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Examining the Effects of a Remotely-delivered, Racially-tailored Exercise Training Program for Immediate and Sustained Improvements in Walking Dysfunction, Symptoms, and Health-related Quality of Life (HRQOL) Among African-Americans With Multiple Sclerosis (MS) Residing in Rural Environments. (TEAAMS)

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guidelines for Exercise in Multiple Sclerosis (GEMS)
FLEX Stretching and Toning Program
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Rural, Walking dysfunction, Health-Related Quality of Life, African-American

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • English as primary language
  • Identify as African-American or Black
  • Age of 18 years or older
  • Diagnosis of MS
  • Relapse free in the past 30 days
  • Internet and email access
  • Willingness to complete the outcome questionnaires
  • Willingness to undergo randomization
  • Insufficient physical activity (not meeting current physical activity guidelines based on GLTEQ)
  • Mild-moderate ambulatory disability (MSWS-12 score between 25-49 & PDDS score between 2-4)

Exclusion Criteria:

  • Individuals not meeting above inclusion criteria
  • Individuals with moderate to high risk for contraindications of possible injury or death when undertaking strenuous or maximal exercise (PARQ).

Sites / Locations

  • University of Illinois at ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Guidelines for Exercise in Multiple Sclerosis (GEMS)

FLEX Stretching and Toning Program

Arm Description

Participants in this condition will receive a 4-month home-based, remotely supported aerobic and resistance exercise program based on the Guidelines for Exercise in Multiple Sclerosis (GEMS).

Participants in this condition will receive a 4-month home-based, remotely supported stretching program emphasizing flexibility and range of motion as important components of fitness based on Stretching for People with MS: An Illustrated Manual from the National MS Society.

Outcomes

Primary Outcome Measures

Walking Dysfunction
Multiple Sclerosis Walking Scale-12 (MSWS-12); scores range between 0 (min) and 100 (max), higher scores reflect greater walking problems.

Secondary Outcome Measures

Disability
Patient Determined Disease Steps (PDDS) scale; scores range between 0 (min) and 8 (max), higher score reflect greater perceived disability.
Fatigue Severity
Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity.
Depressive Symptoms
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.
Anxiety
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.
Health-related Quality of Life (HRQOL)
Multiple Sclerosis Impact Scale (MSIS-29); scores range between 0 (min) and 100 (max), higher scores indicate greater impact of disease on daily function (i.e. worse outcomes).

Full Information

First Posted
August 23, 2022
Last Updated
October 31, 2022
Sponsor
University of Illinois at Chicago
Collaborators
University of Alabama at Birmingham, Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT05516537
Brief Title
Examining the Effects of a Remotely-delivered, Racially-tailored Exercise Training Program for Immediate and Sustained Improvements in Walking Dysfunction, Symptoms, and Health-related Quality of Life (HRQOL) Among African-Americans With Multiple Sclerosis (MS) Residing in Rural Environments.
Acronym
TEAAMS
Official Title
Promotion of Exercise Behavior Among Rural-Residing African-Americans With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
University of Alabama at Birmingham, Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The proposed project involves a high-quality randomized controlled (RCT) design that examines the effects of a remotely-delivered, racially-tailored exercise training program for immediate and sustained improvement in walking dysfunction, symptoms, and health-related quality of life (HRQOL) among African-Americans with MS residing in rural environments. The primary analysis will test the hypothesis that those who are randomly assigned into the intervention condition (i.e., exercise training) will demonstrate (a) improvements in outcomes from baseline that (b) are sustained over 4-months of follow-up compared with those in the control condition (i.e., stretching).
Detailed Description
There is a lack of evidence from high-quality randomized controlled trials (RCTs) of exercise training for African-Americans with multiple sclerosis (MS), as only 1.7% of participants in physical activity and exercise research involving persons with MS identify as African-American. The population of African-Americans with MS deserves equal and focal research that addresses the unique challenges of MS in the African-American rural residing community. We uniquely address this population with a highly-developed and refined exercise training program that is racially-tailored for the target population. We further provide a highly-developed and refined exercise training program that can be undertaken in one's home and/or local community, and does not require facility access that is extremely limited in the target, rural residing population of persons with MS. The program is further tailored based on qualitative research and addresses the unique needs of the African-American community with MS. There is no other research program this advanced in study refinement and design for immediate integration into a high-quality RCT for changing the lives of African-Americans with MS who reside in rural communities of the Southeastern portion of the United States. If successful, the study, as designed, will provide Class I evidence that is necessary for immediate implementation after trial completion through insurance providers and healthcare providers, including physical therapists, rehabilitation practitioners, and community health workers/providers. This program further aligns with recently developed and highly-refined conceptual and practice models for implementation of exercise into the care of persons with MS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Rural, Walking dysfunction, Health-Related Quality of Life, African-American

