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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| Christiana Care Health Services | OTHER |
| Indiana University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAST+SAM | Experimental | Subjects participate in fast walking training in combination with a step activity monitoring program |
|
| FAST alone | Active Comparator | Subjects participate in fast walking training |
|
| SAM alone | Active Comparator | Subjects participate in a step activity monitoring program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAST alone | Behavioral | Subjects participate in fast walking training 3x/week for 12 weeks. |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darcy Reisman, PT, PhD | University of Delaware | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Delaware | Newark | Delaware | 19712 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40637166 | Derived | Thompson ED, McCartney KM, Pohlig RT, Hornby TG, Kasner SE, Raser-Schramm J, Henderson CE, Wright H, Wright T, Reisman DS. Maintenance of Improvements in Walking Activity in Individuals with Chronic Stroke: Follow-Up From the PROWALKS Randomized Controlled Trial. Neurorehabil Neural Repair. 2025 Oct;39(10):779-788. doi: 10.1177/15459683251352493. Epub 2025 Jul 10. | |
| 39606374 |
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De-identified data will be deposited in the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) repository.
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| ID | Title | Description |
|---|---|---|
| FG000 | FAST+SAM | Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks |
| FG001 | FAST Alone | Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks. |
| FG002 | SAM Alone | Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FAST+SAM | Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks |
| BG001 | FAST Alone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | steps per day | Change from Baseline to 3 months (Post) |
|
Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months.
Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FAST+SAM | Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recurrent Stroke (Randomization-Post) | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Falls (Randomization-Post) | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Darcy Reisman, PT, PhD, FAPTA | University of Delaware | 302-831-0508 | dreisman@udel.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 12, 2023 | May 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012436 | S-Adenosylmethionine |
| ID | Term |
|---|---|
| D008715 | Methionine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| 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 |
|
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 |
| McCartney KM, Pohlig RT, Miller A, Thompson ED, Reisman D. Matching Clinical Profiles with Interventions to Optimize Daily Stepping in People with Stroke. medRxiv [Preprint]. 2024 Nov 15:2024.11.14.24317334. doi: 10.1101/2024.11.14.24317334. |
| 38134254 | Derived | Thompson ED, Pohlig RT, McCartney KM, Hornby TG, Kasner SE, Raser-Schramm J, Miller AE, Henderson CE, Wright H, Wright T, Reisman DS. Increasing Activity After Stroke: A Randomized Controlled Trial of High-Intensity Walking and Step Activity Intervention. Stroke. 2024 Jan;55(1):5-13. doi: 10.1161/STROKEAHA.123.044596. Epub 2023 Dec 22. |
| 37609269 | Derived | Thompson ED, Pohlig RT, McCartney KM, Hornby TG, Kasner SE, Raser-Schramm J, Miller AE, Henderson CE, Wright H, Wright T, Reisman DS. Increasing activity after stroke: a randomized controlled trial of highintensity walking and step activity intervention. medRxiv [Preprint]. 2023 Aug 9:2023.03.11.23287111. doi: 10.1101/2023.03.11.23287111. |
| 33345115 | Derived | 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. |
| 29649992 | Derived | 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. |
Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks. |
| BG002 | SAM Alone | Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | In the study, participants self-identified their race in non-exclusive categories (e.g., they were permitted to choose "more than one race" as well as other categories). This is the format in which the data are published. Due to the constraints of this database, race data have been converted to mutually exclusive categories (e.g., an individual identifying as "more than one race" was not classified here as being in any other race category, even if the participant themselves chose other race categories.) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Time since stroke | Mean | Standard Deviation | months |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Side of hemiparesis | Count of Participants | Participants |
|
| Ambulatory assistive device use | Count of Participants | Participants |
|
| Lower extremity orthotic use | Count of Participants | Participants |
|
| Steps per day | Mean | Standard Deviation | steps/day |
|
| Six-minute walk test distance | Mean | Standard Deviation | meters |
|
| Self-selected gait speed | Mean | Standard Deviation | meters/sec |
|
