An interventional study of Exercise trial consisting of both cardiovascular and strength training in Multiple Sclerosis and Aging, sponsored by Oklahoma Medical Research Foundation. Recruiting at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Oklahoma Medical Research Foundation · Not applicable, Interventional, and Other
Among 1,192 studies in Multiple Sclerosis with a site in United States — 185 open to participants now, 261 under way, 23 of them phase 3. Multiple Sclerosis · United States.
Among the 1,192 studies in Multiple Sclerosis with a site in United States, this one is the 779th largest by planned enrollment of the 879 interventional ones, is one of 44 that started in 2026, is one of 381 with no phase, reaches primary completion later than 74 of the 257 other live ones, and was the 1,154th registered.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 10 is below the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →185 of the 1,192 studies in Multiple Sclerosis with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
The full table on the hub →1,192 studies; the count open now beside each. This study's row is marked.
First in 1976; this study’s year is marked. 44 started in 2026.
Median enrollment 50 across the 879 interventional studies, 100 across the 302 observational. Of the 817 that completed or were terminated, 331 (41%) have results posted.
376 of 1,192 have an industry lead sponsor. The 10 most frequent:
Oklahoma Medical Research Foundation is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
Oklahoma Medical Research Foundation has 1 study filed under Multiple Sclerosis — fewer than ten, so there is no comparison to draw.
80 of the studies in Multiple Sclerosis with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05134441Phase 3Immunic AGStudy to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis | 2026-11 |
| NCT06847724Phase 3SandozComparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis | 2026-11 |
| NCT05877963Phase 3TG Therapeutics, Inc.Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab | 2027-01-21 |
| NCT06136728Phase 3MGH Institute of Health ProfessionsDalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis | 2027-05 |
| NCT06141473Phase 3SanofiEfficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis | 2027-05-06 |
Among the 1,192 studies in Multiple Sclerosis with a site in United States, from their registry updates:
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.
Disease-modifying therapies (DMT) are effective in reducing the risk of developing additional debilitating symptoms of multiple sclerosis (MS) and slowing disease progression, leading to better functional mobility outcomes and quality of life. As a result, people with MS (PwMS) are now more likely to maintain independence into their later years. Since older PwMS maintaining independence is a relatively recent phenomenon, there is virtually nothing known about how MS exacerbates the age-related loss of muscle mass and function (i.e., sarcopenia) or how PwMS adapt to interventions, such as exercise, that slow age-related declines. In addition, PwMS are known to be highly heterogeneous in functional ability, fatigue, and other physical factors. The investigators do not yet understand the aging trajectory in PwMS and if current treatment guidelines for aged individuals for overall health, including maintaining muscle mass and function, are effective in aged PwMS.
Aging-related functional declines are thought to be caused by hallmark biological processes that ultimately manifest in physical, mental, and metabolic impairments, which compromise healthspan and quality of life. Exercise is a multipotent treatment with promise to mitigate most aging hallmarks. However, there is substantial variability in how individuals respond to exercise training, which is termed inter-individual response heterogeneity (IRH). Low cardiorespiratory fitness (CRF, VO2max) and low functional muscle quality (fMQ; strength/muscle mass) are multi-system manifestations of the deterioration of the cellular hallmarks of aging, but both CRF and fMQ are modifiable with endurance exercise training (ET) and resistance exercise training (RT). It is yet to be determined how the hallmarks of aging influence IRH. For example, poor responder status could be caused by hallmark deterioration of mitochondrial function, ability to maintain proteostasis, or systemic inflammation.
The investigators are conducting an NIH funded clinical trial that hypothesizes that factors central to aging itself, such as proteostasis, mitochondrial energetics, and inflammation, are contributors to the multidimensional circuitry that determines whether an individual achieves the minimum clinically important difference (MCID) in CRF and/or fMQ with exercise training. The goal of the funded trial is to disentangle the complicated relationships between endogenous and exogenous factors that drive response variation to exercise. To accomplish this goal, investigators will use tissue (muscle and blood) sampling, multi-omics, extensive phenotyping, and multidimensional modeling. For the PHF proposal, investigators will leverage this ongoing clinical trial and enroll aged PwMS into the study. The overall goal of the current proposal is to establish baseline muscle and overall health characteristics, responsiveness to exercise training, and factors that give rise to heterogeneity of symptomology in aged PwMS.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 ( > 52 U/dl) and type 2 diabetes ( ≥ 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. greater than 35.0 kg/m2
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
People with MS, 60 or older
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.
Also known as: endurance, strength
fMQ
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.
Time frame: Week -3 and Week -2
CRF
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
Time frame: Enrollment to end of study at 18 weeks
Total and Regional Body Composition
Additional clinical phenotyping includes total and regional body composition scans using a GE Lunar iDXA and insulin resistance by HOMA-IR from fasting blood draws obtained from a study phlebotomist. An Octave biomarker panel will also be evaluated from blood draws.
Time frame: Week -3 and Week -2
Muscle Biopsy
Investigators will use established methods to assess hallmarks of aging. Investigators will assess proteostasis in skeletal muscle using the final muscle biopsy sample from each leg with tracer-based proteomics. Investigators will use high-resolution respirometry on skeletal muscle mitochondria (Oroboros O2K respirometers) to determine both mitochondrial respiratory function and reactive oxygen species generation.
Time frame: Week 1 and Week 12 Muscle Biopsy
Skeletal Muscle Phenotyping
For additional skeletal muscle phenotyping, investigators will perform histological analyses of skeletal muscle with immunohistochemical approaches using the well-established methods for cellular morphology, myofiber type distribution and size heterogeneity, fibrosis, vascularization (capillary supply), senescence/DNA damage, the presence of resident stem cells, and inflammatory cells including M1 macrophages10-12. Image analysis will be performed using the automated workflow in MyoVision.
Time frame: Week 0, 6, and 12
Systemic Inflammation
Systemic inflammation will be assessed in serum samples using the MSD 10-plex cytokine panel. The cytokines tested, GM-CSF, IL-1alpha, IL-5, IL-7, IL-12, IL-15, IL-16, IL-17A, TNF-beta, and VEGF-A each have dynamic detection ranges respectively, 0.16-750 pg/mL, 0.09-278 pg/mL, 0.14-562 pg/mL, 0.12-563 pg/mL, 0.33-2,250 pg/mL, 0.15-525 pg/mL, 2.83-1,870 pg/mL, 0.31-3,650 pg/mL, 0.08-458 pg/mL, and1.12-562 pg/mL. Increased cytokines (high pg/mL) indicates a more active, heightened immune response with low cytokines (low pg/mL) indicating a normal resting immune system state.
Time frame: Week 1 and Week 12
Muscle Inflammation
Investigators will also assess muscle inflammation in a targeted manner based on the fold change in expression of 3 receptors (TNFα, Fn14, IL-6) and associated intracellular signaling (p-STAT3, NFKB p-p65).
Time frame: Week 1 and Week 12
Blood Biomarkers
Investigators also evaluate biomarkers in the blood using the Octave biomarker panel, a panel that measures 18 biomarkers to assess disease level in PwMS. Each biomarker generates an overall activity (DA) score from 1.0 to 10.0. Low DA score indicates more controlled, lower inflammation. A high DA score indicates high inflammation.
Time frame: Week 1 and Week 12
Mobility and Balance
Mobility and balance testing will be accomplished via the well-established short physical performance battery (SPPB). The scale is a minimum score of 0 and maximum score of 12 with higher scores indicating better lower extremity function.
Time frame: Week -3 and Week -2
Basic Cognitive Function and Balance
Investigators will assess basic cognitive function (reaction time, impulse control, visual processing speed) and balance with the Sway platform (Sway Medical). A score of 100 indicates perfect stability and lower scores indicate instability with the lowest score being 0.
Time frame: Week -3 and Week -2
Participant's Self Evaluation of Physical, Mental, and Social Health
Investigators will use the validated Patient-Reported Outcomes Measurement Information System (PROMIS) mental health battery to evaluate participant's perspective on physical, mental, and social health. This test uses a T-score metric (typical range of 20-80) with a mean of 50, and a standard deviation of 10, higher scores indicating higher levels of metric measured with a maximum of \>70 indicating severe for negative domains like pain, and scores minimum of \<55 being within normal limits/absent of negative domain.
Time frame: Week -3 and Week -2
Depression
Beck Depression Inventory II will be used to assess the presence and severity of depression symptoms within the past 2 weeks. Minimum score is 0 which indicates no presence of depression, and 63 being the highest score indicating the presence of severe depression.
Time frame: Week -3 and Week -2
Circadian Rhythm
Circadian rhythm will be assessed using the Morningness-Eveningness Questionnaire. Minimum score of 16 indicates evening preference and highest score of 86 indicates morning preference.
Time frame: Week -3 and Week -2
Sleep Quality
Pittsburgh Sleep Quality Index is a self-reported questionnaire that will be used to evaluate participant's sleep quality. 0 being the lowest score and 21 being the highest, with higher scores indicating poorer sleep quality.
Time frame: Week -3 and Week -2
Fatigue
Fatigue will be evaluated using the Modified Fatigue Impact Scale (MFIS) questionnaire to rate fatigue in three categories: physical, cognitive, and psychosocial. A total score ranging from 0 to 84, where higher scores indicate greater fatigue impacting daily life.
Time frame: Week -3 and Week -2
Gait Speed
A 10 Metre Walk Test will be administered to evaluate participant's gait speed and functional mobility. The total time taken to walk 10 meters is recorded, with slower speed indicating fall risks and higher speeds indicating better mobility.
Time frame: Week -3 and Week -2
Functional Capacity
The 6 Minute Walk Test will be used to evaluate functional capacity, and measures the distance a participant can walk in 6 minutes. Longer distance covered indicates stronger gross functional capacity.
Time frame: Week -3 and Week -2
Phenotyping Support with Multidimensional Interindividual Response Heterogeneity
To strengthen the phenotyping to support the multidimensional Interindividual Response Heterogeneity circuitry, investigators will use the Oura ring to monitor activity, sleep, mobility, temperature trends, and additional vital signs.
Time frame: Week 1 through Week 13
Glucose Monitoring
To strengthen the phenotyping to support the multidimensional Interindividual Response Heterogeneity circuitry, subjects will wear a continuous glucose monitor (CGM) for \~7 d durations using the Dexcom G8 at the beginning and end of exercise training.
Time frame: Week 1 and Week 12
Dietary Intake
Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool will be used to evaluate participant's dietary intake.
Time frame: Week -3 to -2, Week 0, Week 6, and Week 12
Blood Biomarkers
Investigators also evaluate biomarkers in the blood using the Octave biomarker panel, a panel that measures 18 biomarkers to assess disease level in PwMS. To assess inter-tissue communication, investigators will perform plasma EV long and small RNA-Seq, and whole muscle RNA-Seq and ATAC-Seq. All samples will be processed, sequenced, and analyzed.
Time frame: Week 1 and Week 12
Plan to share: Undecided — The data will be partially de-identified. IHMC will only have access to the participant's Subject ID, year of birth (and therefore age), and height/weight, which is necessary for normalization of outcomes such as cardiorespiratory fitness (VO2max testing).
Start is estimated for Mar 2026; primary completion for Dec 2026, 9 months later.
Of 847 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's planned 9 months is below that.
Counting every sponsor, half of 869 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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Oklahoma Medical Research Foundation