PBWST (Partial Body-Weight Supported Treadmill Training) and Muscle Power Training After Sub-acute Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The specific aim of this project is to improve walking ability in persons following stroke
      using 'treadmill training plus power training'. This modality addresses the two major
      impairments followings stroke: weakness and incoordination, as well as loss of fitness.
      Importantly, this training will be presented at higher intensity and greater volume than is
      currently received. Furthermore, to ensure that persons continue to maintain the level of
      improvement from an intensive exercise program, we will also implement a behavioral change
      for long-term maintenance of exercise behavior in a less supervised environment. A randomized
      controlled clinical trial will be conducted in 102 sub-acute stroke patients to ascertain the
      efficacy of this approach to improving walking ability.

      Hypotheses:

        1. Walking endurance will be increased to a greater degree in a patient group receiving
           treadmill plus muscle power training compared with a treadmill training only group, or
           'usual care' group.

        2. Gait stability, muscle function, aerobic fitness and balance will improve more in a
           group receiving treadmill plus muscle power training, than either those in treadmill
           training or usual care patient groups.

        3. Habitual activity levels will be higher in the group receiving treadmill plus muscle
           power training compared with a treadmill training only group or 'usual care' group.

        4. The change in 6-minute walk distance will be positively related to changes in muscle
           power, strength and endurance, aerobic fitness, gait mechanics, and balance.

        5. Baseline depression and low self-efficacy will be associated with less robust
           adaptations to all types of training and lower rates of long-term compliance to the
           exercise prescription in the experimental groups.
    

Detailed description: 
      To determine treatment efficacy, a single blinded, randomized controlled trial will be
      conducted. One hundred and two subjects will be randomly allocated to one of three groups
      comprising: (i) "Treadmill training + Power training" (TT+POWER), (ii) "Treadmill training"
      (TT), or (iii) "Usual Care" (USUAL). Those in the TT+POWER and TT will also receive 'usual
      care'. Subjects will be recruited within a week or two following their stroke, at which time
      they would be expected to be medically stable. Subjects in the training groups will attend
      training for 10 weeks, 3 times per week. Following the ten-week training program, subjects
      will be given a home-based training package to follow for 6 months.

      Interventions:

      Treadmill Training: The emphasis of the weight-supported treadmill training program will be
      initially to emphasize walking alignment. The amount of support will be reduced as quickly as
      possible to attain full weight-bearing on the motorized treadmill. Once a subject has
      attained full weight-bearing with correct segmental alignment, the emphasis will be on
      improving aerobic fitness whilst maintaining proper walking alignment.

      Treadmill Training + Power Training: Subjects will undertake 30 min treadmill training, as
      described above, followed by 30 min of power training using pneumatic resistance equipment
      (Keiser Sports Health, Inc., Fresco, CA, USA) (leg press, knee extension and flexion, hip
      abduction, and plantarflexion). Standard principles governing frequency, volume, duration,
      and intensity of exercise known to provide maximal adaptation in both healthy and frail
      adults will be followed. Legs will be trained unilaterally.

      Home-based program: Following 10 weeks of training, subjects will be given a home-based
      training program to continue indefinitely. Subjects in the TT+Power group will be given
      weights with instructions on use, and a walking program whereas those in the TT group will be
      given a walking program. To encourage compliance with the program, subjects will be
      telephoned weekly, and visited monthly. Subjects also will be requested to fill in a weekly
      log sheet detailing their exercise sessions and other physical activities, which is mailed to
      the trainer for feedback each week.

      Outcomes: Outcomes will be measured prior to commencement of training, after 10 weeks
      training, and then after 6-months home based exercise.

      The Primary outcome is the distance walked in 6-min. This test was selected because walking
      distance is an important criterion for community ambulation. It is related to functional
      impairment as well as strength of the lower limb muscles and aerobic fitness, avoids the
      problem of gait velocity being relevant only for short-distance ambulation, and is a robust
      measurement.

      Secondary Outcomes:

        1. Other walking variables and balance variables: The total number of steps taken during
           waking hours, using an accelerometer with a large capacity data logger. Temporal and
           spatial variables associated with walking, as well as balance will be assessed.

        2. Lower limb muscular strength, power and endurance will be assessed using the pneumatic
           resistance machines.

        3. Cardiorespiratory fitness will be assessed from variables collected during a maximal
           effort cycle test and a multistage exercise test.

        4. Scales and questionnaires will provide an assessment of changes in the subject's
           psychological and functional states. Scales include a stroke impact scale, a
           self-efficacy scale, health related qualify of life questionnaire, and a geriatric
           depression scale.
    

Intervention name(s): Partial Body-weight supported Treadmill Training; PBWST + Power training; "Usual" physiotherapy care
Intervention type(s): Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single
Primary purpose: Treatment
Keywords: PBWST training; Strength training; 6-min walking endurance; Cardiovascular fitness; Psychosocial attributes