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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD093694 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Delaware | OTHER |
| University of Kansas Medical Center | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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The objective of this study is to determine the optimal training intensity and the minimum training duration needed to maximize immediate improvements in walking capacity in chronic stroke. A single-blind, phase II, 3-site randomized controlled trial has been planned. Fifty persons >6 months post stroke will randomize to either moderate-intensity aerobic locomotor training or high-intensity interval locomotor training; each for 45 minutes, 3x/week for up to 36 total sessions over approximately 12 weeks. Clinical measures of walking function, aerobic fitness, daily walking activity and quality of life will be assessed at baseline (PRE) and after 4, 8 and 12 weeks of training (POST-4WK, POST-8WK, POST-12WK).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate-Intensity Aerobic Training | Active Comparator |
| |
| High-Intensity Interval Training | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate-Intensity Aerobic Training | Behavioral | Overground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +/- 5% heart rate reserve, progressing up to 55 +/- 5% heart rate reserve. |
| Measure | Description | Time Frame |
|---|---|---|
| Six-Minute Walk Test Distance | Total distance walked in 6 minutes in meters | Change Six-Minute Walk Test Distance from Baseline to 4 Weeks |
| Six-Minute Walk Test Distance | Total distance walked in 6 minutes in meters | Change Six-Minute Walk Test Distance from Baseline to 8 Weeks |
| Six-Minute Walk Test Distance | Total distance walked in 6 minutes in meters | Change Six-Minute Walk Test Distance from Baseline to 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Comfortable Gait Speed | From 10-meter walk test, in meters per second | Change from Baseline to 4 Weeks |
| Comfortable Gait Speed | From 10-meter walk test, in meters per second |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Capacity | Time to exhaustion during treadmill graded exercise test, recorded in minutes | Change from Baseline to 4 Weeks |
| Exercise Capacity | Time to exhaustion during treadmill graded exercise test, recorded in minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierce Boyne, DPT, PhD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Delaware | Newark | Delaware | 19713 | United States | ||
| University of Kansas Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36822187 | Result | Boyne P, Billinger SA, Reisman DS, Awosika OO, Buckley S, Burson J, Carl D, DeLange M, Doren S, Earnest M, Gerson M, Henry M, Horning A, Khoury JC, Kissela BM, Laughlin A, McCartney K, McQuaid T, Miller A, Moores A, Palmer JA, Sucharew H, Thompson ED, Wagner E, Ward J, Wasik EP, Whitaker AA, Wright H, Dunning K. Optimal Intensity and Duration of Walking Rehabilitation in Patients With Chronic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2023 Apr 1;80(4):342-351. doi: 10.1001/jamaneurol.2023.0033. | |
| 42064927 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| 424597 | Individual Participant Data Set | View IPD |
We deposited the final, de-identified dataset and data documentation into the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) archive (URL below)
Data are available now and should remain available indefinitely.
Established by the repository
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| ID | Title | Description |
|---|---|---|
| FG000 | High-Intensity Interval Training | High-Intensity Interval Training: Overground and treadmill walking with 30 second bursts at maximum speed alternated with 30-60 second passive recovery periods. Intended to achieve a target average heart rate above 60% heart rate reserve. |
| FG001 | Moderate-Intensity Aerobic Training | Moderate-Intensity Aerobic Training: Overground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +/- 5% heart rate reserve, progressing up to 55 +/- 5% heart rate reserve. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High-Intensity Interval Training | High-Intensity Interval Training: Overground and treadmill walking with 30 second bursts at maximum speed alternated with 30-60 second passive recovery periods. Intended to achieve a target average heart rate above 60% heart rate reserve. |
| BG001 | Moderate-Intensity Aerobic Training |
| 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 | Six-Minute Walk Test Distance | Total distance walked in 6 minutes in meters | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | meters | Change Six-Minute Walk Test Distance from Baseline to 4 Weeks |
|
Duration of participant enrollment post-randomization, which was approximately 4 months for participants who completed the study
