Skeletal Muscle Aging and Responsiveness in Aged People With MS
Recruiting · NCT07500727 · Interventional (participants receive a specific treatment) · Lead sponsor: Oklahoma Medical Research Foundation
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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.
Who can take part
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.
- \. Cardiopulmonary disorders or reduced breathing capacity
- \. Metabolic diseases including markers of liver disease (ALT \> 52 U/dl) and type 2 diabetes (HbA1C ≥ 6.5, fasting blood glucose ≥ 126 mg/dl)
- \. Taking any dose of metformin
- \. 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)
- \. History of Chemotherapy within 5 years
- \. Unchangeable anticoagulant (Coumadin, Pradaxa, etc.) use. To be determined by clinical staff.
- \. Insulin sensitizing/blood glucose lowering (e.g., metformin) or metabolic (GLP1 agonists) drugs.
- \. High dose statin (40 mg and above)
- \. Have a non-correctable visual impairment
- \. Score less than 29 on the Symbol Digit Test
- \. Received Botox for spasticity within the prior 3 months of study participation.
- \. Cannot have any adjustments to Baclofen during study participation.
- \. Unable to commit to \~4 months required to complete the study.
- \. Lidocaine allergy
- \. Tobacco use
- \. Excessive alcohol consumption (3 drinks/d or 7 drinks/wk for females; 4 drinks/day or drinks/wk for males)
- \. BMI greater than 35.0 kg/m2
Where it is running
1 location listed across 1 US state.
- Oklahoma Medical Research Foundation - Oklahoma City, Oklahoma, United States