Effect of Multimodal Exercise Training on Walking Economy in Individuals With Parkinson's Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/23/2019 |
| Start Date: | March 18, 2019 |
| End Date: | March 2021 |
| Contact: | Andrew A Guccione, PT, PhD, DPT |
| Email: | aguccion@gmu.edu |
| Phone: | 703-993-4650 |
Effect of a 12-week Multimodal Exercise Intervention on Walking Economy, Fatigability, and Propulsion in Individuals With Parkinson's Disease
Sustained ambulation is a challenge for individuals with Parkinson's disease (PD) as walking
economy is frequently compromised. There are also various disease-related skeletal muscle
alterations that may contribute to performance fatigability during ambulation. Concomitantly,
individuals with PD experience substantial difficulty maintaining sustained forward
progression at push-off during the gait cycle due to diminished force production. Exercise is
commonly prescribed for these individuals, though traditional exercise approaches to PD have
often applied a "one impairment-one modality" paradigm that addresses each impairment
separately. Interventions to optimize movement should facilitate an individual's response to
the challenge of responding to a complex interplay of constraints that are also specific to a
task and its environmental context. Thus, there are multiple concurrent targets for exercise
interventions that may not fit easily within a "one impairment-one modality" model. A
multimodal intervention is designed to address an array of constraining impairments
concurrently. However, the evidence-base for multimodal exercise approaches is still
developing and far from conclusive.
The purpose of this study is to demonstrate that multimodal overground locomotion training
(OLT) can promote walking economy during sustained overground ambulation in individuals with
PD, and produce concurrent secondary effects that decrease performance fatigability and
increase propulsion. The aims of this study are to 1) Evaluate walking economy during
sustained overground walking after 12 weeks of multimodal OLT, 2) Evaluate secondary effects
of OLT.
economy is frequently compromised. There are also various disease-related skeletal muscle
alterations that may contribute to performance fatigability during ambulation. Concomitantly,
individuals with PD experience substantial difficulty maintaining sustained forward
progression at push-off during the gait cycle due to diminished force production. Exercise is
commonly prescribed for these individuals, though traditional exercise approaches to PD have
often applied a "one impairment-one modality" paradigm that addresses each impairment
separately. Interventions to optimize movement should facilitate an individual's response to
the challenge of responding to a complex interplay of constraints that are also specific to a
task and its environmental context. Thus, there are multiple concurrent targets for exercise
interventions that may not fit easily within a "one impairment-one modality" model. A
multimodal intervention is designed to address an array of constraining impairments
concurrently. However, the evidence-base for multimodal exercise approaches is still
developing and far from conclusive.
The purpose of this study is to demonstrate that multimodal overground locomotion training
(OLT) can promote walking economy during sustained overground ambulation in individuals with
PD, and produce concurrent secondary effects that decrease performance fatigability and
increase propulsion. The aims of this study are to 1) Evaluate walking economy during
sustained overground walking after 12 weeks of multimodal OLT, 2) Evaluate secondary effects
of OLT.
Protocol Overview: Subjects will be recruited from the greater Washington D.C. metro area.
Individuals interested in participating as subjects will complete initial verbal screening to
determine eligibility for inclusion. Those subjects who volunteer to participate will then be
consented and enrolled for participation if exclusion and inclusion criteria are met.
Visit 1: (~ 90 minutes) Subjects will fill out a medical history form. Height and weight
measurements will then be taken. The Hoehn and Yahr and Mini-Mental State Exams will then be
administered. Subjects performing the 10-minute walk test will be fitted with a portable
metabolic unit consisting of a face mask and torso apparatus. Wearable sensors will be
secured to both arms, trunk, and legs. Prior to starting the test, subjects will stand in a
resting position for at least 3 minutes to gain resting metabolic data. The subjects will
then be asked to walk as far as they (the subjects) can in 10 minutes. Following the
10-minute walking period, subjects will again stand in a resting position to obtain recovery
data. Subjects will then be provided a 10-20 minute resting period during the transition to
the second test. For the second test, subjects will be fitted with reflective markers at
pre-specified anatomical landmarks used in a standardized gait marker set, for example medial
and lateral knee and ankle joints. Electromyography (EMG) sensors will be placed on lower
limb muscles. Subjects will then be asked to walk at both their preferred and fast walking
speed over a 6 meter platform with embedded force plates. Subjects will be asked to perform
as many trials as necessary to collect sufficient force plate data. Following this test,
subjects will be given the opportunity for a rest period if required before ending the
testing day. For those subjects who start with the gait propulsion test, the testing order
will include the same procedures yet in the reversed order.
Visits 2-25: (~1 hour each) For these visits, subjects will perform an overground multimodal
locomotor training protocol. Subjects will train individually with 1-2 trained instructors.
Subjects will wear a Polar chest strap and a research grade pedometer during each session to
enable instructors to modify training within the session to maintain a target intensity zone.
The training protocol covers 12 weeks with two sessions per week for a total of 24 sessions.
Visit 26: (~90 minutes): Subjects will repeat the same testing procedures as they did in
visit 1 in the same order as they did, determined by the initial randomization process.
Study Procedures:
10-Minute Walk Test: The purpose of this test is to provide a method of perturbation for
measuring both performance and perceived fatigability. Subjects will wear a fitted face mask
and a torso unit as part of a portable metabolic unit. Wearable sensors will be secured on
the torso, upper and lower limbs to measure gait characteristics. Subjects will rest in a
standing position for at least 3 minutes prior to beginning this test to collect baseline
data. Subjects will then walk as far as they can over a 10-minute interval or until they have
to stop walking. Distance covered will be recorded at at 2.5-minute intervals throughout the
test and at the end of the time walked if not the full 10 minutes. Velocity will be computed
from the distances covered at the time intervals (meters/sec). The 10-minute walk test will
be performed during the pre-intervention testing visit and post-intervention testing visit.
Following the 10-minute walk period (or total time if ended early) subjects will rest in the
standing position to obtain recovery data for at least 6 minutes.
Gait Propulsion Testing: Subjects will be outfitted with reflective markers comprised of a
standardized full-body marker set for motion capture analysis. EMG sensors will be placed on
muscle bellies of lower limb muscles. To establish the maximum voluntary contraction,
subjects will be asked to contract muscles against resistance. Subjects will be asked to
stand for system calibration for less than one minute and may be asked to move various limbs
through a range of motion to ensure accuracy of the system prior to starting the test.
Subjects will then be asked to walk across a 6-meter platform with embedded force plates
enclosed by safety rails at their preferred and fast walking speed. Subjects will perform
approximately 20-30 passes to ensure sufficient data collection by the force plates as
appropriate contact with the force plate must be made for valid measurement. Once sufficient
data has been collected, markers and sensors will be removed and the subject will be offered
a seated rest period if needed.
Multimodal Exercise Intervention: The intent of the multimodal training intervention is to
encompass cardiovascular adaptations and locomotor improvements. To promote cardiovascular
adaptation, training sessions will be adjusted in real-time to achieve a pre-determined
target heart rate (HR) zone for each subject. HR will be monitored continuously during each
training session. The target HR intensity during training sessions will be 60% of the
subjects predicted maximal HR. The target HR zone will be 60% of predicated maximal HR +/-
5%. The subjects predicted maximal HR will be calculated using the formula: 220-age. Training
procedures will include drills based on gait initiation and termination, agility, muscular
power, and steady state actions. Drills will be conducted with an emphasis on direction
change beyond usual forward progression. As subjects become familiar with the various drills,
instructors will gradually increase the complexity, speed, and volume.
Propulsion Measures: For this study, propulsion will be defined by anterior peak positive
ground reaction force (GRF) during overground walking. The force plates measure the GRF in
response to the force placed upon it by the subject. In conjunction with motion capture
analysis, the propulsive phase of gait can be determined and within that phase the anterior
peak vector will be calculated. Peak propulsive force will be determined as the maxima (one
point) of the anterior GRF.
