NCT06374108

Brief Summary

The goal of the present study is to investigate effects of progressive resistance training on central nervous system functioning (corticospinal excitability (CSE)) and walking capacity in persons with multiple sclerosis (pwMS). A total of 54 pwMS will be enrolled and randomized into 1 of 3 groups: high dose resistant training (RT), low dose RT, and waitlist control.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
0mo left

Started May 2024

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
May 2024May 2026

First Submitted

Initial submission to the registry

April 16, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

1.7 years

First QC Date

April 16, 2024

Last Update Submit

December 6, 2024

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • MEP/Mmax ratio

    Cortical excitability measured as amplitude percentage ratio between MEP (resting) and Mmax (Cmap of TA). Unit (intended): %

    Change from Baseline to 10 weeks

Secondary Outcomes (31)

  • Muscle strength

    Change from Baseline to 10 weeks

  • Voluntary activation I

    Change from Baseline to 10 weeks

  • Voluntary activation II

    Change from Baseline to 10 weeks

  • Force Steadiness

    Change from Baseline to 10 weeks

  • Rate of Force Developement

    Change from Baseline to 10 weeks

  • +26 more secondary outcomes

Study Arms (3)

High dose resistance training

ACTIVE COMPARATOR

10 weeks intervention with 2.5 weekly supervised resistance training sessions (2 or 3 sessions/week for high dose resistance training; 25 sessions in total).

Behavioral: Progressive resistance training

Low dose resistance training

ACTIVE COMPARATOR

10 weeks intervention with 1 weekly supervised resistance training session (low dose resistance training; 10 sessions in total).

Behavioral: Progressive resistance training

Waitlist control.

NO INTERVENTION

The waitlist control group will initially be instructed to maintain their normal daily activity during the 10 week intervention period. Hereafter, they will be offered a 10 week high dose resistance training intervention that combines supervised and home based exercise sessions .

Interventions

Progressive resistance trainingBEHAVIORAL

The RT exercise regime will focus on lower extremity exercises (60-90% of 1 repetition maximum) as well as incorporating functional exercises.

High dose resistance trainingLow dose resistance training

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • MS diagnosis according to the McDonald diagnostic criteria
  • Shows impairments in walking capacity
  • Ability to self transport to test and exercise

You may not qualify if:

  • Pregnancy
  • Neurological or other comorbidities that affects the nervous system
  • Relapse within the past 2 months
  • Pacemaker or metallic implants
  • Hypertension (medically unregulated)
  • Participation in structured RT over the past 3 months (≥ 2 sessions/week).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Public Health

Aarhus, Central Jutland, 8000, Denmark

RECRUITING

Department of Nutrition, Exercise and Sports, University of Copenhagen

Copenhagen, Copenhagen N, 2200, Denmark

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lars Hvid, PhD

CONTACT

93508717lhvid@ph.au.dk

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
SPONSOR

Study Record Dates

First Submitted

April 16, 2024

First Posted

April 18, 2024

Study Start

May 1, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

May 31, 2026

Last Updated

December 11, 2024

Record last verified: 2024-12

Locations

DK(2)