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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 | High-Intensity Interval Training | High-Intensity Interval Training: Overground and treadmill walking with 30 second bursts at maximum speed alternated with 30-60 second passive recovery periods. Intended to achieve a target average heart rate above 60% heart rate reserve. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| seizure | Nervous system disorders | Systematic Assessment | seizure leading to temporary hospitalization, judged to be unrelated to study procedures |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain/soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Pain/soreness related to treatment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pierce Boyne | University of Cincinnati | 5135587499 | Pierce.Boyne@uc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 16, 2021 | Jul 13, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2020 | Apr 13, 2021 | 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 |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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| NIH |
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| High-Intensity Interval Training | Behavioral | Overground and treadmill walking with 30 second bursts at maximum speed alternated with 30-60 second passive recovery periods. Intended to achieve a target average heart rate above 60% heart rate reserve. |
|
| Change from Baseline to 8 Weeks |
| Comfortable Gait Speed | From 10-meter walk test, in meters per second | Change from Baseline to 12 Weeks |
| Fast Gait Speed | From 10-meter walk test, in meters per second | Change from Baseline to 4 Weeks |
| Fast Gait Speed | From 10-meter walk test, in meters per second | Change from Baseline to 8 Weeks |
| Fast Gait Speed | From 10-meter walk test, in meters per second | Change from Baseline to 12 Weeks |
| Aerobic Fitness | Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute | Change from Baseline to 4 Weeks |
| Aerobic Fitness | Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute | Change from Baseline to 8 Weeks |
| Aerobic Fitness | Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute | Change from Baseline to 12 Weeks |
| PROMIS-Fatigue Scale | The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale is an 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5, where higher scores indicate greater fatigue. A total raw score is calculated by summing the scores for each item. The raw score is then translated into a T-score based on normative data. The T-score is a standardized score with a mean of 50 and a standard deviation of 10 for the U.S. general population, so a T-score of 60 (for example) would represent one SD higher (worse) fatigue than the average American. | Change from Baseline to 4 Weeks |
| PROMIS-Fatigue Scale | The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale is an 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5, where higher scores indicate greater fatigue. A total raw score is calculated by summing the scores for each item. The raw score is then translated into a T-score based on normative data. The T-score is a standardized score with a mean of 50 and a standard deviation of 10 for the U.S. general population, so a T-score of 60 (for example) would represent one SD higher (worse) fatigue than the average American. | Change from Baseline to 8 Weeks |
| PROMIS-Fatigue Scale | The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale is an 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5, where higher scores indicate greater fatigue. A total raw score is calculated by summing the scores for each item. The raw score is then translated into a T-score based on normative data. The T-score is a standardized score with a mean of 50 and a standard deviation of 10 for the U.S. general population, so a T-score of 60 (for example) would represent one SD higher (worse) fatigue than the average American. | Change from Baseline to 12 Weeks |
| Change from Baseline to 8 Weeks |
| Exercise Capacity | Time to exhaustion during treadmill graded exercise test, recorded in minutes | Change from Baseline to 12 Weeks |
| Peak Oxygen Consumption Rate | Peak oxygen consumption rate during treadmill graded exercise test, in milliliters per kilogram body mass per minute | Change from Baseline to 4 Weeks |
| Peak Oxygen Consumption Rate | Peak oxygen consumption rate during treadmill graded exercise test, in milliliters per kilogram body mass per minute | Change from Baseline to 8 Weeks |
| Peak Oxygen Consumption Rate | Peak oxygen consumption rate during treadmill graded exercise test, in milliliters per kilogram body mass per minute | Change from Baseline to 12 Weeks |
| Metabolic Cost of Gait | Oxygen consumption rate relative to speed during treadmill graded exercise test, in milliliters per kilogram body mass per meter | Change from Baseline to 4 Weeks |
| Metabolic Cost of Gait | Oxygen consumption rate relative to speed during treadmill graded exercise test, in milliliters per kilogram body mass per meter | Change from Baseline to 8 Weeks |
| Metabolic Cost of Gait | Oxygen consumption rate relative to speed during treadmill graded exercise test, in milliliters per kilogram body mass per meter | Change from Baseline to 12 Weeks |
| EuroQol 5D-5L (EQ-5D-5L) | A 5-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total misery score was calculated by summing the scores for each item (min 5, max 25). | Change from Baseline to 4 Weeks |
| EuroQol 5D-5L (EQ-5D-5L) | A 5-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total misery score was calculated by summing the scores for each item (min 5, max 25). | Change from Baseline to 8 Weeks |
| EuroQol 5D-5L (EQ-5D-5L) | A 5-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total misery score was calculated by summing the scores for each item (min 5, max 25). | Change from Baseline to 12 Weeks |
| Activities-specific Balance Confidence Scale | A 16-item questionnaire that asks participants to rate their balance confidence during everyday tasks, as a percentage from 0-100%, where higher scores indicate greater balance self-efficacy. A total score from 0-100 is calculated by averaging the scores for each item. | Change from Baseline to 4 Weeks |
| Activities-specific Balance Confidence Scale | A 16-item questionnaire that asks participants to rate their balance confidence during everyday tasks, as a percentage from 0-100%, where higher scores indicate greater balance self-efficacy. A total score from 0-100 is calculated by averaging the scores for each item. | Change from Baseline to 8 Weeks |
| Activities-specific Balance Confidence Scale | A 16-item questionnaire that asks participants to rate their balance confidence during everyday tasks, as a percentage from 0-100%, where higher scores indicate greater balance self-efficacy. A total score from 0-100 is calculated by averaging the scores for each item. | Change from Baseline to 12 Weeks |
| Daily Walking Activity | Mean daily step count recorded with activity monitor, recorded as steps per day | Change from Baseline to 4 Weeks |
| Daily Walking Activity | Mean daily step count recorded with activity monitor, recorded as steps per day | Change from Baseline to 8 Weeks |
| Daily Walking Activity | Mean daily step count recorded with activity monitor, recorded as steps per day | Change from Baseline to 12 Weeks |
| Kansas City |
| Kansas |
| 66160 |
| United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Derived |
| Pressler D, Schwab-Farrell SM, Awosika OO, Reisman DS, Billinger SA, Riley MA, Boyne P. Predicting Musculoskeletal Adverse Events During Moderate- to High-Intensity Walking Training in Chronic Stroke. medRxiv [Preprint]. 2026 Apr 18:2026.04.16.26351040. doi: 10.64898/2026.04.16.26351040. |
| 40025665 | Derived | Boyne P, Miller A, Schwab-Farrell SM, Sucharew H, Carl D, Billinger SA, Reisman DS. Training Parameters and Adaptations That Mediate Walking Capacity Gains from High-Intensity Gait Training Poststroke. Med Sci Sports Exerc. 2025 Jul 1;57(7):1285-1296. doi: 10.1249/MSS.0000000000003691. Epub 2025 Mar 3. |
| 34271979 | Derived | Miller A, Reisman DS, Billinger SA, Dunning K, Doren S, Ward J, Wright H, Wagner E, Carl D, Gerson M, Awosika O, Khoury J, Kissela B, Boyne P. Moderate-intensity exercise versus high-intensity interval training to recover walking post-stroke: protocol for a randomized controlled trial. Trials. 2021 Jul 16;22(1):457. doi: 10.1186/s13063-021-05419-x. |
Moderate-Intensity Aerobic Training: Overground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +/- 5% heart rate reserve, progressing up to 55 +/- 5% heart rate reserve. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Stroke chronicity | Time interval from stroke onset to consent date | Mean | Standard Deviation | years |
|
| Self-selected gait speed | Mean | Standard Deviation | meters/second |
|
| 6-minute walk test distance | Mean | Standard Deviation | meters |
|
| OG001 |
| Moderate-Intensity Aerobic Training |
Moderate-Intensity Aerobic Training: Overground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +/- 5% heart rate reserve, progressing up to 55 +/- 5% heart rate reserve. |
|
|
| Primary | Six-Minute Walk Test Distance | Total distance walked in 6 minutes in meters | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | meters | Change Six-Minute Walk Test Distance from Baseline to 8 Weeks |
|
|
|
| Primary | Six-Minute Walk Test Distance | Total distance walked in 6 minutes in meters | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | meters | Change Six-Minute Walk Test Distance from Baseline to 12 Weeks |
|
|
|
| Secondary | Comfortable Gait Speed | From 10-meter walk test, in meters per second | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | m/s | Change from Baseline to 4 Weeks |
|
|
|
| Secondary | Comfortable Gait Speed | From 10-meter walk test, in meters per second | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | m/s | Change from Baseline to 8 Weeks |
|
|
|
| Secondary | Comfortable Gait Speed | From 10-meter walk test, in meters per second | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | m/s | Change from Baseline to 12 Weeks |
|
|
|
| Secondary | Fast Gait Speed | From 10-meter walk test, in meters per second | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | m/s | Change from Baseline to 4 Weeks |
|
|
|
| Secondary | Fast Gait Speed | From 10-meter walk test, in meters per second | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | m/s | Change from Baseline to 8 Weeks |
|
|
|
| Secondary | Fast Gait Speed | From 10-meter walk test, in meters per second | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | m/s | Change from Baseline to 12 Weeks |
|
|
|
| Secondary | Aerobic Fitness | Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | mL/kg/min | Change from Baseline to 4 Weeks |
|
|
|
| Secondary | Aerobic Fitness | Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | mL/kg/min | Change from Baseline to 8 Weeks |
|
|
|
| Secondary | Aerobic Fitness | Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | mL/kg/min | Change from Baseline to 12 Weeks |
|
|
|
| Secondary | PROMIS-Fatigue Scale | The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale is an 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5, where higher scores indicate greater fatigue. A total raw score is calculated by summing the scores for each item. The raw score is then translated into a T-score based on normative data. The T-score is a standardized score with a mean of 50 and a standard deviation of 10 for the U.S. general population, so a T-score of 60 (for example) would represent one SD higher (worse) fatigue than the average American. | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | T score | Change from Baseline to 4 Weeks |
|
|
|
| Secondary | PROMIS-Fatigue Scale | The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale is an 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5, where higher scores indicate greater fatigue. A total raw score is calculated by summing the scores for each item. The raw score is then translated into a T-score based on normative data. The T-score is a standardized score with a mean of 50 and a standard deviation of 10 for the U.S. general population, so a T-score of 60 (for example) would represent one SD higher (worse) fatigue than the average American. | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | T score | Change from Baseline to 8 Weeks |
|
|
|
| Secondary | PROMIS-Fatigue Scale | The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale is an 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5, where higher scores indicate greater fatigue. A total raw score is calculated by summing the scores for each item. The raw score is then translated into a T-score based on normative data. The T-score is a standardized score with a mean of 50 and a standard deviation of 10 for the U.S. general population, so a T-score of 60 (for example) would represent one SD higher (worse) fatigue than the average American. | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | T score | Change from Baseline to 12 Weeks |
|
|
|
| Other Pre-specified | Exercise Capacity | Time to exhaustion during treadmill graded exercise test, recorded in minutes | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Change from Baseline to 4 Weeks |
|
|
|
| Other Pre-specified | Exercise Capacity | Time to exhaustion during treadmill graded exercise test, recorded in minutes | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Change from Baseline to 8 Weeks |
|
|
|
| Other Pre-specified | Exercise Capacity | Time to exhaustion during treadmill graded exercise test, recorded in minutes | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Change from Baseline to 12 Weeks |
|
|
|
| Other Pre-specified | Peak Oxygen Consumption Rate | Peak oxygen consumption rate during treadmill graded exercise test, in milliliters per kilogram body mass per minute | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | mL/kg/min | Change from Baseline to 4 Weeks |
|
|
|
| Other Pre-specified | Peak Oxygen Consumption Rate | Peak oxygen consumption rate during treadmill graded exercise test, in milliliters per kilogram body mass per minute | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | mL/kg/min | Change from Baseline to 8 Weeks |
|
|
|
| Other Pre-specified | Peak Oxygen Consumption Rate | Peak oxygen consumption rate during treadmill graded exercise test, in milliliters per kilogram body mass per minute | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | mL/kg/min | Change from Baseline to 12 Weeks |
|
|
|
| Other Pre-specified | Metabolic Cost of Gait | Oxygen consumption rate relative to speed during treadmill graded exercise test, in milliliters per kilogram body mass per meter | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | mL/kg/m | Change from Baseline to 4 Weeks |
|
|
|
| Other Pre-specified | Metabolic Cost of Gait | Oxygen consumption rate relative to speed during treadmill graded exercise test, in milliliters per kilogram body mass per meter | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | mL/kg/m | Change from Baseline to 8 Weeks |
|
|
|
| Other Pre-specified | Metabolic Cost of Gait | Oxygen consumption rate relative to speed during treadmill graded exercise test, in milliliters per kilogram body mass per meter | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | mL/kg/m | Change from Baseline to 12 Weeks |
|
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| Other Pre-specified | EuroQol 5D-5L (EQ-5D-5L) | A 5-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total misery score was calculated by summing the scores for each item (min 5, max 25). | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | score | Change from Baseline to 4 Weeks |
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| Other Pre-specified | EuroQol 5D-5L (EQ-5D-5L) | A 5-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total misery score was calculated by summing the scores for each item (min 5, max 25). | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | score | Change from Baseline to 8 Weeks |
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| Other Pre-specified | EuroQol 5D-5L (EQ-5D-5L) | A 5-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total misery score was calculated by summing the scores for each item (min 5, max 25). | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | score | Change from Baseline to 12 Weeks |
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| Other Pre-specified | Activities-specific Balance Confidence Scale | A 16-item questionnaire that asks participants to rate their balance confidence during everyday tasks, as a percentage from 0-100%, where higher scores indicate greater balance self-efficacy. A total score from 0-100 is calculated by averaging the scores for each item. | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | score | Change from Baseline to 4 Weeks |
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| Other Pre-specified | Activities-specific Balance Confidence Scale | A 16-item questionnaire that asks participants to rate their balance confidence during everyday tasks, as a percentage from 0-100%, where higher scores indicate greater balance self-efficacy. A total score from 0-100 is calculated by averaging the scores for each item. | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | score | Change from Baseline to 8 Weeks |
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| Other Pre-specified | Activities-specific Balance Confidence Scale | A 16-item questionnaire that asks participants to rate their balance confidence during everyday tasks, as a percentage from 0-100%, where higher scores indicate greater balance self-efficacy. A total score from 0-100 is calculated by averaging the scores for each item. | Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | score | Change from Baseline to 12 Weeks |
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| Other Pre-specified | Daily Walking Activity | Mean daily step count recorded with activity monitor, recorded as steps per day | Results are from a modified intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Four participants (2 in the HIT group and 2 in the MAT group) had to be excluded because they had no valid days of step data collected outside of study visits. Other missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | steps/day | Change from Baseline to 4 Weeks |
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| Other Pre-specified | Daily Walking Activity | Mean daily step count recorded with activity monitor, recorded as steps per day | Results are from a modified intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Four participants (2 in the HIT group and 2 in the MAT group) had to be excluded because they had no valid days of step data collected outside of study visits. Other missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | steps/day | Change from Baseline to 8 Weeks |
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| Other Pre-specified | Daily Walking Activity | Mean daily step count recorded with activity monitor, recorded as steps per day | Results are from a modified intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Four participants (2 in the HIT group and 2 in the MAT group) had to be excluded because they had no valid days of step data collected outside of study visits. Other missing data were handled with the maximum likelihood method. | Posted | Least Squares Mean | 95% Confidence Interval | steps/day | Change from Baseline to 12 Weeks |
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| 0 |
| 27 |
| 1 |
| 27 |
| 13 |
| 27 |
| EG001 | Moderate-Intensity Aerobic Training | Moderate-Intensity Aerobic Training: Overground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +/- 5% heart rate reserve, progressing up to 55 +/- 5% heart rate reserve. | 0 | 28 | 3 | 28 | 10 | 28 |
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| fall with fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | fall with hip fracture, judged to be unrelated to study procedures |
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| delirium | Nervous system disorders | Systematic Assessment | delirium leading to temporary hospitalization, judged to be unrelated to study procedures |
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| stroke | Nervous system disorders | Systematic Assessment | recurrent stroke, judged to be unrelated to study procedures |
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| Fatigue | General disorders | Systematic Assessment | Fatigue related to treatment |
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| Lightheadedness | General disorders | Systematic Assessment | lightheadedness related to treatment |
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| Fall | General disorders | Systematic Assessment | Fall without injury related to treatment |
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Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |