High vs low-frequency of high-intensity training in chronic stroke: a pilot randomized trial
T. George Hornby
Primary Investigator
Brief description of study
Detailed description of study
- Study participation will last approximately 6.5 months and involve participation in four total evaluations and up to 18 total training visits.
- Training sessions will occur at the Rehabilitation Hospital of Indiana and consist of walking practice in different environments (e.g., treadmill, stairs, overground) while targeting heart rates typical of aerobic exercise and generally perceived as ‘hard’ to ‘very hard’ by the individual.
- Participants will be asked to track their minutes of daily walking exercise and work with research staff to identify weekly goals for walking exercise with an aim to increase this over the course of the study.
- For about a week at each evaluation and throughout the intervention on non-training days, participants will wear a step counter (StepWatch) to measure the number of steps they take each day.
- Participants will be randomized (i.e., coin flip) to receive up to 18 one-hour training sessions over either 6 weeks (i.e., ~3x/week) or 12 weeks (i.e., ~1.5x/week).
- Clinical evaluations will be conducted before starting training, at approximately 6 weeks, 12 weeks, and 24 weeks.
- Potential risks with participation in this project are similar to participation in conventional physical therapy or exercise and include increased spasticity, muscle soreness, fatigue, or shortness of breath.
- Participants are compensated up to $340 to help offset travel and transportation costs if they participate in all testing and training sessions.
- While we cannot guarantee results, the goal of this project is to improve walking and balance for individuals that participate.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Stroke
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Age: Between 18 Years - 85 Years
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Gender: All
Inclusion Criteria:
• Unilateral deficits following stroke > 6 months prior; however individuals > 4 months post-stroke are eligible for consenting, but final eligibility and potential enrollment will not occur until > 6 months
• Age 18-85
• Weight < 350 pounds
• Able to follow 3-step commands
• Able to ambulate with self-selected gait speeds between 0.10-1.0 m/s without physical assistance, but with below knee bracing and/or assistive device as needed
• Lower extremity Fugl-Meyer < 34
• Medical clearance to participate
Exclusion Criteria:
• Evidence of cerebellar ataxia
• Uncontrolled cardiopulmonary or metabolic disease that limits exercise participation, active heterotopic ossification, recurrent history of lower extremity fractures, previous orthopedic or other peripheral or central neurologic injury that may impair locomotor activities such that, in the judgement of the PI, could compromise the safety of the participant, limit the ability to complete the study, or compromise the objectives of the study.
• Currently participating in other physical therapy
• >50 units of Botox in the lower extremity OR in the lower extremity, but above the knee if the participant wears an ankle-foot-orthosis (AFO) within the past three months
