Effectiveness of Task Specific Home Exercise Program

NCT ID: NCT06486116

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-01-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Individualized Task Specific Physical Therapy Home Exercise Program

Physical Therapy Home Exercise program based on specific outcome measure findings.

Group Type EXPERIMENTAL

Task Specific Physical Therapy Home Program

Intervention Type BEHAVIORAL

Home exercise program based on specific findings from physical therapy evaluations.

Generic physical therapy home exercise program

Generalized fitness-based exercise program

Group Type ACTIVE_COMPARATOR

Task Specific Physical Therapy Home Program

Intervention Type BEHAVIORAL

Home exercise program based on specific findings from physical therapy evaluations.

Interventions

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Task Specific Physical Therapy Home Program

Home exercise program based on specific findings from physical therapy evaluations.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Definitive diagnosis of Multiple sclerosis

* Ability to walk for at least 30 seconds unassisted with or without assistive device
* Ability to read, comprehend and sign an informed consent
* Is able to attend a 2 outpatient evaluation sessions 6 weeks apart
* Between the ages of 18 and 75

Exclusion Criteria

* Evidence of recent MS exacerbation

* Any orthopedic, cardiopulmonary, or non- MS neurologic condition that prohibits participation in a Physical therapy program
* Be currently receiving outpatient physical therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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New York Presbyterian Brooklyn Methodist Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karen Blitz-Shabbir

Neurologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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New York Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Pearlia Fullard

Role: primary

718-780-5584

Joy J Rutherford, BS

Role: backup

718-780-7715

References

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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.

Reference Type BACKGROUND
PMID: 34343867 (View on PubMed)

Dalgas U, Ingemann-Hansen T, Stenager E. Physical Exercise and MS Recommendations. Int MS J. 2009 Apr;16(1):5-11.

Reference Type BACKGROUND
PMID: 19413920 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32310197 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14742602 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2803071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27903937 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16372431 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32607064 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31762543 (View on PubMed)

Other Identifiers

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2160034

Identifier Type: -

Identifier Source: org_study_id

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