The Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in the general population and with individuals living with chronic conditions. Raw scores were converted to T-scores (using an adult referent population) ranging from 0-100 with a mean of 50 and standard deviation (SD) of 10 in the referent population. For the PROMIS-29 symptom-related domains (anxiety, depression, fatigue, sleep disturbance, and pain interference), higher scores represent greater symptom burden (worse functi
The MFIS is a 21-item self-reported measure of how fatigue impacts the lives of persons with multiple sclerosis. This instrument provides an assessment of the effects of fatigue as it relates to physical, cognitive, and psychosocial functioning. Participants rate on a 5-point Likert scale, with 0 = 'Never' to 4 = 'Almost always' their agreement with 21 statements. Total score (0-84) and subscales for physical (0-36), cognitive (0-40) and psychosocial functioning (0-8). Higher numbers indicate greater fatigue in all domains.
Assessment examining processing speed using an tablet-based measure developed to closely resemble the symbol digit modalities test. Participants match symbols to digits over a 2-minute trial. The number of correct matches represents the score, with higher correct matches indicative of better processing speed performance. The low range of possible scoring is 0 with no upper range limit. In a study by Rao and colleagues (2017), persons with MS scored and average of 51.1 (+/- 11.9) on the first trial and 52.8 (+/- 2.0) on the second trial. One trial was conducted in this study.
Processing speed test total correct at baseline
Group
Value
95% CI
Forced Aerobic Exercise (FE)
43.0
± 8.0
Voluntary Exercise
55.3
± 8.5
Processing speed test total correct at EOT
Group
Value
95% CI
Forced Aerobic Exercise (FE)
45.1
± 9.4
Voluntary Exercise
57.4
± 9.8
To Investigate the Role of Klotho in Promoting Neuroprotection.Secondary· Week 1 (exercise session 1), Week 12 (exercise session 24)
Laboratory Assessment: Blood draws will be conducted at 4 different points in time to determine the acute and long-term change in serum Klotho; at week one session one, pre- and post-exercise, and at the last session12-week exercise intervention, pre- and post-exercise.
Klotho (Baseline Pre-Exercise)
Group
Value
95% CI
Forced Aerobic Exercise (FE)
1273.3
± 787.7
Voluntary Aerobic Exercise (VE)
1100.4
± 878.0
Klotho (Baseline Post-Exercise)
Group
Value
95% CI
Forced Aerobic Exercise (FE)
929.5
± 661.1
Voluntary Aerobic Exercise (VE)
1166.4
± 745.4
Klotho (Final Session pre-exercise)
Group
Value
95% CI
Forced Aerobic Exercise (FE)
948.3
± 550.2
Voluntary Aerobic Exercise (VE)
1019.4
± 608.7
Klotho (Final Session post-exercise)
Group
Value
95% CI
Forced Aerobic Exercise (FE)
1265.8
± 940.2
Voluntary Aerobic Exercise (VE)
154.4
± 1104.1
Neurofilament light (Baseline)
Group
Value
95% CI
Forced Aerobic Exercise (FE)
14.6
± 7.5
Voluntary Aerobic Exercise (VE)
14.5
± 7.3
Neurofilament light (Final Session)
Group
Value
95% CI
Forced Aerobic Exercise (FE)
16.5
± 6.4
Voluntary Aerobic Exercise (VE)
15.0
± 4.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse experiences were collected up to 19 weeks from start to completion of the study..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This project will investigate the feasibility and initial efficacy of two aerobic exercise training approaches, forced and voluntary, to improve motor function in persons with multiple sclerosis (MS). We hypothesize that intensive aerobic exercise training elicits a neurorepairative and neurorestorative response on the central nervous system, which may improve motor function as it relates to gait and mobility. Should aerobic cycling, forced or voluntary, improve gait and functional mobility in persons with MS, it would serve as a new model to restoring function, rather than current models that focus on compensation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by The Cleveland Clinic
Last refreshed: 6 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04906057.