Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Residual neurological deficits from stroke lead to gait inefficiencies, resulting in an extremely high energy cost of movement and contributing to overall disability and lower quality of life. Therefore, interventions targeting movement economy should be developed for those in the chronic phase of stroke recovery. This study is designed to compare the effect of two distinctly different exercise paradigms (a higher-intensity treadmill training program and a lower-intensity group exercise program) on economy of movement during over-ground walking and activities of daily living, as well as the extent to which gains in muscular strength, muscular endurance, and balance predict changes in movement economy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: High-Intensity Program | Other | High-intensity treadmill-based exercise |
|
| Arm 2: Low-Intensity Program | Other | Low-intensity lifestyle intervention (group exercise) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-intensity Treadmill Exercise | Behavioral | High-intensity treadmill walking program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Economy of Gait | Over-ground gait economy measured using a portable metabolic monitoring system, K4b2 during a 6 minute walk, with subjects walking at their comfortable self-selected walking speed while open circuit spirometry collects break-by-break data. The K4b2 consists of a small battery pack and portable gas analyser (weighing less than 1 kg) that participants wear on their chest. Attached to the portable system is a flexible rubber facemask with flowmeter used for breath-by-breath analysis. The mean rate of oxygen consumption (VO2) will be calculated based on the final 3 minutes of a 6-minute walk under steady state oxygen consumption conditions. A 6 minute walk is a distance most representative of community-based ambulatory capacity and is a sensitive outcome measure in exercise studies in chronic stroke subjects. The higher the VO2 used during the 6 minute walk, represents a less efficient economy of gait. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Muscular Strength | Strength measured by torque of isokinetic maximal concentric knee extensor volitional contractions of paretic and non-paretic leg at multiple angular velocities (30, 90, and 120°/sec). The higher the number the higher the muscular strength. Also performed on resistance equipment for both the Leg Press and Leg Extension. The higher the number the stronger a person is. | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Regular structured aerobic exercise (> 2x week).
Alcohol consumption > 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report.
Clinical history of
Untreated major depression as documented by a Center for Epidemiological Studies-Depression score of >16 and confirmed by clinical interview.
Pregnancy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alyssa D Stookey, PhD MS | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40079581 | Derived | Liu X, Zhang Y, Li F, Liu L, Du J, Song WQ. Test-retest reliability and practice effects of shape trail test in stroke patients. Top Stroke Rehabil. 2025 Oct;32(7):779-788. doi: 10.1080/10749357.2025.2457282. Epub 2025 Mar 13. | |
| 34242857 | Derived | Stookey AD, Macko RF, Ivey FM, Katzel LI. Evaluating Test-Retest Reliability of Fatigability in Chronic Stroke. J Stroke Cerebrovasc Dis. 2021 Sep;30(9):105895. doi: 10.1016/j.jstrokecerebrovasdis.2021.105895. Epub 2021 Jul 7. |
Not provided
Not provided
Not provided
Hemiparetic stroke survivors (>6 months) with residual hemiparetic gait in women/men aged 30-85 years who completed all therapy were recruited. They had to have adequate language and neurocognitive function, give adequate informed consent, able to rise from a chair unaided, and able to walk 10 meters without human assistance.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: High-Intensity Program | High-intensity treadmill-based exercise High-intensity Treadmill Exercise: High-intensity treadmill walking program |
| FG001 | Arm 2: Low-Intensity Program | Low-intensity lifestyle intervention (group exercise) Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: High-Intensity Program | High-intensity treadmill-based exercise High-intensity Treadmill Exercise: High-intensity treadmill walking program |
| BG001 | Arm 2: Low-Intensity Program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Economy of Gait | Over-ground gait economy measured using a portable metabolic monitoring system, K4b2 during a 6 minute walk, with subjects walking at their comfortable self-selected walking speed while open circuit spirometry collects break-by-break data. The K4b2 consists of a small battery pack and portable gas analyser (weighing less than 1 kg) that participants wear on their chest. Attached to the portable system is a flexible rubber facemask with flowmeter used for breath-by-breath analysis. The mean rate of oxygen consumption (VO2) will be calculated based on the final 3 minutes of a 6-minute walk under steady state oxygen consumption conditions. A 6 minute walk is a distance most representative of community-based ambulatory capacity and is a sensitive outcome measure in exercise studies in chronic stroke subjects. The higher the VO2 used during the 6 minute walk, represents a less efficient economy of gait. | Posted | Mean | Standard Deviation | ml/kg/min | 3 months |
|
Adverse event information was obtained for participants for the duration of their time in this study (0-3months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: High-Intensity Program | High-intensity treadmill-based exercise High-intensity Treadmill Exercise: High-intensity treadmill walking program |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophagitis/Upper Gastrointestinal Bleed | Gastrointestinal disorders | Non-systematic Assessment | Participant hospitalized for esophagitis/Upper Gastrointestinal Bleed. Proton Pump inhibitor added to medication; eventually cleared by Primary Care Physician to resume participation in the study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | General disorders | Non-systematic Assessment | All adverse events other than the one serious event reported were participant falls (expected in this population). No serious injuries reported from falls and all falls were due to losing balance (not fainting or loss of consciousness). |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Specilist | Baltimore VA Medical Center (VAHMCS) | 410-605-7156 | alyssa.stookey@va.gov |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Low-intensity Lifestyle Intervention | Behavioral | A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength. |
|
| Muscular Endurance | Muscular endurance performed on Leg Press and assessed by a force transducer, while seated. The longer the amount of time participant can maintain a force the better their muscular endurance. | 3 months |
| Balance | Dynamic Gait Index - another measure related to balance and general function. It includes items of walking while changing speed, turning the head, pivot turning, walking over and around obstacles, and stair climbing. This index ranges from 0 - 24, with 24 representing a high level of balance and general function (the higher the score the better the balance). | 3 months |
Low-intensity lifestyle intervention (group exercise)
Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
High-intensity treadmill-based exercise High-intensity Treadmill Exercise: High-intensity treadmill walking program |
| OG001 | Arm 2: Low-Intensity Program | Low-intensity lifestyle intervention (group exercise) Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength. |
|
|
| Secondary | Muscular Strength | Strength measured by torque of isokinetic maximal concentric knee extensor volitional contractions of paretic and non-paretic leg at multiple angular velocities (30, 90, and 120°/sec). The higher the number the higher the muscular strength. Also performed on resistance equipment for both the Leg Press and Leg Extension. The higher the number the stronger a person is. | Posted | Mean | Standard Deviation | newtons (N) | 3 months |
|
|
|
| Secondary | Muscular Endurance | Muscular endurance performed on Leg Press and assessed by a force transducer, while seated. The longer the amount of time participant can maintain a force the better their muscular endurance. | Posted | Mean | Standard Deviation | seconds | 3 months |
|
|
|
| Secondary | Balance | Dynamic Gait Index - another measure related to balance and general function. It includes items of walking while changing speed, turning the head, pivot turning, walking over and around obstacles, and stair climbing. This index ranges from 0 - 24, with 24 representing a high level of balance and general function (the higher the score the better the balance). | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| 1 |
| 11 |
| 6 |
| 11 |
| EG001 | Arm 2: Low-Intensity Program | Low-intensity lifestyle intervention (group exercise) Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength. | 0 | 9 | 8 | 9 |
|
|
Not provided
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
| Leg Press Non-Paretic Leg |
|
| Leg Press Paretic Leg |
|