Performance Fatigability Test Scoring: Performance fatigability is the rate or extent to
which tissue, organ, system or total body function (fatigue) declines in response to a given
task. After a 10-minute period of quiet rest in the sitting position, subjects will complete
the 10-minute walk test. Distance covered will be recorded at the 2.5-minute interval of the
test and for the total test. Velocities for the entire test (total distance walked / total
minutes of test) and the first 2.5 minutes of the test (distance covered in the first 2.5
minutes / 2.5 minutes) will be calculated. The fractional change in velocity will then be
computed as the quotient of total test velocity / 2.5 minute velocity. For example if the
total test velocity and the 2.5-minute velocity were both 82 meters/minute, the total test
velocity would be 100% of the velocity at 2.5 minutes. However, if the total test velocity
were 80 meters/min and the velocity at 2.5 minutes were 82 meters/minute, then the total test
velocity would be only .98 of the 2.5-minute velocity. To calculate the performance
fatigability score, the fractional change in velocity will be divided by the distance
covered. Thus any 2 subjects could have similar change in velocity scores (for example 0.5)
but different total distances (100 versus 200 meters). In this case the performance
fatigability score for the first subject would be 0.5/100 = 0.005 versus .5/200 = 0.0025.
Scores are multiplied by 1000 to facilitate reporting. A small score indicates lower
fatigability. Thus, even though the fractional change in velocity was similar for the 2
hypothetical subjects above, fatigability was less in the second subject as demonstrated by a
lower performance fatigability score.
Perceived Fatigability Test Scoring: Perceived fatigability is the rate or magnitude of
change in feelings of tiredness or weariness (symptoms of fatigue or perceived fatigue) in
response to a given task. After the initial 10-minute sitting rest period, subjects will rate
their perception of fatigue or vigor using the left side of the Fatigue and Fatigability
Scale. Following the 10-minute walk test, subjects will be asked "compared to when you (the
subject) started, how would you (the subject) rate your (the subject's) level of tiredness
now" using the right side of the scale. The left side is considered a measure of fatigue
because a change in fatigue was not assessed. The right side is considered to be a rating of
fatigability because it assesses the change in tiredness. The score for the change in
tiredness is then normalized to the total distance covered to calculate the perceived
fatigability score: perceived fatigability = (change in tiredness / total distance walked) x
100 (multiplied by 100 to facilitate reporting and comparison).
Cardiopulmonary Gas Exchange Analyses: All gas exchange will be collected using a wearable
metabolic unit.The unit is calibrated prior to each test.
Motion capture system: Infrared cameras will capture movements of reflective markers worn by
subjects within the volume. Reflective markers will be placed about the subject according to
a predetermined full body gait marker model.
EMG sensors for measurement of muscle activity: EMG Electrodes are secured to the subject's
skin over the muscle belly of interest. The sensor and electrode are covered with tape to
minimize movement artifacts.
Force plates for GRF measurement: 4 force-plates are embedded in a 6 meter walkway. The
force-plates measure x, y and z axes of the force and moment components, with the output
signal fed into an amplifier.
Wearable sensors for measurement of gait characteristics: Wearable sensors contain
accelerometers, gyroscopes, and magnetometers. Measurements are collected on the x, y, and z
axes at a sample rate of 128 Hz. These sensors are attached to the preselected locations on
the subject's body. This data is either wirelessly streamed via an access point and/or logged
and stored in the sensor. Participants will also wear a step counter during each training
sessions to record the total number of steps taken
Questionnaire:
Medical History Form: Subjects will fill out the medical history form on visit 1.
Testing/Forms:
Hoehn and Yahr: The Hoehn and Yahr scale (HY) is a widely used clinical rating scale, which
defines broad categories of motor function in Parkinson's disease. This test will be
administered by the researchers on visit 1.
Standardized Mini-mental State Exam: This test will be administered by researchers on visit 1
and is a 12-point questionnaire that addresses cognitive function.
Individuals interested in participating as subjects will complete initial verbal screening to
determine eligibility for inclusion. Those subjects who volunteer to participate will then be
consented and enrolled for participation if exclusion and inclusion criteria are met.
Visit 1: (~ 90 minutes) Subjects will fill out a medical history form. Height and weight
measurements will then be taken. The Hoehn and Yahr and Mini-Mental State Exams will then be
administered. Subjects performing the 10-minute walk test will be fitted with a portable
metabolic unit consisting of a face mask and torso apparatus. Wearable sensors will be
secured to both arms, trunk, and legs. Prior to starting the test, subjects will stand in a
resting position for at least 3 minutes to gain resting metabolic data. The subjects will
then be asked to walk as far as they (the subjects) can in 10 minutes. Following the
10-minute walking period, subjects will again stand in a resting position to obtain recovery
data. Subjects will then be provided a 10-20 minute resting period during the transition to
the second test. For the second test, subjects will be fitted with reflective markers at
pre-specified anatomical landmarks used in a standardized gait marker set, for example medial
and lateral knee and ankle joints. Electromyography (EMG) sensors will be placed on lower
limb muscles. Subjects will then be asked to walk at both their preferred and fast walking
speed over a 6 meter platform with embedded force plates. Subjects will be asked to perform
as many trials as necessary to collect sufficient force plate data. Following this test,
subjects will be given the opportunity for a rest period if required before ending the
testing day. For those subjects who start with the gait propulsion test, the testing order
will include the same procedures yet in the reversed order.
