E-Based Physical Exercise in Patients With Multiple Sclerosis and Comorbidity

NCT06298201 | Recruiting

• 1 other identifier: IMAGINE2024
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Physical exercise (PE) improves symptoms and quality of life in patients with multiple sclerosis (pwMS). Comorbidity is prevalent among pwMS and may contribute to disease progression. Integrating and sustaining PE is challenging and E-based PE solutions have been proposed as a tool to support the integration of PE into daily life. Aims: To assess the effect of e-based PE in addition to usual care in pwMS on clinical outcome and the levels of inflammatory, metabolic, and neurodegenerative mediators. Furthermore, to determine whether PE plays a role in the modification of comorbidities with a focus on vascular comorbidity and related risk factors, i.e., type 2 diabetes mellitus. Method: This study will be prospective with longitudinal follow-up of pwMS with and without comorbidities. The physical activity of pwMS will be measured at baseline and after six months by accelerometers. In a randomized controlled trial (RCT) patients will be randomly assigned in a 1:1 ratio to receive either usual care or usual care plus an e-based PE program. The exercise program consists of resistance training with resistance bands targeting the lower extremities, including leg press, knee extension, hip flexion, hamstring curl, and hip extension. The sessions will enable participants to engage in group exercises from their homes through a secure online platform, supervised virtually by physiotherapists. The primary endpoints are walking capacity using the 6-meter walk test and the NEDA-3 scale, focusing on the absence of clinical relapses and disease progression, as indicated by an increase in the Expanded Disability Status Scale score and the absence of new disease activity on MRI (including new T2 lesions or enhancing lesions). Secondary outcomes will encompass measures of quality of life and fatigue, as well as levels of potential biomarkers like neurofilament light chain in blood and cerebrospinal fluid. Conclusion: This study will contribute to the rehabilitation and improved quality of life of pwMS particularly of patients with comorbidities. The potential for e-based PE at home to encourage sustained exercise engagement among pwMS will be evaluated, offering a significant contribution to the field of digital healthcare solutions.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; Comorbidity; physical exercise; e-Based

Outcome Measures

Primary Outcomes (2)

• 6-meters' walk test

  Walking capacity, assessed by the 6-meters' walk test

  baseline, 6, 12, and 24 months

• "no evidence of disease activity" (NEDA-3) score

  The "no evidence of disease activity" (NEDA-3) score, which is characterized by three parameters, lack of clinical relapses and disease progression measured by EDSS and absence of new disease activity on MRI (new T2 lesions/enhancing lesion)

  over a two years period of observation time

Secondary Outcomes (3)

• Cognitive function, evaluated using the Montreal Cognitive Assessment (MoCA),

  baseline, 6, 12, and 24 months

• Fatigue levels, assessed using the short-form Neuro-QOL Fatigue Scale

  baseline, 6, 12, and 24 months

• Neurofilament Light Chain (NfL) determination

  baseline, 6, 12, and 24 months

Study Arms (2)

E-Based Physical Exercise Intervention

EXPERIMENTAL

A randomized controlled trial (RCT) aimed at evaluating the effects of an e-based PE intervention at home in addition to conventional PE on the disability progression of pwMS comorbid conditions.

Other: E-Based Physical Exercise Intervention

Conventional Physical Exercise

NO INTERVENTION

Conventional Physical Exercise will receive no e-based PE intervention

Interventions

E-Based Physical Exercise Intervention OTHER

The intervention comprises a 6-months home-based resistance training for the lower extremities, conducted twice weekly.

E-Based Physical Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed MS diagnosis as per the 2017 MS criteria. \[3\]
• Expanded Disability Status Scale (EDSS) assessment score of less than 7.0 at baseline.
• Adults aged 18 years or above.
• Commitment and mental ability to participate in a 6-month e-based physical exercise program, supervised bi-weekly by a physiotherapist.

You may not qualify if:

• \. Change in prophylactic DMT within the last 3 months 6. Steroid treatment in the past month. 7. Drug or alcohol abuse. 8. Pregnancy. 9. Active systemic infection

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (2)

University of Southern Denmark

Odense, 5000, Denmark

ENROLLING BY INVITATION

University of Southern Denmark

Odense, 5230, Denmark

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Nasrin Asgari, Professor

  Institute of Regional Health Research, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nasrin Asgari, Professor

CONTACT

+4530700612; nasgari@health.sdu.dk

Ulrik Dalgas, Professor

CONTACT

dalgas@ph.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Due to the nature of the intervention, it is not feasible to blind participants or physiotherapists delivering the program. Nonetheless, to preserve the integrity of the trial, outcome assessors (researchers) will remain blinded to the allocation of treatments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial (RCT) with prospective longitudinal follow up

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 7, 2024
• Study Start: April 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: July 1, 2025
• Last Updated: March 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)