| VO2 at ventilatory threshold | Mean | Standard Deviation | mL/kg per min |
|
| OG002 |
| SAM Alone |
Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks. |
|
|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | steps per day | Change from 3 months (Post) to 6 months |
|
|
|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | steps per day | Change from 3 months (Post) to 12 months |
|
|
|
| Secondary | Six-minute Walk Test Distance | change between two time points in endurance (measured by distance attained on the 6 minute walk test) | Posted | Mean | 95% Confidence Interval | meters | Change from Baseline to 3 months (Post) |
|
|
|
| Secondary | Six-minute Walk Test Distance | change between two time points in endurance (measured by distance attained on the 6 minute walk test) | Posted | Mean | 95% Confidence Interval | meters | Change from 3 months (Post) to 6 months |
|
|
|
| Secondary | Six-minute Walk Test Distance | change between two time points in endurance (measured by distance attained on the 6 minute walk test) | Posted | Mean | 95% Confidence Interval | meters | Change from 3 months (Post) to 12 months |
|
|
|
| Secondary | Self-selected Gait Speed | change between two time points in average self-selected speed on the 10m walk test | Posted | Mean | 95% Confidence Interval | meters/sec | Change from Baseline to 3 months (Post) |
|
|
|
| Secondary | Self-selected Gait Speed | change between two time points in average self-selected speed on the 10m walk test | Posted | Mean | 95% Confidence Interval | meters/sec | Change from 3 months (Post) to 6 months |
|
|
|
| Secondary | Self-selected Gait Speed | change between two time points in average self-selected speed on the 10m walk test | Posted | Mean | 95% Confidence Interval | meters/sec | Change from 3 months (Post) to 12 months |
|
|
|
| Secondary | Oxygen Consumption | change between two time points in average oxygen consumption at ventilatory threshold | Posted | Mean | 95% Confidence Interval | mL/kg/min | Change from Baseline to 3 months (Post) |
|
|
|
| Secondary | Oxygen Consumption | change between two time points in average oxygen consumption at ventilatory threshold | Posted | Mean | 95% Confidence Interval | mL/kg/min | Change from 3 months (Post) to 6 months |
|
|
|
| Secondary | Oxygen Consumption | change between two time points in average oxygen consumption at ventilatory threshold | Posted | Mean | 95% Confidence Interval | mL/kg/min | Change from 3 months (Post) to 12 months |
|
|
|
| 0 |
| 80 |
| 14 |
| 80 |
| 25 |
| 80 |
| EG001 | FAST Alone | Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks. | 1 | 89 | 9 | 89 | 38 | 89 |
| EG002 | SAM Alone | Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks. | 0 | 81 | 3 | 81 | 19 | 81 |
| Myocardial Infarction (Randomization-Post) | Cardiac disorders | Systematic Assessment |
|
| Fracture (Randomization-Post) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hospitalization (Randomization-Post) | General disorders | Systematic Assessment |
|
| Death (Randomization-Post) | General disorders | Systematic Assessment |
|
| Significant incapacity to perform ADLs for >48 hrs (Randomization-Post) | General disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
| Recurrent Stroke (Post-12 months) | Nervous system disorders | Systematic Assessment |
|
| Myocardial Infarction (Post-12 months) | Cardiac disorders | Systematic Assessment |
|
| Fracture (Post-12 months) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hospitalization (Post-12 months) | General disorders | Systematic Assessment |
|
| Death (Post-12 months) | General disorders | Systematic Assessment |
|
| Significant incapacity to perform ADLs for >48 hrs (Post-12 months) | General disorders | Systematic Assessment |
|
| Other (Post-12 months) | General disorders | Systematic Assessment |
|
| Dyspnea (Randomization-Post) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Open sore/blister/cut (Randomization-Post) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Muscle pain/soreness lasting >48 hrs (Randomization-Post) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness/fainting (Randomization-Post) | General disorders | Systematic Assessment |
|
| Diaphoresis (Randomization-Post) | General disorders | Systematic Assessment |
|
| COVID-19 illness (Randomization-Post) | General disorders | Systematic Assessment |
|
| Other (Randomization-Post) | General disorders | Systematic Assessment |
|
| Falls (Post-12 months) | General disorders | Systematic Assessment |
|
| Dyspnea (Post-12 months) | General disorders | Systematic Assessment |
|
| Open sore/blister/cut (Post-12 months) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Muscle pain/soreness lasting >48 hrs (Post-12 months) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness/fainting (Post-12 months) | General disorders | Systematic Assessment |
|
| Diaphoresis (Post-12 months) | General disorders | Systematic Assessment |
|
| COVID-19 illness (Post-12 months) | General disorders | Systematic Assessment |
|
| Other (Post-12 months) | General disorders | Systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000241 |
| Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |