Promoting Recovery Optimization With WALKing Exercise After Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: FAST; Behavioral: SAM; Behavioral: FAST+SAM

• Registration Number: NCT02835313
• Lead Sponsor: University of Delaware

Brief Summary

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.

Study Timeline

• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-15
• Study Start: 2016-07-18
• Study First Posted: 2016-07-18
• Primary Completion: 2023-01
• Study Completion: 2023-12
• Status Verified: 2024-03
• Results First Submitted: 2024-07-05
• Results First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Results First Posted: 2024-10-28
• Last Update Posted: 2024-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
FAST	FAST	Subjects participate in fast walking training
SAM	SAM	Subjects participate in a step activity monitoring program
FAST+SAM	FAST+SAM	Subjects participate in fast walking training in combination with a step activity monitoring program

Primary Outcome Measures

Name	Time	Method
Steps Per Day	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 Outcome Measures

Name	Time	Method
Six-minute Walk Test Distance	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)
Self-selected Gait Speed	Change from 3 months (Post) to 12 months	change between two time points in average self-selected speed on the 10m walk test
Oxygen Consumption	Change from 3 months (Post) to 12 months	change between two time points in average oxygen consumption at ventilatory threshold

Trial Locations

Locations (1)

University of Delaware; 🇺🇸 Newark, Delaware, United States