Visits 2-25: (~1 hour each) For these visits, subjects will perform an overground multimodal
locomotor training protocol. Subjects will train individually with 1-2 trained instructors.
Subjects will wear a Polar chest strap and a research grade pedometer during each session to
enable instructors to modify training within the session to maintain a target intensity zone.
The training protocol covers 12 weeks with two sessions per week for a total of 24 sessions.
Visit 26: (~90 minutes): Subjects will repeat the same testing procedures as they did in
visit 1 in the same order as they did, determined by the initial randomization process.
Study Procedures:
10-Minute Walk Test: The purpose of this test is to provide a method of perturbation for
measuring both performance and perceived fatigability. Subjects will wear a fitted face mask
and a torso unit as part of a portable metabolic unit. Wearable sensors will be secured on
the torso, upper and lower limbs to measure gait characteristics. Subjects will rest in a
standing position for at least 3 minutes prior to beginning this test to collect baseline
data. Subjects will then walk as far as they can over a 10-minute interval or until they have
to stop walking. Distance covered will be recorded at at 2.5-minute intervals throughout the
test and at the end of the time walked if not the full 10 minutes. Velocity will be computed
from the distances covered at the time intervals (meters/sec). The 10-minute walk test will
be performed during the pre-intervention testing visit and post-intervention testing visit.
Following the 10-minute walk period (or total time if ended early) subjects will rest in the
standing position to obtain recovery data for at least 6 minutes.
Gait Propulsion Testing: Subjects will be outfitted with reflective markers comprised of a
standardized full-body marker set for motion capture analysis. EMG sensors will be placed on
muscle bellies of lower limb muscles. To establish the maximum voluntary contraction,
subjects will be asked to contract muscles against resistance. Subjects will be asked to
stand for system calibration for less than one minute and may be asked to move various limbs
through a range of motion to ensure accuracy of the system prior to starting the test.
Subjects will then be asked to walk across a 6-meter platform with embedded force plates
enclosed by safety rails at their preferred and fast walking speed. Subjects will perform
approximately 20-30 passes to ensure sufficient data collection by the force plates as
appropriate contact with the force plate must be made for valid measurement. Once sufficient
data has been collected, markers and sensors will be removed and the subject will be offered
a seated rest period if needed.
Multimodal Exercise Intervention: The intent of the multimodal training intervention is to
encompass cardiovascular adaptations and locomotor improvements. To promote cardiovascular
adaptation, training sessions will be adjusted in real-time to achieve a pre-determined
target heart rate (HR) zone for each subject. HR will be monitored continuously during each
training session. The target HR intensity during training sessions will be 60% of the
subjects predicted maximal HR. The target HR zone will be 60% of predicated maximal HR +/-
5%. The subjects predicted maximal HR will be calculated using the formula: 220-age. Training
procedures will include drills based on gait initiation and termination, agility, muscular
power, and steady state actions. Drills will be conducted with an emphasis on direction
change beyond usual forward progression. As subjects become familiar with the various drills,
instructors will gradually increase the complexity, speed, and volume.
Propulsion Measures: For this study, propulsion will be defined by anterior peak positive
ground reaction force (GRF) during overground walking. The force plates measure the GRF in
response to the force placed upon it by the subject. In conjunction with motion capture
analysis, the propulsive phase of gait can be determined and within that phase the anterior
peak vector will be calculated. Peak propulsive force will be determined as the maxima (one
point) of the anterior GRF.
