Promoting Recovery Optimization With WALKing Exercise After Stroke (PROWALKS)

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: FAST+SAM; Behavioral: FAST alone; Behavioral: SAM alone

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19712
      • University of Delaware

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FAST+SAM; Subjects participate in fast walking training in combination with a step activity monitoring program	Behavioral: FAST+SAM; Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks
Active Comparator: FAST alone; Subjects participate in fast walking training	Behavioral: FAST alone; Subjects participate in fast walking training 3x/week for 12 weeks.
Active Comparator: SAM alone; Subjects participate in a step activity monitoring program	Behavioral: SAM alone; Subjects participate in a step activity monitoring program 3x/week for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Steps Per Day	average change in steps per day between two time points, measured over at least a 3-day period for each time point	Change from Baseline to 3 months (Post)
Steps Per Day	average change in steps per day between two time points, measured over at least a 3-day period for each time point	Change from 3 months (Post) to 6 months
Steps Per Day	average change in steps per day between two time points, measured over at least a 3-day period for each time point	Change from 3 months (Post) to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute Walk Test Distance	change between two time points in endurance (measured by distance attained on the 6 minute walk test)	Change from Baseline to 3 months (Post)
Six-minute Walk Test Distance	change between two time points in endurance (measured by distance attained on the 6 minute walk test)	Change from 3 months (Post) to 6 months
Six-minute Walk Test Distance	change between two time points in endurance (measured by distance attained on the 6 minute walk test)	Change from 3 months (Post) to 12 months
Self-selected Gait Speed	change between two time points in average self-selected speed on the 10m walk test	Change from Baseline to 3 months (Post)
Self-selected Gait Speed	change between two time points in average self-selected speed on the 10m walk test	Change from 3 months (Post) to 6 months
Self-selected Gait Speed	change between two time points in average self-selected speed on the 10m walk test	Change from 3 months (Post) to 12 months
Oxygen Consumption	change between two time points in average oxygen consumption at ventilatory threshold	Change from Baseline to 3 months (Post)
Oxygen Consumption	change between two time points in average oxygen consumption at ventilatory threshold	Change from 3 months (Post) to 6 months
Oxygen Consumption	change between two time points in average oxygen consumption at ventilatory threshold	Change from 3 months (Post) to 12 months

Collaborators and Investigators

• Sponsor: University of Delaware
• Collaborators: University of Pennsylvania; Christiana Care Health Services; Indiana University
• Investigators: Principal Investigator: Darcy Reisman, PT, PhD, University of Delaware

Publications and helpful links

General Publications

• Andreasen SC, Wright TR, Crenshaw JR, Reisman DS, Knarr BA. Relationships of Linear and Non-linear Measurements of Post-stroke Walking Activity and Their Relationship to Weather. Front Sports Act Living. 2020 Nov 3;2:551542. doi: 10.3389/fspor.2020.551542. eCollection 2020.
• Wright H, Wright T, Pohlig RT, Kasner SE, Raser-Schramm J, Reisman D. Protocol for promoting recovery optimization of walking activity in stroke (PROWALKS): a randomized controlled trial. BMC Neurol. 2018 Apr 12;18(1):39. doi: 10.1186/s12883-018-1044-1.

Study record dates

Study Major Dates

• Study Start: July 18, 2016
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 15, 2016
• First Posted (Estimated): July 18, 2016

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: NIH 1R01HD086362-01A1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be deposited in the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) repository.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No