Evidence map›Paper›PMID 40912162›Full record

Trial reportMultiple sclerosis and related disorders2025

Safety, adherence, and compliance in a RCT of supervised exercise training among persons with multiple sclerosis who have slowed cognitive processing speed.

Haley Nauman, Grace E Wells, Olesya Iosipchuk, Caroline Rafizadeh, Brendon Truax, Carly Wender, Mary Ann Picone, Krupa Pandey, Ralph H B Benedict, Gary R Cutter and 2 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Multiple sclerosis and related disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Haley NaumanCenter for Neuropsychology and Neuroscience Research, Kessler Foundation, West Orange, NJ, USA.
Grace E WellsCenter for Neuropsychology and Neuroscience Research, Kessler Foundation, West Orange, NJ, USA.
Olesya IosipchukCenter for Neuropsychology and Neuroscience Research, Kessler Foundation, West Orange, NJ, USA.
Caroline RafizadehCenter for Neuropsychology and Neuroscience Research, Kessler Foundation, West Orange, NJ, USA.
Brendon TruaxDepartment of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.
Carly WenderCenter for Neuropsychology and Neuroscience Research, Kessler Foundation, West Orange, NJ, USA.
Mary Ann PiconeHoly Name Multiple Sclerosis Center, Teaneck, NJ, USA.
Krupa PandeyHackensack Meridian Multiple Sclerosis Center, Hackensack, NJ, USA.
Ralph H B BenedictDepartment of Neurology, University of Buffalo, Buffalo, NY, USA.
Gary R CutterDepartment of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.
Robert W MotlDepartment of Kinesiology and Nutrition, University of Illinois Chicago, Chicago, IL, USA.
Brian M SandroffCenter for Neuropsychology and Neuroscience Research, Kessler Foundation, West Orange, NJ, USA; Department of Physical Medicine and Rehabilitation, Rutgers NJ Medical School, Newark, NJ, USA. Electronic address: bsandroff@kesslerfoundation.org.

Funding

CTSA UM1 State University of New York at BuffaloUM1TR005296 · NCATS · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI Sanjay Sethi · 2025 to 2026
$8.3M
Treadmill Walking Exercise Training Effects on Cognition and Brain Function in Multiple Sclerosis: A Systematically-Developed Randomized Controlled TrialR01HD091155 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI SANDROFF, BRIAN M · 2018 to 2022
$1.9M
NCATS NIH HHS UM1 TR005296NICHD NIH HHS R01 HD091155
6 · The paper itself

Abstract

backgroundSafety, adherence, and compliance have been poorly-characterized in randomized controlled trials (RCTs) of exercise training within multiple sclerosis (MS) research. The MoXFo initiative recently proposed standard criteria for defining exercise safety, adherence, and compliance, yet these criteria have infrequently been applied within an exercise training RCT involving people with MS.

objectiveThis study applied published criteria for characterizing safety, adherence, and compliance within a RCT that compared 12-weeks of supervised treadmill walking exercise (TMWX) training (intervention condition) with 12-weeks of stretching-and-toning (active control condition) among fully-ambulatory persons with MS who demonstrated slowed cognitive processing speed (CPS).

methods37 fully-ambulatory persons with MS with slowed CPS were randomly assigned into the TMWX condition (n = 18) or active control condition (n = 19). We defined safety as number of adverse events (AEs); adherence as number and rate of sessions attended; and compliance as number and rate of sessions completed as prescribed. We further examined potential baseline predictors of adherence and compliance rates using correlations and regressions.

resultsThere were 10 non-serious AEs that were generally unrelated to the conditions (e.g., non-injurious falls that took place outside of the study, temporary illnesses). On average, participants attended 25.8 of 36 possible sessions (i.e., adherence rate=71.5 %). On average, participants completed 25.2 of the 36 possible sessions as prescribed (i.e., compliance rate = 70.0 %) and 97.7 % of attended sessions as prescribed. Of note, adherence did not differ by condition, though relative compliance rate was significantly higher among those who underwent the control condition (p = .03). In the overall sample, regressions identified no significant predictors of adherence, but higher agreeableness predicted higher relative compliance rate. Within the TMWX condition, longer disease duration and lower anxiety predicted higher adherence, and lower impact of MS on physical and mental domains and higher agreeableness predicted higher relative compliance rate. Within the control condition, lower brainstem functional systems scores and lower neuroticism predicted higher adherence, and no baseline variables predicted relative compliance rate.

conclusionsThe safety, adherence, and compliance data, as defined based on recent recommendations, suggest that the TMWX and stretching conditions are safe, feasible, and attainable among fully-ambulatory, persons with MS with slowed CPS. The heterogeneous pattern of baseline variables that predicted adherence and compliance rates overall and in the respective experimental conditions warrant replication in larger MS samples.

Indexed as

Exercise TherapyMultiple SclerosisPatient ComplianceAdultFemaleHumansMaleMiddle AgedProcessing SpeedAdherenceComplianceExerciseMultiple sclerosisSafety

Identifiers

PMID40912162
PMCPMC12421912

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.