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The purpose of this study is to compare the effectiveness of 2 different types of Home Exercise Programs (HEP) on mobility in persons with Multiple Sclerosis (MS). Specifically, we will be comparing the Standard of Care (SOC) a program based on aerobic conditioning and calisthenics to a Task Specific Program (TSP).
Primary Question: Will persons with who receive a Task Specific HEP have greater improvement in mobility than those who receive the SOC? Secondary question: Will a task specific HEP be as well tolerated as the SOC HEP by persons with MS
Persons with MS have been shown to benefit from exercise to address the symptoms of their disease. Exercise programs are customarily given by Physical Therapists (PT) in either an inpatient or outpatient setting. Outpatient PT is typically augmented with a Home exercise Program (HEP) which is meant to enhance the work that is done directly with the PT. Since the amount of exercise done at home is often greater than what is done with the PT, the HEP is of great importance.
However, the types of exercise that are the most useful for useful for persons with MS has not been established. Previous research has shown that due to the unique ways in which MS can affect the nervous system, exercise programs that may be appropriate for persons without MS may not be ideal for those that have the disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized Task Specific Physical Therapy Home Exercise Program | Experimental | Physical Therapy Home Exercise program based on specific outcome measure findings. |
|
| Generic physical therapy home exercise program | Active Comparator | Generalized fitness-based exercise program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Task Specific Physical Therapy Home Program | Behavioral | Home exercise program based on specific findings from physical therapy evaluations. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 Minute Walk Test | Participant walks at best comfortable pace for 6 consecutive minutes; total distance walked and distance per minute is measured. | Measured before and after each 4 weeks |
| The Functional Gait Assessment | A measure of walking balance assessed by participant's performance on specific task. | Measured before and after each 4 weeks |
| The Mini Balance Evaluation Systems Test (MBEST) | Assessment of participant balance during reactive anticipatory, dynamic and sensory aspects of balance tasks. | Measured before and after each 4 weeks |
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Inclusion Criteria:
Definitive diagnosis of Multiple sclerosis
Exclusion Criteria:
Evidence of recent MS exacerbation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Brooklyn Methodist Hospital | Recruiting | Brooklyn | New York | 11215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34343867 | Background | Ghahfarrokhi MM, Banitalebi E, Negaresh R, Motl RW. Home-Based Exercise Training in Multiple Sclerosis: A Systematic Review with Implications for Future Research. Mult Scler Relat Disord. 2021 Oct;55:103177. doi: 10.1016/j.msard.2021.103177. Epub 2021 Jul 27. | |
| 19413920 | Background | Dalgas U, Ingemann-Hansen T, Stenager E. Physical Exercise and MS Recommendations. Int MS J. 2009 Apr;16(1):5-11. |
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There is a plan to make IPD and related data dictionaries available. The specific individual participant data sets are to be shared are, collected IPD, all IPD that underlie results in a publication.
Data will be shared following publication of our findings in an article in the appropriate peered review journal.
Requests for data will be considered on an individual basis by the Principal Investigator.
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 32310197 | Background | Ozkul C, Guclu-Gunduz A, Eldemir K, Apaydin Y, Gulsen C, Yazici G, Soke F, Irkec C. Effect of task-oriented circuit training on motor and cognitive performance in patients with multiple sclerosis: A single-blinded randomized controlled trial. NeuroRehabilitation. 2020;46(3):343-353. doi: 10.3233/NRE-203029. |
| 14742602 | Background | McGuigan C, Hutchinson M. The multiple sclerosis impact scale (MSIS-29) is a reliable and sensitive measure. J Neurol Neurosurg Psychiatry. 2004 Feb;75(2):266-9. |
| 2803071 | Background | Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022. |
| 27903937 | Background | Goldman MD, Ward MD, Motl RW, Jones DE, Pula JH, Cadavid D. Identification and validation of clinically meaningful benchmarks in the 12-item Multiple Sclerosis Walking Scale. Mult Scler. 2017 Sep;23(10):1405-1414. doi: 10.1177/1352458516680749. Epub 2016 Dec 7. |
| 16372431 | Background | Savci S, Inal-Ince D, Arikan H, Guclu-Gunduz A, Cetisli-Korkmaz N, Armutlu K, Karabudak R. Six-minute walk distance as a measure of functional exercise capacity in multiple sclerosis. Disabil Rehabil. 2005 Nov 30;27(22):1365-71. doi: 10.1080/09638280500164479. |
| 32607064 | Background | Forsberg A, Andreasson M, Nilsagard Y. The Functional Gait Assessment in People with Multiple Sclerosis: Validity and Sensitivity to Change. Int J MS Care. 2017 Mar-Apr;19(2):66-72. doi: 10.7224/1537-2073.2015-061. |
| 31762543 | Background | Potter K, Bowling R, Kavanagh L, Stone A, Witt B, Wooldridge A. Reliability, Validity, and Responsiveness of the Mini-Balance Evaluation Systems Test in Ambulatory Individuals with Multiple Sclerosis. Physiother Can. 2019 Fall;71(4):327-334. doi: 10.3138/ptc-2018-0071. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |