Multimodal Exercise Training Poststroke

NCT03174392 | Completed DMC

• 2 other identifiers: F170330006UL1TR001417
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise; Stroke

Keywords

Exercise; Multimodal; Balance; Resistance; Mobility

Outcome Measures

Primary Outcomes (1)

• 10 meter walk test

  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 Outcomes (3)

• Peak Strength

  Baseline to three months

• Balance

  Baseline to three months

• Timed up and go

  Baseline to three months

Study Arms (2)

Resistance based training study:

EXPERIMENTAL

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

Speed based training study:

ACTIVE COMPARATOR

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

Interventions

Resistance Based Training OTHER

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.

Resistance based training study:

Speed Based Training OTHER

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.

Speed based training study:

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Alabama At Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Motor Activity; Stroke

Condition Hierarchy (Ancestors)

Behavior; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Christopher P Hurt, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 2, 2017
• Study Start: July 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

US (1)