Development of a Rehabilitation Strengthening and Mobility Program for Ventilator Dependent Older Patients
Condition: Respiration, Artificial; Critical Illness; Chronic Disease; Exercise Therapy; Rehabilitation; Physical Therapy Modalities
MeSH terms: Critical Illness; Chronic Disease
Study type: Interventional

Summary: 
      As the general population ages and technology advances, many who suffer from catastrophic
      critical illness (i.e. septic shock, respiratory failure, Acute Respiratory Disease Syndrome)
      survive only to find themselves severely physically debilitated and compromised from a
      pulmonary standpoint, requiring assistance from a mechanical ventilator in order to breath.
      Oftentimes, these patients require a long course of physical rehabilitation and ventilator
      support. These patients frequently remain ventilator dependent for greater than 3 weeks, and
      are thus referred to as requiring prolonged mechanical ventilation (PMV).

      Older patients are at significantly higher risk for requiring PMV for reasons that are not
      entirely clear, but which may include physical deconditioning, impaired cardiopulmonary
      physiology, and cognitive or behavioral disturbances.

      The purpose of this study is two fold: 1. to characterize the functional phenotype of
      ventilator dependent, and recently ventilated patients with respect to general strength,
      endurance, balance, and pulmonary functioning and body composition. 2. To pilot test a
      rehabilitation protocol that targets improving this populations disabilities through
      exercises focused on improving strength, endurance, balance, and pulmonary functioning.
    

Detailed description: 
      Screening will occur daily, at which time the subject's medical history and current condition
      will be reviewed. If they qualify informed consent will be obtained and the subject will
      undergo baseline tests of function and health.

      The subject will be asked to perform simple tasks for baseline testing purposes. These
      include timed walking, lifting light weights or elastic exercise bands, assessment of
      handgrip strength, getting up out of a chair, breathing into a machine to test lung function,
      and answering questionnaires. The order of these tests may vary depending upon the subject's
      schedule and availability of equipment. It may be necessary to repeat one or more of the
      tests. Not all tests will be performed on everyone, depending upon one's strength, balance,
      coordination and endurance.

      After the completion of the baseline tests subjects will be randomized into one of two
      groups. One group will receive a multimodal rehabilitation program (MRP) and usual care and
      the other will receive usual care physical therapy.

      If the subject is randomized to the intervention group, he/she will receive special MRP
      sessions three times a week, for up to 8 weeks. Each session will last approximately one
      hour, and will 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. All sessions will
      be supervised by a licensed physical therapist, physical trainer, or certified instructor,
      with a respiratory therapist present, if needed. Sessions will be conducted at the Pulmonary
      Rehabilitation Gymnasium at the University of Maryland, Midtown Campus (MTC) or in the
      subjects room at bedside.

      If the subject is not randomized to the group receiving the MRP, they will receive the
      standard therapy program provided by MTC therapy services. To compliment the physical therapy
      regimen, an optimized nutritional program will be administered according accepted guidelines.

      If the subject misses/does not complete a session the training period will be extended to
      insure completion of the required number of sessions. If the subject is not randomized to the
      group receiving the MRP, they will receive the standard therapy program provided by MTC
      therapy services.

      After two weeks of additional training, or 6 MRP sessions, the subjects will be re-evaluated
      with repeat physical activity testing. The subject will be required to complete activities
      similar to what they performed during your baseline evaluation. Retesting will be conducted
      regardless of which training regimen the subject received (MRP vs. standard physical
      therapy). Subjects will then train for an additional 2 weeks followed by repeat testing.

      The each subject's participation in the study will be completed 1) after eight weeks of
      physical therapy, 2) If the subject has been discharged from the Comprehensive Pulmonary
      Rehabilitation Unit, or MTC, 3) if the subject gets transferred from MTC.

      All procedures will take place at MTC.

      Exercises and maneuvers will include:

        1. Limb strengthening exercises: various exercises will be conducted, both as assessment
           maneuvers, and as therapeutic purposes. These will include 1.lower extremity function
           (get up and go, sit to stand, isometric leg press/extension) 2. upper extremity function
           (modified military press, isometric triceps exercise, seated row, scapular depression).

             1. Isometric leg press/extension: Subjects will be asked to perform leg extension from
                a seated position against a pad attached to a machine that offers resistance. This
                resistance will be adjusted according to the force capability of each participant.
                The leg press maneuver will also be performed from a seated position.

             2. Modified military press: Subjects will be asked to perform this procedure from a
                seated position. A machine offering resistance will be gripped at shoulder level.
                The subject will be asked to extend their arms against the resistance to a straight
                position and then slowly lower the load until they are back in the starting
                position, with arms bent and hands at shoulder level.

             3. Isometric triceps exercise: From a seated position, a subject will be asked to hold
                a dumbell in one hand straight over their head with their back straight. the weight
                will be slowly lowered down behind the subjects neck in an arc with the elbow kept
                stationary. The subject will then press the bar upwards but re-extending their arm,
                thus completing the repetition upon full tricep extension.

             4. Tricep Press Exercise (as tolerated): Using an overhead pulley machine a subject
                will be asked to stand facing the machine holding the resistance bar in front of
                them at chest level with arms in a flexed position, palms facing away from them.
                The subject will then extend their arms in a downward motion, keeping the elbow
                stationary, until their arms are fully extended at the subjects side with palms
                facing backwards.

             5. Chest press: (Using dumbells or press machine as tolerated) The subject will lie on
                a bench or floor with a dumbbell in each hand, knees bent and your feet flat on the
                surface. The dumbells will be positioned shoulder width (in the laying position,
                directly above the shoulders) with arms and wrists straight and palms facing
                towards the subjects feet. To start a the exercise, the subject will lower the
                dumbells (or weight machine) towards their chest until the upper arms are at about
                a 45 degree angle to the body. The weights should lowered to a level approximately
                in line with the subjects chest. To complete the repetition, the subject is
                required to straighten their arms, concentrating on using their chest muscles until
                their arms are straight. The palms should face away from the patient, (or towards
                the patients feet) throughout the entire motion.

             6. Seated row: From a seated position, with their back and legs straight, the subject
                will be required to grasp the handle of the seated row pulley system with arms
                straight. Maintaining straight back and legs, the subject will pull the handle
                towards them, at waist level. The subject should concentrate on using their back
                muscles, rather than just their arms. Once the handle is pulled to the patients
                waist, the subject will slowly allow the handle to return to the starting position
                to complete the repetition.

             7. Scapular depression: (as tolerated) From a seated position keeping their back
                straight with arms and hands to each side, the subject will be asked to clasp the
                seat of the chair and lift their bottom from the seat by straightening your elbows
                and pushing the shoulders down. to complete the repetition, the subject will be
                lower him or herself slowly back to the seated starting position.

           The one repetition maximum (1 RM) will be measured on the same exercise equipment used
           for strengthening exercises at baseline and after the ST program. The 1 RM test is
           defined as the maximal resistance that can be moved through the full range of motion
           with proper form one time. The 1 RM maneuver will be performed for each limb
           strengthening exercise, and will be conducted and supervised by trained and licensed
           physical therapists. Ratings of perceived effort and discomfort will be recorded
           periodically throughout the test. The test will be immediately terminated if a high
           discomfort rating is reached during the test, which is unrelated to normal
           exertion-induced muscle fatigue.

           One-on-one supervision by qualified physical therapists will be used for all training
           sessions. These therapists will be able to demonstrate the proper technique and form for
           all exercise maneuvers. These exercises have been successfully performed in protocols
           completed by over 300 older men and women over the past several years, and are
           well-tolerated by participants. The investigators anticipate that all subjects will not
           be able to tolerate all tests, thus the testing regimen will be tailored to each
           subjects tolerance.

        2. General strength (handgrip): The subject will be asked to perform this maneuver from a
           seated position with their upper arm and forearm at a 90 degree angle. Handgrip strength
           will be assess and recorded as the best of three attempts as measured on a dynamometer.

        3. Maneuvers to assess pulmonary function, which include maximal expiratory pressure and
           maximal inspiratory pressure. All pulmonary function maneuvers are performed routinely
           at the USH pulmonary function laboratory by a trained respiratory therapist.

             1. Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) are
                measurements aid in the evaluating for respiratory muscle weakness. MIP is the
                pressure generated during maximal inspiratory effort measured at the mouth. It is
                usually measured from residual volume (RV) (end of expiration). Inspiratory muscle
                strength is also inversely related to lung volume. Performing the maneuver requires
                the subject to exhale to RV. With tight seal at mouth and nose, inspire (using
                diaphragm) forcefully and sustain for 1-2 seconds.

             2. MEP is pressure generated during maximal expiratory effort measured at the mouth.
                It is measured at total lung capacity (TLC), (full breath). Expiratory muscle
                strength is directly related to lung volume. Performing the maneuver requires the
                subject to inhale to TLC. With tight seal at mouth and nose, expire (using
                diaphragm) forcefully and sustain for 1-2 seconds.

        4. Six minute walk (Aerobic function): The subject will be asked to walk at their own pace
           on a 30 meter course outlined in a corridor at USH. Their total distance walked after
           six minutes will be recorded. During this test the patient will be continuously
           monitored using pulse oximetry, heart rate monitoring and subjective visual scales of
           dyspnea (borg index).

        5. Balance and Gait: The Short Physical Performance Battery (SPPB) is a series of simple
           tests requiring the subject to perform repeated standing and sitting from a chair, stand
           in place with feet placed close to one another forming a narrow base, and to walk 4
           meters. The SPPB has been well validated as a reproducible assessment of balance, gait
           speed and lower extremity strength and endurance, and has been used by the investigators
           in several studies without complication.

        6. Skinfolds / Circumference measures: a tape measure will be used to measure the distance
           around one or more locations on the subjects body (for example: upper arm, thigh, waist,
           hips, chest). In addition, a skinfold caliper (measures skin thickness) will be used to
           assess body fat by gently pinching the skin at the same locations on the subjects body.
    

Intervention name(s): multimodal physical therapy
Intervention type(s): Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Up to 75 patients will be screened with a goal of enrolling 40 for participate in the intervention trial (20 in the multimodal treatment arm and 20 in a group receiving usual care).
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Physical Therapy Modalities; Rehabilitation; Exercise Therapy; Critical Illness; Respiration, Artificial; Chronic Disease