Clinical trial NCT02835313: Promoting Recovery Optimization With WALKing Exercise After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Christiana Care Health Services
name: Indiana University
First posted: 2016-07-18
Enrollment: 250
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Steps Per Day
timeFrame: Change from Baseline to 3 months (Post)
measure: Steps Per Day
timeFrame: Change from 3 months (Post) to 6 months
measure: Steps Per Day
timeFrame: Change from 3 months (Post) to 12 months
Secondary outcomes:
measure: Six-minute Walk Test Distance
timeFrame: Change from Baseline to 3 months (Post)
measure: Six-minute Walk Test Distance
timeFrame: Change from 3 months (Post) to 6 months
measure: Six-minute Walk Test Distance
timeFrame: Change from 3 months (Post) to 12 months
measure: Self-selected Gait Speed
timeFrame: Change from Baseline to 3 months (Post)
measure: Self-selected Gait Speed
timeFrame: Change from 3 months (Post) to 6 months
measure: Self-selected Gait Speed
timeFrame: Change from 3 months (Post) to 12 months
measure: Oxygen Consumption
timeFrame: Change from Baseline to 3 months (Post)
measure: Oxygen Consumption
timeFrame: Change from 3 months (Post) to 6 months
measure: Oxygen Consumption
timeFrame: Change from 3 months (Post) to 12 months
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Darcy Reisman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.