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Skeletal Muscle Aging and Responsiveness in Aged People With MS

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 5 visits, 3 visits
  • Time periods mentioned: 4 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participation in this study will average 1.5 hours per visit, 3 visits per week, for approximately 4 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at muscle and heart health and how exercise changes the body in adults age 60 or older with and without multiple sclerosis (MS). It also compares the more affected and less affected legs in people with MS. Visits last about 1.5 hours, 3 times a week, for about 4 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 60 or older.
  • Have no long-term diseases that are not under control, other than MS.
  • Have not followed a planned exercise program 2 or more times a week in the past 6 months.
  • Be able to understand the study and agree to join.
  • Have a screening EDSS score of 2 to 5.5. This scale measures disability from MS.

Who can't join

  • Have a nerve, muscle, bone, or joint condition other than MS that limits exercise or testing; or have heart, lung, or breathing problems.
  • Have a disease affecting how the body uses energy, including signs of liver disease (ALT above 52 U/dl) or type 2 diabetes (HbA1C of 6.5 or higher, or fasting blood sugar of 126 mg/dl or higher).
  • Have another illness that could affect exercise results, such as kidney disease, Alzheimer's disease, disease of the brain's blood vessels, current cancer, or cancer in remission for 2 years or less; or have had chemotherapy in the past 5 years.
  • Take metformin, other blood sugar-lowering drugs, GLP-1 drugs, or a statin dose of 40 mg or more; or take blood thinners that clinical staff decide cannot be changed.
  • Have vision problems that cannot be corrected, or score below 29 on the Symbol Digit Test, a thinking-skills test.
  • Have had Botox for muscle stiffness in the past 3 months, need changes to Baclofen during the study, or have an allergy to lidocaine.
  • Use tobacco or drink too much alcohol. The listed limits are 3 drinks a day or 7 a week for women, and 4 a day for men; the weekly limit for men is not given.
  • Cannot commit to about 4 months, or have a body mass index (BMI, a measure based on height and weight) above 35.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

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