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Guidelines for Exercise in Multiple Sclerosis (GEMS)
Arm Type
Experimental
Arm Description
Participants in this condition will receive a 4-month home-based, remotely supported aerobic and resistance exercise program based on the Guidelines for Exercise in Multiple Sclerosis (GEMS).
Arm Title
FLEX Stretching and Toning Program
Arm Type
Sham Comparator
Arm Description
Participants in this condition will receive a 4-month home-based, remotely supported stretching program emphasizing flexibility and range of motion as important components of fitness based on Stretching for People with MS: An Illustrated Manual from the National MS Society.
Intervention Type
Behavioral
Intervention Name(s)
Guidelines for Exercise in Multiple Sclerosis (GEMS)
Intervention Description
Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on aerobic fitness and muscle strength as a mode of training.
Intervention Type
Behavioral
Intervention Name(s)
FLEX Stretching and Toning Program
Intervention Description
Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on stretching and range of motion as the mode of training.
Primary Outcome Measure Information:
Title
Walking Dysfunction
Description
Multiple Sclerosis Walking Scale-12 (MSWS-12); scores range between 0 (min) and 100 (max), higher scores reflect greater walking problems.
Time Frame
Changes in walking scores from Baseline, 4-months, and 8-months.
Secondary Outcome Measure Information:
Title
Disability
Description
Patient Determined Disease Steps (PDDS) scale; scores range between 0 (min) and 8 (max), higher score reflect greater perceived disability.
Time Frame
Changes in disability scores from Baseline, 4-months, and 8 months.
Title
Fatigue Severity
Description
Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity.
Time Frame
Changes in fatigue from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
Title
Depressive Symptoms
Description
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.
Time Frame
Changes in depressive symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
Title
Anxiety
Description
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.
Time Frame
Changes in anxiety symptoms from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
Title
Health-related Quality of Life (HRQOL)
Description
Multiple Sclerosis Impact Scale (MSIS-29); scores range between 0 (min) and 100 (max), higher scores indicate greater impact of disease on daily function (i.e. worse outcomes).
Time Frame
Changes in quality of life from Baseline, after 4-month intervention period, and 4 months after intervention cessation.
Other Pre-specified Outcome Measures:
Title
Exercise Behavior
Description
Godin Leisure Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in exercise behavior.
Time Frame
Changes in exercise behavior from Baseline, after 4-month intervention period, and 4 months after intervention cessation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English as primary language Identify as African-American or Black Age of 18 years or older Diagnosis of MS Relapse free in the past 30 days Internet and email access Willingness to complete the outcome questionnaires Willingness to undergo randomization Insufficient physical activity (not meeting current physical activity guidelines based on GLTEQ) Mild-moderate ambulatory disability (MSWS-12 score between 25-49 & PDDS score between 2-4) Exclusion Criteria: Individuals not meeting above inclusion criteria Individuals with moderate to high risk for contraindications of possible injury or death when undertaking strenuous or maximal exercise (PARQ).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert W Motl, PhD
Phone
205-975-1306
Email
robmotl@uic.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Edson Flores, MPH
Phone
312-413-4967
Email
eflore42@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert W Motl, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert W Motl, PhD
Phone
205-975-1306
Email
robmotl@uic.edu
First Name & Middle Initial & Last Name & Degree
Edson Flores, MPH
Phone
312-413-4967
Email
eflore42@uic.edu
First Name & Middle Initial & Last Name & Degree
Robert W Motl, PhD
First Name & Middle Initial & Last Name & Degree
Edson Flores, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Examining the Effects of a Remotely-delivered, Racially-tailored Exercise Training Program for Immediate and Sustained Improvements in Walking Dysfunction, Symptoms, and Health-related Quality of Life (HRQOL) Among African-Americans With Multiple Sclerosis (MS) Residing in Rural Environments.

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