Purpose: To determine whether pwMS will have greater improvements in gait with HIIGT as
compared to MICGT.
Primary Question: Does HIIGT results in greater improvements in gait parameters in pwMS than
MICGT? Secondary question: Will HIIGT result in greater improvements in balance, lower
extremity strength, lower extremity range of motion and HR when compared to MICGT in pwMS?
Hypothesis: HIIGT will result in greater improvements in gait parameters in pwMS than MICGT.
Justification: Previous research has shown that MICGT, moderate intensity interval training
and high intensity non-gait interval training is effective in pwMS (1)(2). HIIGT has been
shown to be effective in persons with stroke
- (3) but the effects of HIIGT on pwMS are not
known.
Outcomes and dissemination of information: We will present our findings at national
conferences and submit manuscripts of our findings to the appropriate peer reviewed journal.
The answers to our research questions will be found by using a randomized controlled to group
people pretest post test design.
1.
- - INFORMED CONSENT: Upon entering Hunter College Physical Therapy department,
participants will be greeted by dr.
Karpatkin and provided with an informed consent form
outlining the purpose of the study, the length of the study, the potential risks, and
the procedures.
2.
- - COLLECTION OF DEMOGRAPHICS: Participants will fill out a questionnaire collecting
demographics and subject characteristics information, such as age, gender, race,
phenotype of MS, ambulatory device used, medications used, years since diagnosis.
3.
- - COLLECTION OF SELF REPORT MEASURES: Patients will then will out the following self
report questionnaires Multiple Sclerosis Impact Scale 29 (MSIS 29): The MSIS 29 is a
questionnaire asking for participants' views about the impact of MS on their day-to-day
life, measuring coordination, fatigue, flexibility, muscle performance, muscle
tone/spasticity, balance/falls, reach and grasp, self-care, health and wellness,
leisure, quality of life, role function, social function, work in pwMS.
The Fatigue Severity Scale (FSS): The FSS is a short questionnaire that requires you to rate
your level of fatigue. The FSS questionnaire contains nine statements that rate the severity
of your fatigue symptoms. Read each statement and circle a number from 1 to 7, based on how
accurately it reflects your condition during the past week and the extent to which you agree
or disagree that the statement applies to you.
12 Item MS Walking Scale (MSWS-12): is a self-report measure of the impact that MS has on an
individual's ambulation. The participants read each statement and report how much MS has
limited them in the past two weeks on a scale of 1 to 5.
4
- - 6 minute walk test (6MWT): The 6MWT measures the distance an individual is able to walk
over a total of six minutes on a leveled surface indoors.
The goal is for the individual to
walk as far as possible in six minutes. The individual is allowed to self-pace and rest as
needed as they traverse back and forth along a marked walkway. We will also be measuring the
distance walked in each minute of the test and participants heart rate before, during and
after the test.
5
- - The Functional Gait Assessment (FGA): is used to assess postural stability and balance
during different tasks in populations of pwMS, Parkinson disease, spinal cord injuries,
stroke diagnosis, and vestibular disorders.
FGA is a modification of the Dynamic Gait Index
and was created to help decrease the ceiling effect and improve reliability.
6
- - Hand Held Dynamometry (HHD): is used to measure participants' strength in hip flexion,
hip extension, knee flexion, knee extension, ankle plantarflexion and dorsiflexion.
Measurements will be taken using a dynamometer.
7
- - Goniometry: is used to measure ranges of motion for participants' hip flexion, hip
extension, knee flexion, knee extension, ankle plantarflexion, and ankle dorsiflexion.
Measurements will be taken using a standard goniometer.
8
- - RANDOMIZATION INTO HIIGT GROUP AND MICGT GROUP: After collecting the information from the
questionnaires, the participants who meet the inclusion criteria will be randomly assigned
each participant into either the HIIGT or MICGT group, with each group having an equal number
of participants per group.
Randomization will be achieved by the participant pulling odd or
even numbers out of a hat. An even number will be placed in the HIIGT group and an odd number
into the MICGT group. Since the HIIGT represents a novel therapy it will be considered the
experimental group. Since the MICGT represents the standard of care it will be considered the
control group 7
- - DESCRIPTION OF HIIGT PROTOCOL: The protocol for HIIGT will be a total of 4
to 5 weeks including 4 weeks of the intervention, one day of pre-testing and one day of
post-testing.
Training entails a total of 25 minutes work with 3 minutes warm up of gentle
walking, then multiple rounds of 30 seconds of fast walking followed by 60 seconds of seated
rest. Fast walking will be defined to the participant as walking the fastest they can
comfortably. The participants will complete the cycle of 30 seconds work with 60 seconds rest
until they get to 23 minutes of total exercise and then a 2 minute cool down to make 25
minutes of total work. During the intervention each participant's heart rate, Rate of
Perceived Exertion, and distance walked will be recorded with a measuring wheel. During the
entire protocol, Dr. Karpatkin will be guarding the participant and a wheelchair will be
following the participant.
8- DESCRIPTION OF MICGT PROTOCOL: The protocol for MICGT will be a total of 4 to 5 weeks
including 4 weeks for the intervention, one day for pre-testing, and one for post-testing.
They will engage in continuous moderate walking for 25 minutes per session, 3 times a week
for 4 weeks. Moderate walking is defined as a pace the participant is able to comfortably
maintain for the 25 minutes. Dr. Karpatkin will be guarding during the full training, and a
wheel chair will follow behind the participant. During the intervention each participant's
heart rate, Rate of Perceived Exertion, and distance walked will be recorded with a measuring
wheel.
9
- - POST-TEST PROTOCOL: The post-test protocol will be the same as the pre-test.
Each
participant will complete the 6MWT, HHD for the lower extremity, Goniometric measures for the
lower extremity, and the FGA.
Gate endurance will be operationally defined by performance on the six minute walk test.
Fatigue will also be operationally defined by performance on the six minute walk test.
Balance performance will be operationally defined by performance on the functional gait
assessment tool. Lower extremity strength will be operationally defined as performance on
handheld dynamometry.
Lower extremity range of motion improvements will be operationally defined as pretest post
test improvements in goniometry.
Improvements in heart rate will be measured using pulse oximetry.
Data analysis plan:For all primary outcomes with ratio level data, we will conduct a 2X2
mixed-factor Analysis of Variance (ANOVA). The between-factor will be group type (HIIGT vs.#46;
MIGGT) and the within-factor will be time (pre-test vs.#46;post-test). For the FGA scores
(ordinal level data), we will use Generalized Estimating Equations GEEs instead.
We expect a homogenous sample in terms of age, gender, disease severity, and years since
onset. However, prior to conducting statistical analyses, we will test the relationship
between subject age, disease severity, and years since onset with primary outcome measures
using Pearsons correlations (for ratio data) and Spearman's rank correlation (for ordinal
data). We will use unpaired t-tests to compare differences in outcome measures between males
and females. If any of the subject-characteristic measures have a significant effect on the
primary outcome measures, they will be included as covariates or factors in the ANOVA model
or GEEs
