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

NCT00108030 | Completed Phase 2

• 2 other identifiers: NHMRC 301974Australia: NHMRC 301974
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 3

Brief 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. 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. 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. 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. 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. 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.

Conditions

Stroke

Keywords

PBWST training; Strength training; 6-min walking endurance; Cardiovascular fitness; Psychosocial attributes

Outcome Measures

Primary Outcomes (1)

• Distance walked in 6-min

Secondary Outcomes (5)

• 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.

Interventions

Partial Body-weight supported Treadmill Training PROCEDURE

PBWST + Power training PROCEDURE

"Usual" physiotherapy care PROCEDURE

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unstable cardiac disease,
• Known un-repaired aortic or cerebral aneurysm
• Hemorrhagic stroke, symptomatic hernias, symptom limiting peripheral vascular disease,
• End-stage congestive cardiac failure,
• Significant musculotendinous or bony restrictions of either limb,

Sponsors & Collaborators

• University of Sydney: lead

Study Sites (3)

Rehabilitation Research Centre, University of Sydney

Sydney, New South Wales, 2141, Australia

Location

School of Physiotherapy, University of Sydney

Sydney, New South Wales, 2141, Australia

Location

Coorabel Brain Injury Unit, Royal Rehabilitation Centre Sydney

Sydney, New South Wales, Australia

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sharon L Kilbreath, PhD

  University of Sydney

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 12, 2005
• First Posted: April 13, 2005
• Study Start: March 1, 2004
• Study Completion: December 1, 2006
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

AU (3)