Trial Outcomes & Findings for Development of a Rehabilitation Strengthening and Mobility Program for Ventilator Dependent Older Patients (NCT NCT03195127)

Results Overview

Handgrip strength will be reported in kilograms

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

Upon completing of study, up to 56 days

Results posted on

2023-05-10

Participant Flow

Participant milestones

Participant milestones
Measure	Multimodal Physical Therapy Multimodal physical therapy sessions three times a week, for four weeks, lasting one hour. Consist of limb strengthening exercises, endurance training, and balance/coordination drills. multimodal physical therapy: Consist of limb strengthening exercises, endurance training, and balance/coordination drills. These exercises and training maneuvers may involve the use of handheld weights, nautilus weight equipment, elastic exercise bands, stationary exercise machines (recumbent exercise cycles, hand ergometer cycles), or treadmills. If the subject is fit enough, Tai Chi may be added to as a training method to help improve your balance and strength. In addition, the subject will be asked to wear an accelerometer on their wrist	Usual Care Subjects will receive the standard therapy program provided by University Specialty Hospital therapy services. To compliment the physical therapy regimen, an optimized nutritional program will be administered according accepted guidelines.
Overall Study STARTED	15	18
Overall Study COMPLETED	15	17
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Development of a Rehabilitation Strengthening and Mobility Program for Ventilator Dependent Older Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multimodal Physical Therapy n=15 Participants Multimodal physical therapy sessions three times a week, for four weeks, lasting one hour. Consist of limb strengthening exercises, endurance training, and balance/coordination drills. multimodal physical therapy: Consist of limb strengthening exercises, endurance training, and balance/coordination drills. These exercises and training maneuvers may involve the use of handheld weights, nautilus weight equipment, elastic exercise bands, stationary exercise machines (recumbent exercise cycles, hand ergometer cycles), or treadmills. If the subject is fit enough, Tai Chi may be added to as a training method to help improve your balance and strength. In addition, the subject will be asked to wear an accelerometer on their wrist	Usual Care n=17 Participants Subjects will receive the standard therapy program provided by University Specialty Hospital therapy services. To compliment the physical therapy regimen, an optimized nutritional program will be administered according accepted guidelines.	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	57.1 years STANDARD_DEVIATION 12.0 • n=5 Participants	63.1 years STANDARD_DEVIATION 11.4 • n=7 Participants	60.3 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized African American	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized White	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	17 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: Upon completing of study, up to 56 days

Handgrip strength will be reported in kilograms

Outcome measures

Outcome measures
Measure	Multimodal Physical Therapy n=15 Participants Multimodal physical therapy sessions three times a week, for four weeks, lasting one hour. Consist of limb strengthening exercises, endurance training, and balance/coordination drills. multimodal physical therapy: Consist of limb strengthening exercises, endurance training, and balance/coordination drills. These exercises and training maneuvers may involve the use of handheld weights, nautilus weight equipment, elastic exercise bands, stationary exercise machines (recumbent exercise cycles, hand ergometer cycles), or treadmills. If the subject is fit enough, Tai Chi may be added to as a training method to help improve your balance and strength. In addition, the subject will be asked to wear an accelerometer on their wrist	Usual Care n=17 Participants Subjects will receive the standard therapy program provided by University Specialty Hospital therapy services. To compliment the physical therapy regimen, an optimized nutritional program will be administered according accepted guidelines.
Functional Assessment: Handgrip	3.6 kg Standard Deviation 5.4	1.3 kg Standard Deviation 4.9

PRIMARY outcome

Timeframe: Upon Completion of study, up to 56 days

Population: Male and female survivors of critical illness all meeting criteria for ICU acquired weakness as defined by Stevens.

Short Physical Performance Battery will be reported as a score from 0 to 12 from with lower scores indicating a worse outcome

Outcome measures

Outcome measures
Measure	Multimodal Physical Therapy n=15 Participants Multimodal physical therapy sessions three times a week, for four weeks, lasting one hour. Consist of limb strengthening exercises, endurance training, and balance/coordination drills. multimodal physical therapy: Consist of limb strengthening exercises, endurance training, and balance/coordination drills. These exercises and training maneuvers may involve the use of handheld weights, nautilus weight equipment, elastic exercise bands, stationary exercise machines (recumbent exercise cycles, hand ergometer cycles), or treadmills. If the subject is fit enough, Tai Chi may be added to as a training method to help improve your balance and strength. In addition, the subject will be asked to wear an accelerometer on their wrist	Usual Care n=17 Participants Subjects will receive the standard therapy program provided by University Specialty Hospital therapy services. To compliment the physical therapy regimen, an optimized nutritional program will be administered according accepted guidelines.
Functional Assessment: Short Physical Performance Battery (SPPB)	3.6 units on a scale Standard Deviation 5.4	1.3 units on a scale Standard Deviation 4.9

PRIMARY outcome

Timeframe: Upon completion of study, up to 56 days

4 meter gait speed will be reported in meters per second

Outcome measures

Outcome measures
Measure	Multimodal Physical Therapy n=15 Participants Multimodal physical therapy sessions three times a week, for four weeks, lasting one hour. Consist of limb strengthening exercises, endurance training, and balance/coordination drills. multimodal physical therapy: Consist of limb strengthening exercises, endurance training, and balance/coordination drills. These exercises and training maneuvers may involve the use of handheld weights, nautilus weight equipment, elastic exercise bands, stationary exercise machines (recumbent exercise cycles, hand ergometer cycles), or treadmills. If the subject is fit enough, Tai Chi may be added to as a training method to help improve your balance and strength. In addition, the subject will be asked to wear an accelerometer on their wrist	Usual Care n=17 Participants Subjects will receive the standard therapy program provided by University Specialty Hospital therapy services. To compliment the physical therapy regimen, an optimized nutritional program will be administered according accepted guidelines.
Functional Assessment: 4 Meter Gait Speed	0.13 m/s Standard Deviation .16	0.07 m/s Standard Deviation .20

PRIMARY outcome

Timeframe: Upon completion of study, up to 56 days

6 minute walk distance will be reported in feet

Outcome measures

Outcome measures
Measure	Multimodal Physical Therapy n=15 Participants Multimodal physical therapy sessions three times a week, for four weeks, lasting one hour. Consist of limb strengthening exercises, endurance training, and balance/coordination drills. multimodal physical therapy: Consist of limb strengthening exercises, endurance training, and balance/coordination drills. These exercises and training maneuvers may involve the use of handheld weights, nautilus weight equipment, elastic exercise bands, stationary exercise machines (recumbent exercise cycles, hand ergometer cycles), or treadmills. If the subject is fit enough, Tai Chi may be added to as a training method to help improve your balance and strength. In addition, the subject will be asked to wear an accelerometer on their wrist	Usual Care n=17 Participants Subjects will receive the standard therapy program provided by University Specialty Hospital therapy services. To compliment the physical therapy regimen, an optimized nutritional program will be administered according accepted guidelines.
Functional Assessment: 6 Minute Walk Distance	40.6 feet Standard Deviation 65.1	19.9 feet Standard Deviation 54.2

SECONDARY outcome

Timeframe: Upon completion of study, up to 56 days

Proportion of patients weaned from mechanical ventilation expressed in percent of total in group

Outcome measures

Outcome measures
Measure	Multimodal Physical Therapy n=15 Participants Multimodal physical therapy sessions three times a week, for four weeks, lasting one hour. Consist of limb strengthening exercises, endurance training, and balance/coordination drills. multimodal physical therapy: Consist of limb strengthening exercises, endurance training, and balance/coordination drills. These exercises and training maneuvers may involve the use of handheld weights, nautilus weight equipment, elastic exercise bands, stationary exercise machines (recumbent exercise cycles, hand ergometer cycles), or treadmills. If the subject is fit enough, Tai Chi may be added to as a training method to help improve your balance and strength. In addition, the subject will be asked to wear an accelerometer on their wrist	Usual Care n=17 Participants Subjects will receive the standard therapy program provided by University Specialty Hospital therapy services. To compliment the physical therapy regimen, an optimized nutritional program will be administered according accepted guidelines.
Percent of Patients Weaned From Mechanical Ventilation	13 Participants	7 Participants

SECONDARY outcome

Timeframe: Upon completion of study, up to 56 days

Proportion of patients discharged home as a percentage of all patients in group

Outcome measures

Outcome measures
Measure	Multimodal Physical Therapy n=15 Participants Multimodal physical therapy sessions three times a week, for four weeks, lasting one hour. Consist of limb strengthening exercises, endurance training, and balance/coordination drills. multimodal physical therapy: Consist of limb strengthening exercises, endurance training, and balance/coordination drills. These exercises and training maneuvers may involve the use of handheld weights, nautilus weight equipment, elastic exercise bands, stationary exercise machines (recumbent exercise cycles, hand ergometer cycles), or treadmills. If the subject is fit enough, Tai Chi may be added to as a training method to help improve your balance and strength. In addition, the subject will be asked to wear an accelerometer on their wrist	Usual Care n=17 Participants Subjects will receive the standard therapy program provided by University Specialty Hospital therapy services. To compliment the physical therapy regimen, an optimized nutritional program will be administered according accepted guidelines.
Percent of Patients Discharged Home	8 Participants	2 Participants

Adverse Events

Multimodal Physical Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Avelino C. Verceles, M.D., M.S.

University of Maryland, Baltimore

Phone: 4103288141

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place