PBWST (Partial Body-Weight Supported Treadmill Training) and Muscle Power Training After Sub-Acute Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2005 by University of Sydney.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sydney
ClinicalTrials.gov Identifier:
NCT00108030
First received: April 12, 2005
Last updated: June 23, 2005
Last verified: April 2005
  Purpose

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.

Condition Intervention Phase
Stroke
Procedure: Partial Body-weight supported Treadmill Training
Procedure: PBWST + Power training
Procedure: "Usual" physiotherapy care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A RCT of Power Training and Treadmill Training to Improve Walking Ability in Sub-Acute Stroke Patients

Further study details as provided by University of Sydney:

Primary Outcome Measures:
  • Distance walked in 6-min

Secondary Outcome Measures:
  • 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.
  • Lower limb muscular strength, power and endurance will be assessed using the pneumatic resistance machines.
  • Cardiorespiratory fitness will be assessed from variables collected during a maximal effort cycle test and a multistage exercise test.
  • 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.

Estimated Enrollment: 102
Study Start Date: March 2004
Estimated Study Completion Date: December 2006
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.
  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First stroke resulting in hemiplegia;
  • Mini-Mental State Exam score > 15;
  • Distance walked in 6-min walk test is less than the lower limit of ‘normal’ according to reference equations for healthy adults (adjusted for gender, age, BMI [Body Mass Index])
  • Score on walking subscale of the Motor Assessment Scale of ≥ 2.

Exclusion Criteria:

  • Unstable cardiac disease,
  • Known un-repaired aortic or cerebral aneurysm
  • Hemorrhagic stroke, symptomatic hernias, symptom limiting peripheral vascular disease,
  • End-stage congestive cardiac failure,
  • Any of the exclusion criteria contraindicating moderate exercise as outlined by American College of Sports Medicine guidelines for cardiac disease rehabilitation or for frail and elderly adults.
  • Significant musculotendinous or bony restrictions of either limb,
  • Any serious chronic disease independently causing significant disability or profound atrophy of the affected limb will comprise further exclusion criteria.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00108030

Contacts
Contact: Sharon L Kilbreath, PhD +61 2 9351 9466 s.kilbreath@fhs.usyd.edu.au

Locations
Australia, New South Wales
School of Physiotherapy, University of Sydney Recruiting
Sydney, New South Wales, Australia, 2141
Contact: Sharon L Kilbreath, PhD    +61 2 9351 9272    s.kilbreath@fhs.usyd.edu.au   
Principal Investigator: Sharon L Kilbreath, PhD         
Sub-Investigator: Maria F Singh, MD         
Sub-Investigator: Brian Zeman, MBBS         
Sub-Investigator: Glen Davis, PhD         
Sub-Investigator: Jack Crosbie, PhD         
Coorabel Brain Injury Unit, Royal Rehabilitation Centre Sydney Recruiting
Sydney, New South Wales, Australia
Contact: Brian Zeman, PhD    +61 2 9808-9353    zemanb@doh.health.nsw.gov.au   
Sub-Investigator: Brian Zeman, MBBS         
Rehabilitation Research Centre, University of Sydney Recruiting
Sydney, New South Wales, Australia, 2141
Contact: Glen M Davis, PhD, FACSM    +61 2 9351 9466    g.davis@fhs.usyd.edu.au   
Sub-Investigator: Glen M Davis, PhD         
Sponsors and Collaborators
University of Sydney
Investigators
Principal Investigator: Sharon L Kilbreath, PhD University of Sydney
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00108030     History of Changes
Other Study ID Numbers: NHMRC 301974, Australia: NHMRC 301974
Study First Received: April 12, 2005
Last Updated: June 23, 2005
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by University of Sydney:
PBWST training
Strength training
6-min walking endurance
Cardiovascular fitness
Psychosocial attributes

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 18, 2014