Recruiting

Exercise Training

Sponsor:

Oklahoma Medical Research Foundation

Code:

NCT07500727

Conditions

Multiple Sclerosis

Aging

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Exercise trial consisting of both cardiovascular and strength training

Study Details

Brief summary:

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.

Conditions

Multiple Sclerosis

Aging

Study ID

NCT07500727

Start date

Mar 6, 2026

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: People with MS

People with MS, 60 or older

Interventions

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 measure

  • fMQ [ Time Frame: Week -3 and Week -2 ]
  • CRF [ Time Frame: Enrollment to end of study at 18 weeks ]

Central Contacts and Locations

Central contacts

Lena Fuentes

4052717745lena-fuentes@omrf.org

Bobbette Miller

4052714214bobbette-miller@ou.edu

Locations

Oklahoma Medical Research Foundation

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Lena Fuentes

4052717745lena-fuentes@omrf.org

More Information

Sponsor

Oklahoma Medical Research Foundation

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • exercise
  • skeletal muscle
  • metabolism
  • muscle
  • resistance training
  • training
  • cardiovascular training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oklahoma Medical Research Foundation on 2026-03-30.