Group will receive 3-set IMT (two sessions daily via threshold IMT, the set contain 10 repetitions) 5 times weekly. The study duration will be 1 month.
Active Comparator: group B
twenty ICU-acquired weakness elderly patients will receive chest physiotherapy (cough training, vibration, percussion, rib springing, and postural drainage), 30 minutes of resisted training on upper- and lower-limb muscles (15 min on upper limb and 15 min on lower limb), and 30 minutes of neuromuscular electrical stimulation of lower- and upper-limb muscles (triceps and wrist extensors, dorsiflexors, and quadriceps). sessions will be executed 5 times weekly). The study duration will be 1 month.
Behavioral: traditional physiotherapy program
twenty ICU-acquired weakness elderly patients will receive chest physiotherapy (cough training, vibration, percussion, rib springing, and postural drainage), 30 minutes of resisted training on upper- and lower-limb muscles (15 min on upper limb and 15 min on lower limb), and 30 minutes of neuromuscular electrical stimulation of lower- and upper-limb muscles (triceps and wrist extensors, dorsiflexors, and quadriceps). sessions will be executed 5 times weekly).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Modified Functional Ambulation Category Test
Time Frame: it will be measured after 1 month
it is a category test used to assess walking disability
it will be measured after 1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
functional vital capacity
Time Frame: It will be measured after 1 month
the percentage of predicted value of functional vital capacity will be assessed
It will be measured after 1 month
forced expiatory volume in the first second of expiration
Time Frame: It will be measured after 1 month
the percentage of predicted value of FEV1 will be assessed
It will be measured after 1 month
Partial Pressure of Oxygen
Time Frame: It will be measured after 1 month
it is an arterial blood gas test
It will be measured after 1 month
Partial Pressure of carbon dioxide
Time Frame: It will be measured after 1 month
it is an arterial blood gas test
It will be measured after 1 month
Oxygen saturation
Time Frame: It will be measured after 1 month
it is an arterial blood gas test
It will be measured after 1 month
inspiratory muscle strength
Time Frame: It will be measured after 1 month
it will be measure in cm H2O
It will be measured after 1 month
expiratory muscle strength
Time Frame: It will be measured after 1 month
it will be measure in cm H2O
It will be measured after 1 month
time up and go test
Time Frame: It will be measured after 1 month
it is time used to walk a three-meter distance
It will be measured after 1 month
30-second sit to stand
Time Frame: It will be measured after 1 month
number of (sit to stand) done in 30 seconds
It will be measured after 1 month
six-minute walk test,
Time Frame: It will be measured after 1 month
distance walked in 6 minute
It will be measured after 1 month
10-meter walking test
Time Frame: It will be measured after 1 month
it is time used to walk a 10-meter distance
It will be measured after 1 month
mental division of short form 36
Time Frame: It will be measured after 1 month
it assess mental component of short form 36 quality of life questionnare
It will be measured after 1 month
physical division of short form 36
Time Frame: It will be measured after 1 month
it assess physical component of short form 36 quality of life questionnare
It will be measured after 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ali MA Ismail, lecturer, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/004624

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings