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The purpose of this pilot study is to investigate the potential role of training frequency on locomotor outcomes following high-intensity gait training and provision of a home walking program.
This study will utilize a 2 arm randomized trial to investigate potential differences in locomotor and community outcomes following 18 visits of high-intensity gait training provided over 6 weeks (high frequency) or 12 weeks (low frequency). Following confirmation of eligibility and baseline testing, individuals will be randomized to either high or low frequency of training and complete subsequent testing at 6 weeks, 12 weeks, and 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High frequency | Experimental | Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 6 weeks |
|
| Low frequency | Active Comparator | Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high-intensity gait training | Other | Individuals will perform up to 40 minutes of walking practice during 60 minute sessions while targeting heart rates of at least 70% heart rate reserve. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walk test | Individuals will be asked to "cover as much ground as possible" over 6 mins. Heart rate will additionally be measured during this assessment (distance in m) | After 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Peak treadmill speed | Individuals will participate in a walking-based graded exercise test. While harnessed for safety, a motorized treadmill will be initially set to 0.1 m/s and increased by 0.1 m/s each minute until the test is terminated due: 1) requests to stop, 2) unable to keep up with the treadmill and/or loses their balance, 3) absolute exercise test termination criteria provided by ACSM. The highest speed that the individual can walk for a minute at is the peak treadmill speed. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Gait Assessment | 10 item assessment of dynamic balance. Example tasks include walking with head turns, with eyes closed, and walking backwards. | After 12 weeks |
| 30 second Sit to Stand Test | Participants will be asked to rise from a chair without using their arms and then return to sitting as many times as possible in 30 seconds. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher Henderson, PhD | Contact | 317-329-2353 | henderce@iu.edu | |
| Thomas G Hornby, PhD | Contact | 317-329-2353 | tghornby@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Thomas G Hornby, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Hospital of Indiana | Recruiting | Indianapolis | Indiana | 46254 | United States |
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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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| Physical activity coaching | Behavioral | Individuals will receive feedback on the minutes of walking activity performed on non-training days and provided coaching strategies to increase this metric. |
|
| After 12 weeks |
| After 12 weeks |
| Activity-Specific Balance Confidence (ABC) Scale | This questionnaire asks individuals to rate their balance-confidence from 0 (no confidence) to 100 (completely confident) during a variety of 16 commonly performed tasks such as walking around a house or getting into a car. | After 12 weeks |
| Oxygen Consumption | Oxygen consumption will be measured via a portable metabolic cart (K5; COSMED) during the previously described graded exercise test. Participant will wear a snug fitting mask that covers their mouth and nose, but does not affect the amount or quality of air that they breathe. The mask will be connected to a small backpack that collects information on the rate of breathing and oxygen consumed. | After 12 weeks |
| Medical Outcomes Survey Short-Form 36 (SF-36) | This 36-question survey asks individuals about how their current health may limit their ability to perform typical physical and social activities. | After 12 weeks |
| Steps per Day | Participants will wear a research-grade pedometer (StepWatch; Modus Health) during waking hours for ~1-2 weeks before beginning the training protocol, during the intervention period, and after completing training protocol to quantify home and community mobility. Participants will also be asked to document their daily minutes walked for exercise, number of walking bouts, where they performed the activity, and subjectively how hard they were working while walking for exercise. | After 12 weeks |
| Gait speed | This is an assessment of overground walking speed measured across a distance of ~20 feet and will be conducted at both self-selected (instructions: "walk at your usual, comfortable pace") and fastest (instructions: "walk as fast as you safely can") walking speeds on a pressure sensitive mat (speed in m/s; Zeno Walkway). | After 12 weeks |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |