Promoting Recovery Optimization With WALKing Exercise After Stroke "PROWALKS"

Recruiting

Phase 2/3 Results N/A

Trial Description

Stroke survivors, as a group, are extremely inactive and this has serious consequences for them, including an increased risk of a second stroke and developing other diseases. This study investigates a novel intervention designed to improve everyday activity after stroke by combining walking training to improve walking capacity with a program to encourage more daily walking.

Detailed Description

As a group, stroke survivors are more physically inactive than even the most sedentary older adults. Lack of physical activity has serious consequences in persons with stroke, including an increased risk of recurrent stroke, developing other diseases and mortality. Current rehabilitation interventions do little to improve real-world walking activity after stroke, suggesting that simply improving walking capacity is not sufficient for improving daily physical activity after stroke. Rather, the investigator's hypothesize that the combination of a fast walking intervention that improves walking capacity, with a step activity monitoring program that facilitates translation of gains from the clinic to the "real-world", would generate greater improvements in real world walking activity than with either intervention alone. Data from the investigator's lab provides support for this hypothesis; however, it suggests that the greater efficacy of combining the 2 interventions depends on a participant's initial walking activity. Thus, the investigator's do not expect that one intervention will be superior to the others for all participants, but rather that the combined intervention will be superior for those with low levels of baseline walking activity, speed and endurance. The specific objective of this study is to test whether and for whom combining fast walking training with a step activity monitoring program (FAST+SAM) is superior in improving real-world walking activity compared to fast walking training alone (FAST) or a step activity monitoring and feedback program alone (SAM) in those with chronic stroke. Using a randomized controlled experimental design, 225 chronic (> 6 months) stroke survivors, will complete 12 weeks of fast walking training (FAST), a step activity monitoring program (SAM) or a fast walking training + step activity monitoring program (FAST+SAM). Moderation of specific intervention outcomes by baseline characteristics will be evaluated to determine for whom the interventions are effective.

Conditions

Interventions

  • Rehabilitation Other
    Intervention Desc: Subjects participate in rehabilitation including fast walking training (FAST), a step activity monitoring program (SAM) or a fast walking training + step activity monitoring program (FAST+SAM) 3x/week for 12 weeks.
    ARM 1: Kind: Experimental
    Label: FAST+SAM
    Description: Subjects participate in fast walking training in combination with a step activity monitoring program
    ARM 2: Kind: Experimental
    Label: FAST
    Description: Subjects participate in fast walking training
    ARM 3: Kind: Experimental
    Label: SAM
    Description: Subjects participate in a step activity monitoring program
  • FAST Behavioral
    Intervention Desc: Subjects participate in fast walking training 3x/week for 12 weeks.
    ARM 1: Kind: Experimental
    Label: FAST
    Description: Subjects participate in fast walking training
  • FAST+SAM Behavioral
    Intervention Desc: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks
    ARM 1: Kind: Experimental
    Label: FAST+SAM
    Description: Subjects participate in fast walking training in combination with a step activity monitoring program
  • SAM Behavioral
    Intervention Desc: Subjects participate in a step activity monitoring program 3x/week for 12 weeks
    ARM 1: Kind: Experimental
    Label: SAM
    Description: Subjects participate in a step activity monitoring program

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Intervention: Factorial Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Steps per day Change in steps per day from pre-intervention to 12 months later No
Secondary walking speed as measured by the 10 meter walk test Change in walking speed from pre-intervention to 12 months later No
Secondary endurance as measured by the 6 minute walk test Change in endurance from pre-intervention to 12 months later No
Secondary oxygen consumption Change in oxygen consumption from pre-intervention to 12 months later No

Sponsors