NCT04818008

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

January 28, 2021

Last Update Submit

July 7, 2023

Conditions

Multiple Sclerosis

Keywords

Otago Exercise ProgramFalls

Outcome Measures

Primary Outcomes (3)

  • Incidence of falls

    The effect of the intervention on the incidence of falls.

    2 months post intervention.

  • Incidence of falls

    The effect of the intervention on the incidence of falls.

    6 months post intervention.

  • Incidence of falls

    The effect of the intervention on the incidence of falls.

    12 months post intervention.

Secondary Outcomes (9)

  • Fear of Falling (using the Falls Efficacy Scale-International )

    2 months post intervention.

  • Balance (using Chair balance test and Four test balance scale)

    2 months post intervention.

  • Mobility (using Timed-Up and go)

    2 months post intervention.

  • Quadriceps strength (using a dynamometer)

    2 months post intervention.

  • The severity of fatigue (using Modified Fatigue Impact Scale)

    2 months post intervention.

  • +4 more secondary outcomes

Study Arms (2)

Otago Exercise Program

EXPERIMENTAL

Patients will receive the Otago Exercise Program for 8 weeks plus health awareness videos about topics related to MS.

Other: Otago Exercise Program

Control group

NO INTERVENTION

Patients will receive health awareness videos only about topics related to MS.

Interventions

Otago Exercise ProgramOTHER

A Home-based Exercise Program to improve strength and balance and prevent falls.

Otago Exercise Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jordan

Amman, 11942, Jordan

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Alia A Alghwiri

    University of Jordan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 28, 2021

First Posted

March 26, 2021

Study Start

April 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

JO(1)