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Treadmill Walking Exercise Training Effects on Cognition and Brain Function in Multiple Sclerosis: A Systematically-Developed Randomized Controlled Trial

Award Number: R01HD091155
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Cognitive impairment is highly prevalent, poorly-managed, and disabling in persons with multiple sclerosis (MS). Exercise training is a promising approach for managing cognitive dysfunction in MS; however, results from previous randomized controlled trials (RCTs) have been equivocal. This is inconsistent with the well- established literature from the general population that consistently documents beneficial effects of exercise training on cognition and brain function. Indeed, the MS RCTs suffer from significant methodological flaws and are not on par with the rigor of exercise training studies on cognition in the general population. To that end, we recently completed a line of research that identified progressive (i.e., both intensity and duration) treadmill walking exercise as an optimal exercise training intervention for improving cognitive processing speed (CPS; the most commonly impaired cognitive domain in MS) and thalamocortical resting-state functional connectivity (RSFC), in particular, among fully-ambulatory persons with MS. To that end, the purpose of the present proposal is to conduct an adequately-powered, single-blind, RCT, using an active control condition for improving CPS and brain function in cognitively-impaired persons with MS at a single research site. This study will examine the effects of 3-months of supervised, progressive chronic treadmill walking exercise (designed based on pilot work) compared with a placebo control condition (i.e., stretching- and-toning activities) on CPS, fMRI (i.e., thalamocortical RSFC), and functional outcomes in 88 persons with MS who present with slowed CPS. We will collect data on CPS, thalamocortical RSFC, and functional outcomes at baseline and follow-up (i.e., at the conclusion of the 3-month intervention period) time points. We hypothesize that treadmill walking exercise training will result in significant improvements in CPS, thalamocortical RSFC, and functional outcomes. We further speculate that improvements in thalamocortical RSFC might explain exercise-related improvements in CPS. If successful, the proposed study will provide the first Class I evidence for the effects of treadmill walking exercise training as a rehabilitative approach to improve CPS, its neural correlate, and functional consequences in persons with MS who need such an intervention the most. This line of research will lay the groundwork for the development of exercise training guidelines that can be adapted by clinicians for use by MS patients for specifically improving cognition and brain health. Such an evidence-based approach for rehabilitation, using exercise training, is paramount considering the prevalent, disabling, and poorly-managed nature of MS-related CPS impairment. This is consistent with the National Center for Medical Rehabilitation Research’s mission to foster development of scientific knowledge needed to enhance the health, productivity, independence, and quality of life of persons with physical disabilities.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2022 ( Subtotal = $386,330 )
2022	2022	KESSLER FOUNDATION, INC.	120 EAGLE ROCK AVE STE 100	EAST HANOVER	NJ	07936	MORRIS	USA	Child Health and Human Development Extramural Research	000	5	8/26/2022	NON-COMPETING CONTINUATION	$380,343
2022	2019	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Child Health and Human Development Extramural Research	001	2	9/26/2022	NON-COMPETING CONTINUATION	$5,987


Issue Date FY: 2021 ( Subtotal = $388,889 )
2021	2021	KESSLER FOUNDATION, INC.	120 EAGLE ROCK AVE STE 100	EAST HANOVER	NJ	07936	MORRIS	USA	Child Health and Human Development Extramural Research	003	4	8/27/2021	NON-COMPETING CONTINUATION	$388,889
2021	2020	KESSLER FOUNDATION, INC.	120 EAGLE ROCK AVE STE 100	EAST HANOVER	NJ	07936	MORRIS	USA	Child Health and Human Development Extramural Research	000	3	11/2/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2021	2020	KESSLER FOUNDATION, INC.	120 EAGLE ROCK AVE STE 100	EAST HANOVER	NJ	07936	MORRIS	USA	Child Health and Human Development Extramural Research	002	3	6/1/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$223,607
2021	2019	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Child Health and Human Development Extramural Research	001	2	6/1/2021	NON-COMPETING CONTINUATION	-$223,607


Issue Date FY: 2020 ( Subtotal = $378,194 )
2020	2020	KESSLER FOUNDATION, INC.	120 EAGLE ROCK AVE STE 100	EAST HANOVER	NJ	07936	MORRIS	USA	Child Health and Human Development Extramural Research	003	3	9/4/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$378,194
2020	2019	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Child Health and Human Development Extramural Research	002	2	9/4/2020	NON-COMPETING CONTINUATION	$0
2020	2019	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Child Health and Human Development Extramural Research	000	2	3/3/2020	NON-COMPETING CONTINUATION	$0
2020	2019	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Child Health and Human Development Extramural Research	001	2	8/27/2020	NON-COMPETING CONTINUATION	$0


Issue Date FY: 2019 ( Subtotal = $370,020 )
2019	2019	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Child Health and Human Development Extramural Research	000	2	1/28/2019	NON-COMPETING CONTINUATION	$370,020


Issue Date FY: 2018 ( Subtotal = $361,808 )
2018	2018	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Child Health and Human Development Extramural Research	000	1	2/7/2018	NEW	$361,808


Grand Total All Awards = $1,885,241

Sum of Action Amount is $1,885,241;

Grand Total = $1,885,241

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Treadmill Walking Exercise Training Effects on Cognition and Brain Function in Multiple Sclerosis: A Systematically-Developed Randomized Controlled Trial

Award Number: R01HD091155

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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