Skip to main content
OpenTrials
Completed

NCT Number: NCT02835313

Promoting Recovery Optimization With WALKing Exercise After Stroke

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19712, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 21-85
  • Chronic stroke (>6 months post stroke)
  • Able to walk at self-selected speed without assistance from another person (assistive devices are allowed)
  • Self-selected walking speed >0.3 m/s and <1.0 m/s
  • Average steps/day <8,000
  • Resting heart rate between 40-100 beats per minute
  • Resting blood pressure between 90/60 to 170/90.

Exclusion criteria

  • Evidence of cerebellar stroke
  • Other potentially disabling neurologic conditions in addition to stroke
  • Lower limb Botulinum toxin injection <4 months earlier
  • Current participation in physical therapy
  • Inability to walk outside the home prior to the stroke
  • Coronary artery bypass graft, stent placement or myocardial infarction within past 3 months
  • Musculoskeletal pain that limits activity
  • Inability to communicate with investigators
  • score >1 on question 1b and >0 on question 1c on the NIH Stroke Scale.

Treatment and study plan

FAST alone

Behavioral

Subjects participate in fast walking training 3x/week for 12 weeks.

FAST+SAM

Behavioral

Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks

SAM alone

Behavioral

Subjects participate in a step activity monitoring program 3x/week for 12 weeks

Primary outcomes

  1. Steps Per Day

    Time frame: Change from Baseline to 3 months (Post)

    average change in steps per day between two time points, measured over at least a 3-day period for each time point

  2. Steps Per Day

    Time frame: Change from 3 months (Post) to 6 months

    average change in steps per day between two time points, measured over at least a 3-day period for each time point

  3. Steps Per Day

    Time frame: Change from 3 months (Post) to 12 months

    average change in steps per day between two time points, measured over at least a 3-day period for each time point

Secondary outcomes

  1. Six-minute Walk Test Distance

    Time frame: Change from Baseline to 3 months (Post)

    change between two time points in endurance (measured by distance attained on the 6 minute walk test)

  2. Six-minute Walk Test Distance

    Time frame: Change from 3 months (Post) to 6 months

    change between two time points in endurance (measured by distance attained on the 6 minute walk test)

  3. Six-minute Walk Test Distance

    Time frame: Change from 3 months (Post) to 12 months

    change between two time points in endurance (measured by distance attained on the 6 minute walk test)

  4. Self-selected Gait Speed

    Time frame: Change from Baseline to 3 months (Post)

    change between two time points in average self-selected speed on the 10m walk test

  5. Self-selected Gait Speed

    Time frame: Change from 3 months (Post) to 6 months

    change between two time points in average self-selected speed on the 10m walk test

  6. Self-selected Gait Speed

    Time frame: Change from 3 months (Post) to 12 months

    change between two time points in average self-selected speed on the 10m walk test

  7. Oxygen Consumption

    Time frame: Change from Baseline to 3 months (Post)

    change between two time points in average oxygen consumption at ventilatory threshold

  8. Oxygen Consumption

    Time frame: Change from 3 months (Post) to 6 months

    change between two time points in average oxygen consumption at ventilatory threshold

  9. Oxygen Consumption

    Time frame: Change from 3 months (Post) to 12 months

    change between two time points in average oxygen consumption at ventilatory threshold

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • Christiana Care Health Services
  • Indiana University
  • University of Pennsylvania

Registry information

Acronym: PROWALKS

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2016
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.