Skeletal Muscle Aging and Responsiveness in Aged People With MS

RecruitingNot a drug-phase studyMS (type not specified)NCT07500727

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Exercise trial consisting of both cardiovascular and strength training

What it measured

Main measures

  • fMQ

    Week -3 and Week -2

    Physical function
  • CRF

    Enrollment to end of study at 18 weeks

Other measures (18)

  • Total and Regional Body Composition

    Week -3 and Week -2

    Blood or spinal fluid markersPhysical function
  • Muscle Biopsy

    Week 1 and Week 12 Muscle Biopsy

  • Skeletal Muscle Phenotyping

    Week 0, 6, and 12

    Vision
  • Systemic Inflammation

    Week 1 and Week 12

    Blood or spinal fluid markersImmune response
  • Muscle Inflammation

    Week 1 and Week 12

    Immune response
  • Blood Biomarkers

    Week 1 and Week 12

    Blood or spinal fluid markers
  • Mobility and Balance

    Week -3 and Week -2

    Walking and mobility
  • Basic Cognitive Function and Balance

    Week -3 and Week -2

    Thinking and memoryWalking and mobility
  • Participant's Self Evaluation of Physical, Mental, and Social Health

    Week -3 and Week -2

    PainQuality of life (reported by participants)
  • Depression

    Week -3 and Week -2

    Mood and sleep

Who could take part

MS (type not specified) · 60 and over · EDSS 2 to 5.5

Show the full criteria

Inclusion criteria

* 1. Male or female aged 60 or above 2. Free of unmanaged chronic diseases other than multiple sclerosis 3. No structured exercise program (2 or more bouts/wk) within previous 6 months 4. Cognitively capable of providing informed consent 5. Must meet EDSS score between 2 to 5.5 during screening

Exclusion criteria

* 1. Neuromuscular or musculoskeletal disorder, other than multiple sclerosis, that would limit the ability to perform the exercise and/or testing bouts. 2. Cardiopulmonary disorders or reduced breathing capacity 3. Metabolic diseases including markers of liver disease (ALT > 52 U/dl) and type 2 diabetes (HbA1C ≥ 6.5, fasting blood glucose ≥ 126 mg/dl) 4. Taking any dose of metformin 5. Any other disease or disorder that would influence exercise response (e.g., chronic kidney disease, Alzheimer's, current cancer diagnosis or within 2 yr remission, cerebrovascular) 6. History of Chemotherapy within 5 years 7. Unchangeable anticoagulant (Coumadin, Pradaxa, etc.) use. To be determined by clinical staff. 8. Insulin sensitizing/blood glucose lowering (e.g., metformin) or metabolic (GLP1 agonists) drugs. 9. High dose statin (40 mg and above) 10. Have a non-correctable visual impairment 11. Score less than 29 on the Symbol Digit Test 12. Received Botox for spasticity within the prior 3 months of study participation. 13. Cannot have any adjustments to Baclofen during study participation. 13. Unable to commit to \~4 months required to complete the study. 14. Lidocaine allergy 15. Tobacco use 16. Excessive alcohol consumption (3 drinks/d or 7 drinks/wk for females; 4 drinks/day or drinks/wk for males) 17. BMI greater than 35.0 kg/m2

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

The purposes of this study are to: 1) compare baseline muscle and cardiovascular health in older individuals (>60 years old) diagnosed with MS to age-matched people without MS, 2) determine muscle and whole body changes to an exercise training program, 3) determine if the muscle in a more affected leg in individuals diagnosed with MS is different from the muscle of a less affected leg, and 4) if or how individuals diagnosed with MS adapt differently than age-matched people without MS to exercise training. Participation in this study will average 1.5 hours per visit, 3 visits per week, for approximately 4 months.

Papers

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History

    1. Started

      Mar 2026

    2. Main results due

      Dec 2026

    3. Finished

      Dec 2026

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