Performance Fatigability Test Scoring: Performance fatigability is the rate or extent to
which tissue, organ, system or total body function (fatigue) declines in response to a given
task. After a 10-minute period of quiet rest in the sitting position, subjects will complete
the 10-minute walk test. Distance covered will be recorded at the 2.5-minute interval of the
test and for the total test. Velocities for the entire test (total distance walked / total
minutes of test) and the first 2.5 minutes of the test (distance covered in the first 2.5
minutes / 2.5 minutes) will be calculated. The fractional change in velocity will then be
computed as the quotient of total test velocity / 2.5 minute velocity. For example if the
total test velocity and the 2.5-minute velocity were both 82 meters/minute, the total test
velocity would be 100% of the velocity at 2.5 minutes. However, if the total test velocity
were 80 meters/min and the velocity at 2.5 minutes were 82 meters/minute, then the total test
velocity would be only .98 of the 2.5-minute velocity. To calculate the performance
fatigability score, the fractional change in velocity will be divided by the distance
covered. Thus any 2 subjects could have similar change in velocity scores (for example 0.5)
but different total distances (100 versus 200 meters). In this case the performance
fatigability score for the first subject would be 0.5/100 = 0.005 versus .5/200 = 0.0025.
Scores are multiplied by 1000 to facilitate reporting. A small score indicates lower
fatigability. Thus, even though the fractional change in velocity was similar for the 2
hypothetical subjects above, fatigability was less in the second subject as demonstrated by a
lower performance fatigability score.
Perceived Fatigability Test Scoring: Perceived fatigability is the rate or magnitude of
change in feelings of tiredness or weariness (symptoms of fatigue or perceived fatigue) in
response to a given task. After the initial 10-minute sitting rest period, subjects will rate
their perception of fatigue or vigor using the left side of the Fatigue and Fatigability
Scale. Following the 10-minute walk test, subjects will be asked "compared to when you (the
subject) started, how would you (the subject) rate your (the subject's) level of tiredness
now" using the right side of the scale. The left side is considered a measure of fatigue
because a change in fatigue was not assessed. The right side is considered to be a rating of
fatigability because it assesses the change in tiredness. The score for the change in
tiredness is then normalized to the total distance covered to calculate the perceived
fatigability score: perceived fatigability = (change in tiredness / total distance walked) x
100 (multiplied by 100 to facilitate reporting and comparison).
Cardiopulmonary Gas Exchange Analyses: All gas exchange will be collected using a wearable
metabolic unit.The unit is calibrated prior to each test.
Motion capture system: Infrared cameras will capture movements of reflective markers worn by
subjects within the volume. Reflective markers will be placed about the subject according to
a predetermined full body gait marker model.
EMG sensors for measurement of muscle activity: EMG Electrodes are secured to the subject's
skin over the muscle belly of interest. The sensor and electrode are covered with tape to
minimize movement artifacts.
Force plates for GRF measurement: 4 force-plates are embedded in a 6 meter walkway. The
force-plates measure x, y and z axes of the force and moment components, with the output
signal fed into an amplifier.
Wearable sensors for measurement of gait characteristics: Wearable sensors contain
accelerometers, gyroscopes, and magnetometers. Measurements are collected on the x, y, and z
axes at a sample rate of 128 Hz. These sensors are attached to the preselected locations on
the subject's body. This data is either wirelessly streamed via an access point and/or logged
and stored in the sensor. Participants will also wear a step counter during each training
sessions to record the total number of steps taken
Questionnaire:
Medical History Form: Subjects will fill out the medical history form on visit 1.
Testing/Forms:
Hoehn and Yahr: The Hoehn and Yahr scale (HY) is a widely used clinical rating scale, which
defines broad categories of motor function in Parkinson's disease. This test will be
administered by the researchers on visit 1.
Standardized Mini-mental State Exam: This test will be administered by researchers on visit 1
and is a 12-point questionnaire that addresses cognitive function.
Inclusion Criteria:
- 18 years of age or older
- diagnosis of idiopathic Parkinson's Disease, mild to moderate (Hoehn and Yahr score
less than or equal to 3)
- speaks English
- able to ambulate without requiring an assistive device
Exclusion Criteria:
- neurological disease diagnosis other than PD
- uncontrolled cardiovascular, pulmonary, neurological, or metabolic disease which may
impact the ability to exercise or in which exercise is contraindicated
- any medications, such as beta-blockers, that may alter HR or metabolic data
- cognitive or psychiatric impairment precluding informed consent or ability to
following instructions
- mini-Mental State Examination score <24
- pregnancy
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