NCT07500727 · Oklahoma Medical Research Foundation
Skeletal Muscle Aging and Responsiveness in Aged People With MS
(MS-M3AX)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Exercise trial consisting of both cardiovascular and strength training
All participants will receive 12 weeks of combined ET and RT. All exercise is supervised with a certified trainer. All study staff are CPR trained. Progression of volume and intensity will occur during the ramp-up week and into the first week of training. The ramp-up period increases the number of sets, repetitions, and intensity to limit excessive muscle damage, soreness, and fatigue. Full volume training will be achieved by the end of week one and progression thereafter will be based on intensity. Participants will complete 3x/wk ET and 3x/week RT. Both ET and RT will be progressed on an individual level via monitoring of each session with pragmatic increases in cycling wattage, treadmill speed/grade, and weight lifted as needed. At the completion of training there will be a testing week that repeats the battery of testing completed during the wash-in period to determine responder status by the a priori designated MCIDs for CRF and fMQ.
Primary outcome measures
fMQ
Time frame: Week -3 and Week -2
Investigators will determine fMQ from bilateral one-repetition maximum (1RM) knee extension strength / bilateral thigh lean mass via dual-energy x-ray absorptiometry (DXA). Strength testing will be performed with a study trainer and DXA scanning will occur at Oklahoma Children's Hospital OU Health.
CRF
Time frame: Enrollment to end of study at 18 weeks
Investigators will test CRF on a cycle ergometer using a continuous ramp protocol and ECG monitoring. The study clinician will monitor the ECG during testing while 1-2 other study personnel are administering the test. The ideal ramp for the individual is based on sex, body size, and initial assessments during familiarization
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Oklahoma City, Oklahoma
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Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Data: ClinicalTrials.gov · synced Mar 30, 2026 · Source of record for eligibility and locations