Multimodal Exercise Training Poststroke

August 31, 2020 updated by: Christopher Hurt, University of Alabama at Birmingham

Exercise Training in a Novel Training Environment Compared to Increased Treadmill Speed During Walking With Individuals Poststroke

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to three months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline to three months
Balance
Time Frame: Baseline to three months
The Mini Best clinical test will be used to assess balance of these individuals.
Baseline to three months
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
Baseline to three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher P Hurt, PhD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • F170330006
  • UL1TR001417 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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