The Effects of Early Mobilization and Endurance Training for Patients With Prolonged Mechanical Ventilator
Condition: Mechanical Ventilation Complication
Study type: Interventional

Summary: 
      The primary hypothesis is that prolonged mechanically ventilated adults who participate in an
      early mobilization and endurance exercise training protocol, have an improved pulmonary
      outcome and functional capacity and more functionally independent at hospital discharge
      compared to patients receiving the usual physiotherapy care. Further, the investigators
      expect improvements in weaning rate from mechanical ventilator, less time on mechanical
      ventilation, a shorter length of stay in the respiratory care center and the hospital, and a
      higher quality of life at 6 months after hospital discharge compared to patients receiving
      usual care. The investigators will conduct a prospective, single-center, allocation concealed
      and assessor-blinded randomised controlled trial with superiority design and 6-month
      follow-up. The study is being conducted in the interdisciplinary respiratory care center of
      Taichung Tzu Chi Hospital, Taiwan. To be eligible to participate in the study patients must
      be aged 18 to 75, be expected to stay on mechanical ventilator for at least 21 days, which
      reflects a prolonged stay at mechanical ventilator. Standard care (control group)
      Participants randomised to the control group will receive usual physiotherapy and respiratory
      care center standard care, which includes weaning protocols and bed exercise program based on
      previous publications. In this procedure, physiotherapy and mobilization will start after
      medical prescription. Treatments are based on the therapist's assessment and are accordingly
      individually tailored. Sessions will usually take place once daily from Monday to Friday. The
      participants randomised to the experimental group will receive a standardised exercise
      program involving early mobilization and endurance training.

      The endurance training will be conducted with grading exercise level. In the course of
      endurance training, The participants will be prompted verbally for at least 10 min. The aim
      during all mobilizations will be to involve the participants as actively as possible to
      promote independence.
    

Detailed description: 
      The primary hypothesis is that prolonged mechanically ventilated adults who participate in an
      early mobilization and endurance exercise training protocol, have an improved pulmonary
      outcome and functional capacity and are, therefore, more functionally independent at hospital
      discharge compared to patients receiving the usual physiotherapy care. Secondary hypotheses
      are that this early training protocol is as feasible and as safe as standard therapy
      protocol. Further, The investigators expect improvements in weaning rate from mechanical
      ventilator, less time on mechanical ventilation, a shorter length of stay in the respiratory
      care center and the hospital, and a higher quality of life at 6 months after hospital
      discharge compared to participants receiving usual care.

      Methods and design The investigators will conduct a prospective, single-center, allocation
      concealed and assessor-blinded randomised controlled trial with superiority design and
      6-month follow-up. The study has been approved by the Ethics Committee of Taichung Tzu Chi
      Hospital, Buddhist Tzu Chi Medical Foundation, Taiwan. This trial is conducted according to
      Taiwan law and Good Clinical Practice (GCP) guidelines.

      Study population The study is being conducted in the interdisciplinary respiratory care
      center of Taichung Tzu Chi Hospital, Taiwan. To be eligible to participate in the study
      patients must be aged 18 or older, be expected to stay on mechanical ventilator for at least
      21 days, which reflects a prolonged stay at mechanical ventilator. The participants with
      prior muscle weakness, such as a preexisting neurological or neuromuscular disease with
      functional deficits or a prolonged bedridden for at least 2 months prior to the respiratory
      care center admission, are excluded from the study. Further exclusion criteria are
      contraindications to cycling (mainly fractures or recent surgical procedures to the lower
      limbs, acute thrombosis, preexisting open wounds, extracorporeal membrane oxygenation (ECMO)
      and body weight of more than 150 kg), patients who are already enrolled in another
      intervention study, patients receiving palliative care, patients with a diagnosis on
      admission that excludes the possibility of walking at hospital discharge (for example,
      paraplegia) and lastly patients who do not understand either traditional Chinese and
      Taiwanese language. Standard care (control group) Participants randomised to the control
      group will receive usual physiotherapy and respiratory care center standard care, which
      includes weaning protocols and bed exercise program based on previous publications. Current
      physiotherapy practice consists of positioning, respiratory therapy, passive range of
      movement exercises for nonresponsive participants or active exercises if arousable, and early
      mobilization. In order to start as early as possible, physiotherapists screen participants
      regularly focusing on prevention and treatment of functional and pulmonary impairment.
      However, subject to the internal procedure, physiotherapy and mobilization will start after
      medical prescription. Treatments are based on the therapist's assessment and are accordingly
      individually tailored. Sessions will usually take place once daily from Monday to Friday and,
      if deemed necessary (e.g. severe weakness, intensive rehabilitation and weaning period,
      retained airway secretion or atelectasis in extubated participants), this includes treatment
      at the weekend.

