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Multimodal Exercise Training Poststroke

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ClinicalTrials.gov Identifier: NCT03174392
Recruitment Status : Active, not recruiting
First Posted : June 2, 2017
Last Update Posted : August 1, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Christopher Hurt, University of Alabama at Birmingham

Brief Summary:
Individuals poststroke with gait and balance impairment are typically less active and have low levels of physical fitness. Improving fitness level while also improving gait and balance is very important. Maximizing the exercise training benefit requires the appropriate level of effort is achieved. Traditional exercise programs scale aerobic demand by increasing the walking speed or the slope of the treadmill surface. This may be difficult for individuals who experience decreased balance at faster speeds or on sloped surfaces and require the use of handrails to safely walk under these conditions. These exercise programs show limited improvement in walking ability after training. This project will test a novel approach, resistance-based treadmill walking, for maximizing improvements in fitness and ability to walk by individuals poststroke. The investigators previous research has shown that backward directed resistive force applied to the pelvis while walking is well tolerated by individuals poststroke. Further, these forces can be used to effectively scale aerobic demand while walking in a controlled manner. With traditional treadmill training approaches handrail support is utilized to ensure safety. However, handrail support externally stabilizes the individual reducing training improvements in walking capacity and balance. For this pilot investigation a group that aerobically trains using a standard exercise treadmill training paradigm will be compared to a group that experiences progressive backward directed resistive forces applied to an individuals' pelvis while they walk at comfortable walking speeds without the aid of handrails. Individuals will wear a fall harness that provides no external stabilization but prevents falls to the treadmill surface. This approach has the potential benefit of allowing individuals poststroke to meaningfully practice walking at safe speeds but against resistance thereby improving walking economy, dynamic balance, and walking speed. The proposed project is necessary to gather preliminary data for a much larger training study that has the potential to change the clinical approach for improving gait economy, balance, and walking speed for individuals poststroke.

Condition or disease Intervention/treatment Phase
Exercise Stroke Other: Resistance Based Training Other: Speed Based Training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Exercise Training in a Novel Training Environment Compared to Increased Treadmill Speed During Walking With Individuals Poststroke
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Resistance based training study:
Each training session will begin by determining the treadmill walking speed that an individual will train. The speed of the treadmill will be incrementally increased stepwise and individuals will affirm which speed feels the most comfortable to walk. Thus, the training speed of individuals will not necessarily be fixed over the 8-week study. Heart rate will be monitored and resistive force will be applied stepwise until the heart rate reaches at least 60% heart rate reserve. Individuals will be encouraged to walk at least five minutes and then be allowed to rest. Achieved heart rate reserve and time the spent training at 60-80% heart rate reserve will be quantified for each session. Subjective measures of effort will also be sampled using the Borg Scale.
Other: Resistance Based Training
Resistance based training study: Each training session will begin by determining the treadmill walking speed that an individual will train. The speed of the treadmill will be incrementally increased stepwise and individuals will affirm which speed feels the most comfortable to walk. Thus, the training speed of individuals will not necessarily be fixed over the 8-week study. Heart rate will be monitored and resistive force will be applied stepwise until the heart rate reaches at least 60% heart rate reserve. Individuals will be encouraged to walk at least five minutes and then allowed to rest. Achieved heart rate reserve and time the spent training at 60-80% heart rate reserve will be quantified for each session. Subjective measures of effort will also be sampled using the Borg Scale.

Active Comparator: Speed based training study:
Each training session will begin by determining the fastest walking speed that an individual asserts that they can maintain for five minutes. The training time will then begin. Individuals will be encouraged to walk at least five minutes and then be allowed to rest. Speed will be progressed for each individual every 1-2 weeks at increments between 0.02 m/s and 0.08 m/s. Treadmill inclination will remain at 0°. Participants will be allowed to use the handrail or forearm support while being encouraged to walk without support if possible. Achieved heart rate reserve and the time the spent training at 60-80% heart rate reserve will be quantified for each session. Subjective measures of effort will also be sampled using the Borg Scale.
Other: Speed Based Training
Speed based training study: Individuals will train at the fastest walking speed that an individual asserts that they can maintain for five minutes. The training time will then begin. Individuals will be encouraged to walk at least five minutes and then be allowed to rest. Speed will be progressed for each individual every 1-2 weeks at increments between 0.02 m/s and 0.08 m/s. Treadmill inclination will remain at 0°. Participants will be allowed to use the handrail or forearm support while being encouraged to walk without support if possible. Achieved heart rate reserve and the time the spent training at 60-80% heart rate reserve will be quantified for each session. Subjective measures of effort will also be sampled using the Borg Scale.




Primary Outcome Measures :
  1. 10 meter walk test [ Time Frame: Baseline to three months ]
    Individual will walk 10 m "at a speed that feels the most comfortable". The time it takes for the individual to walk the middle 6 meters is quantified allowing for an acceleration and deceleration.


Secondary Outcome Measures :
  1. Peak Strength [ Time Frame: Baseline to three months ]
    Peak isometric force generate of the ankle plantar flexors will be measured with dynamometer. Individuals will generate a maximum amount of force against the arm of the dynamometer and the maximum plantarflexor torque generation of the ankle will be quantified

  2. Balance [ Time Frame: Baseline to three months ]
    The Mini Best clinical test will be used to assess balance of these individuals.

  3. Timed up and go [ Time Frame: Baseline to three months ]
    The individual sits in a chair with their back against the chair back On the command "go", the individual rises from the chair, walks 3 meters, turns, walks back to the chair and sits down. Timing begins at the instruction "go" and stops when the individual is seated



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria: unilateral stroke that resulted in hemiplegia (> 6 months post injury), older than 18 years of age, ability to walk independently, medically stable (controlled hypertension, no arrhythmia, stable cardiovascular status), and able to provide written informed consent.

Exclusion Criteria:

  • history of serious cardiac disease (e.g., myocardial infarction), uncontrolled blood pressure, presence of cerebellar and brainstem deficits, severe cognitive disorder, inability to follow simple commands, uncontrolled respiratory or metabolic disorders, major or acute musculoskeletal problems.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174392


Locations
United States, Alabama
University of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
National Institutes of Health (NIH)
Investigators
Principal Investigator: Christopher P Hurt, PhD University of Alabama at Birmingham

Responsible Party: Christopher Hurt, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03174392     History of Changes
Other Study ID Numbers: F170330006
UL1TR001417 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christopher Hurt, University of Alabama at Birmingham:
Exercise
Multimodal
Balance
Resistance
Mobility

Additional relevant MeSH terms:
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors