Multimodal Exercise Training to Reduce Frailty in People With Multiple Sclerosis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06042244

Enrollment

Registered

2023-09-18

Start date

2023-11-20

Completion date

2025-02-23

Last updated

2025-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Multiple Sclerosis

Brief summary

Study Significance: This proposed investigation is designed to examine the feasibility of an exercise-based intervention to reduce frailty in people living with MS. The proposed research will be the first to establish the feasibility of targeting frailty in pwMS and will begin to examine the dynamic nature of frailty in MS. These advances will pave the way for planned prospective studies toward effective targets for diagnostics, and rehabilitation of frailty in MS.

Interventions

OTHERMultimodal Exercise Group

Listed in arm/ group descriptions

OTHERWaitlist

listed in arm/group description

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Subjects must be aged 40-65 years old to be enrolled in this study. * Subjects must meet 3 of 5 frailty criteria (weight loss; exhaustion; weakness; slowness; inactivity) to be considered. * Subjects must have a confirmed diagnosis of MS by the treating neurologist * be free from MS relapses in the last 30 days * have an Expanded Disability Status Scale (EDSS) score ≤ 6.0 * be fluent in spoken and written English.

Exclusion criteria

* unable to walk unassisted for at least ten meters * are diagnosed with other clinically important neurological conditions (such as Parkinson's Disease, epilepsy, etc.) * exhibit severe cognitive impairment (as determined by a Mini-Cog score \<3) * are diagnosed with active psychiatric problems. * unstable cardiovascular conditions (e.g., malignant arrhythmias, critical mitral stenosis, clinically severe left ventricular outflow obstruction, critical proximal coronary artery stenosis) * arthritis of the lower limbs * acute lower back or lower limbs pain * rheumatic and/or severe orthopedic problems that may interfere with resistance training.

Design outcomes

Primary

Measure	Time frame	Description
Primary Outcome	6 weeks	Preliminary efficacy of multimodal exercise in improving frailty \[Time frame: The EFIP outcome will be assessed at baseline and at 6-weeks post-intervention\] Frailty will be evaluated through the Evaluative Frailty Index for Physical Activity (EFIP).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026