      Study intervention (experimental group) Participants randomised to the experimental group
      will receive a standardised exercise program involving early mobilization and endurance
      training. The clinician in charge will decide before study inclusion, whether there are any
      contraindications to include the patient, and during the study, if at any time the treatment
      should be stopped, e.g. in case of an adverse event (decreased SaO2). Therefore, the
      intervention will be started as soon as it is deemed safe by the treating respiratory care
      center team and will occur from Monday to Friday and, if deemed necessary, at the weekend.
      Throughout all activities, progression will be increased successively, depending on an
      individual's tolerance and stability. If needed, the physiotherapist will split the delivery
      of the exercise program into one or more sessions.

      The number of treatments, its content and duration will be noted for both the control and
      experimental group. The endurance training will be conducted with grading exercise level. In
      the course of endurance training, patient's participation will be prompted verbally. After
      achieving patient's active participation in sitting on the bed, the goal will be to train for
      at least 20 min. If this is accomplished, exercise level and training period increased until
      a maximum of 7 on modified RPE. Tolerance and stability will be judged by the responsible
      physiotherapist according to patient's modified perceived level of exertion (modified RPE
      Scale). If a participant is able to perform the exercises correctly, he will be given a
      tutorial with pictures in order to train independently with nurses or family members. If
      unable to perform the exercises, the physiotherapist will use tactile facilitation or passive
      range of movement for all joints and their possible directions. If the previous exercises are
      well-tolerated, bed mobility and sitting upright in bed will be started. If these are
      well-tolerated and no contraindications as per medical prescription exist, the treatment will
      be further advanced to mobilizing participants to the bedside. There, balance exercises will
      be performed or, if needed, support will be provided by the physiotherapist or various
      assistive equipment. After being able to sit for at least 10 min on the side of the bed,
      regardless of whether support is needed, participants will be moved into a chair with an
      individually adapted transfer according to the individual's resources. The aim during all
      mobilizations will be to involve the patient as actively as possible to promote independence.
      While sitting, functional tasks and activities of daily living will be performed and
      gradually increased to standing and walking exercises.
    

Intervention name(s): Early Mobilization and endurance training; Usual Care
Intervention type(s): Other; Other
Intervention description(s): The early mobilization and endurance training will be conducted with grading exercise level. In the course of endurance training. After achieving patient's active participation in sitting on the bed, the goal will be to train for at least 20 min. If this is accomplished, exercise level and training period increased until a maximum of 7 on modified RPE. If these are well-tolerated and no contraindications as per medical prescription exist, the treatment will be further advanced to mobilizing participants to the bedside. After being able to sit for at least 10 min on the side of the bed, regardless of whether support is needed, participants will be moved into a chair with an individually adapted transfer according to the individual's resources.While sitting, functional tasks and activities of daily living will be performed and gradually increased to standing and walking exercises.; The weaning protocols, bed exercise, positioning, respiratory therapy, and early mobilization.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mechanical Ventilators; Weaning; Exercise therapy