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The Use of Arabic Otago Exercise Program in People With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04818008
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : May 25, 2022
Sponsor:
Information provided by (Responsible Party):
Alia A. Alghwiri, University of Jordan

Brief Summary:

People with multiple sclerosis (MS) need exercise training programs throughout their life in order to prevent secondary complications of the disease. Coronavirus disease of 2019 (COVID-19) forced people with chronic disorders to stay at home in order to prevent the transmission of the virus. Therefore, people with MS now are facing a new challenge in going outside their home to perform their rehabilitation sessions. One of the solutions to keep them exercising is a home-based exercise program and one of the home exercise programs that are well validated in older adults is the Otago exercise program (OEP). Investigators suggest that the balance would improve and fall incidences would reduce using the OEP in people with MS compared to health awareness videos only.

50 participants with confirmed diagnosis of MS will be recruited in both groups. Using a randomized controlled trial this study aims to examine the effectiveness of the OEP compared to a control group that gets health awareness videos only on falls and falls-related factors in people with MS.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Otago Exercise Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Measuring the Effect of Using the Arabic Otago Exercise Program on Falls and Falls-related Factors in People With Multiple Sclerosis
Actual Study Start Date : April 1, 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Otago Exercise Program
Patients will receive the Otago Exercise Program for 8 weeks plus health awareness videos about topics related to MS.
Other: Otago Exercise Program
A Home-based Exercise Program to improve strength and balance and prevent falls.

No Intervention: Control group
Patients will receive health awareness videos only about topics related to MS.



Primary Outcome Measures :
  1. Incidence of falls [ Time Frame: 2 months post intervention. ]
    The effect of the intervention on the incidence of falls.

  2. Incidence of falls [ Time Frame: 6 months post intervention. ]
    The effect of the intervention on the incidence of falls.

  3. Incidence of falls [ Time Frame: 12 months post intervention. ]
    The effect of the intervention on the incidence of falls.


Secondary Outcome Measures :
  1. Fear of Falling (using the Falls Efficacy Scale-International ) [ Time Frame: 2 months post intervention. ]
    The effect of the intervention on fear of falling. The total score ranges between 16 and 64 with a higher score indicates greater fear of falling (worse).

  2. Balance (using Chair balance test and Four test balance scale) [ Time Frame: 2 months post intervention. ]
    The effect of the intervention on balance. The time taken to conduct these balance tasks are timed using a stopwatch. The longer the time taken by the patient to perform the tasks, the worse the balance. There is no minimum or maximum scores for these tests.

  3. Mobility (using Timed-Up and go) [ Time Frame: 2 months post intervention. ]
    The effect of the intervention on mobility. This assessments of mobility is timed out using a stopwatch.

  4. Quadriceps strength (using a dynamometer) [ Time Frame: 2 months post intervention. ]
    The effect of the intervention on quadriceps strength. The strength of quadriceps will be assessed using a dynamometer in kilograms.

  5. The severity of fatigue (using Modified Fatigue Impact Scale) [ Time Frame: 2 months post intervention. ]
    The effect of the intervention on the severity of fatigue. The total score ranges from 0 to 84 with a higher score indicates greater severity of fatigue symptoms (worse).

  6. the Quality of sleep (Using Pittsburgh Sleep Quality Index) [ Time Frame: 2 months post intervention. ]
    The effect of the intervention on the Quality of sleep. The total score ranges from 0 to 21 with a higher score indicates poor quality of sleep (worse).

  7. the severity of Anxiety and Depression (using Hospital Anxiety and Depression Scale) [ Time Frame: 2 months post intervention. ]
    The effect of the intervention on the severity of Anxiety and Depression. The total score for each subscale of the HADS ranges from 0 to 21 with higher score indicates more severe anxiety or depression (worse).

  8. The Quality of Life (using Medical Outcomes Study Short Form 12) [ Time Frame: 2 months post intervention. ]
    The effect of the intervention on Quality of Life. The total score ranges between 0% to 100% with higher score indicates a better quality of life (better).

  9. Cognitive ability (using Montreal Cognitive Assessment) [ Time Frame: 2 months post intervention. ]
    The effect of the intervention on Cognitive ability. The total score ranges from 0 to 30 points with a score of 25 or less indicating cognitive impairment (worse).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of 18 years and older.
  2. Both genders
  3. All types of multiple sclerosis.
  4. Independent in ambulation even with the use of an assistive device.
  5. An Expanded Disability Status Scale (EDSS) score ≤ 6.5.

Exclusion Criteria:

  1. The diagnosis of other neurological or musculoskeletal disorders that affect balance.
  2. If the patient had a relapse within that last four weeks.
  3. wheelchair users.
  4. If the patient is engaged in any exercise program.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04818008


Contacts
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Contact: Alia A Alghwiri, PhD +962798525162 a.ghwiri@ju.edu.jo
Contact: Jennifer A Muhaidat, PhD j.muhaidat@ju.edu.jo

Locations
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Jordan
University of Jordan Recruiting
Amman, Jordan, 11942
Contact: Alia A. Alghwiri    0798525162    ALIA.ALGHWIRI@GMAIL.COM   
University of Jordan Recruiting
Amman, Jordan, 11942
Contact: Alia Alghwiri, PhD    0777665737    a.ghwiri@ju.edu.jo   
Sponsors and Collaborators
University of Jordan
Investigators
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Principal Investigator: Alia A Alghwiri University of Jordan
  Study Documents (Full-Text)

Documents provided by Alia A. Alghwiri, University of Jordan:
Statistical Analysis Plan  [PDF] March 23, 2021

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Responsible Party: Alia A. Alghwiri, Professor, University of Jordan
ClinicalTrials.gov Identifier: NCT04818008    
Other Study ID Numbers: "11-2021"
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: May 25, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alia A. Alghwiri, University of Jordan:
Otago Exercise Program
Falls
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases