PMID- 38242351
OWN - NLM
STAT- MEDLINE
DCOM- 20240223
LR  - 20240306
IS  - 1559-2030 (Electronic)
IS  - 1551-7144 (Linking)
VI  - 138
DP  - 2024 Mar
TI  - Internet-delivered lifestyle physical activity intervention for cognitive 
      processing speed in multiple sclerosis.
PG  - 107446
LID - S1551-7144(24)00020-X [pii]
LID - 10.1016/j.cct.2024.107446 [doi]
AB  - BACKGROUND: We propose a randomized controlled trial(RCT) of a Social Cognitive 
      Theory-based(SCT), Internet-delivered behavioral intervention targeting lifestyle 
      physical activity(LPA) for yielding improvements in cognitive processing 
      speed(CPS), learning and memory(L/M), symptoms, and quality of life(QOL) among 
      persons with mild multiple sclerosis(MS)-related ambulatory impairment who have 
      impaired CPS. METHODS/DESIGN: The study involves a Phase-II, parallel group, RCT 
      design. Participants with MS(N = 300) will be randomly assigned on an equal 
      basis(1:1) into behavioral intervention(n = 150) or attention and social contact 
      control(n = 150) conditions. The conditions will be administered over 6-months by 
      trained behavior coaches who will be uninvolved in screening, recruitment, random 
      assignment, and outcome assessment. We will collect outcome data remotely every 
      6-months over the 12-month period(baseline, immediate follow-up, and 6-month 
      follow-up) using a treatment blinded assessor. The primary outcome is the raw, 
      oral Symbol Digit Modalities Test as a neuropsychological measure of CPS. The 
      secondary outcomes include the California Verbal Learning Test-II as an objective 
      measure of L/M, and patient-reported outcomes of fatigue, depressive symptoms, 
      anxiety, pain, and QOL. The tertiary outcome is accelerometry as an objective, 
      device-based measure of steps/day for generating a minimal clinically important 
      difference(MCID) value that guides the prescription of LPA for improving CPS in 
      clinical practice. The primary data analyses will involve intent-to-treat 
      principles, and mixed-effects models and logistic regression. DISCUSSION: If 
      successful, the proposed study will provide Class I evidence for the efficacy of 
      a theory-based, Internet-delivered behavioral intervention focusing on LPA for 
      improving CPS and mitigating its negative impact on other outcomes in persons 
      with MS. CLINICALTRIALS: gov: NCT04518657.
CI  - Copyright (c) 2024 The Author(s). Published by Elsevier Inc. All rights reserved.
FAU - Motl, Robert W
AU  - Motl RW
AD  - Department of Kinesiology and Nutrition, University of Illinois Chicago, 1919 W. 
      Taylor St, Chicago, IL 60612, USA.. Electronic address: robmotl@uic.edu.
FAU - Sandroff, Brian M
AU  - Sandroff BM
AD  - Center for Neuropsychology and Neuroscience Research, Kessler Foundation, 1199 
      Pleasant Valley Way, West Orange, NJ 07052, USA.
FAU - Benedict, Ralph H B
AU  - Benedict RHB
AD  - Jacobs School of Medicine, University at Buffalo, 1001 Main Street, Buffalo, NY 
      14203, USA.
FAU - Aldunate, Roberto
AU  - Aldunate R
AD  - Center for Innovation and Applied Research, 1807 Savanna Dr., Champaign, IL 
      61820, USA.
FAU - Cutter, Gary
AU  - Cutter G
AD  - Department of Biostatistics, University of Alabama Birmingham, 1665 University 
      Blvd, Birmingham, AL 35233, USA.
FAU - Barron, Emily
AU  - Barron E
AD  - Department of Kinesiology and Nutrition, University of Illinois Chicago, 1919 W. 
      Taylor St, Chicago, IL 60612, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT04518657
PT  - Journal Article
DEP - 20240117
PL  - United States
TA  - Contemp Clin Trials
JT  - Contemporary clinical trials
JID - 101242342
SB  - IM
MH  - Humans
MH  - Exercise
MH  - Internet
MH  - Life Style
MH  - *Multiple Sclerosis/complications/therapy/psychology
MH  - Processing Speed
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - Clinical Trials, Phase II as Topic
OTO - NOTNLM
OT  - Behavior
OT  - Cognition
OT  - Multiple sclerosis
OT  - Physical activity
OT  - Theory
COIS- Declaration of competing interest None.
EDAT- 2024/01/20 05:42
MHDA- 2024/02/23 06:43
CRDT- 2024/01/19 19:17
PHST- 2023/06/28 00:00 [received]
PHST- 2023/12/18 00:00 [revised]
PHST- 2024/01/15 00:00 [accepted]
PHST- 2024/02/23 06:43 [medline]
PHST- 2024/01/20 05:42 [pubmed]
PHST- 2024/01/19 19:17 [entrez]
AID - S1551-7144(24)00020-X [pii]
AID - 10.1016/j.cct.2024.107446 [doi]
PST - ppublish
SO  - Contemp Clin Trials. 2024 Mar;138:107446. doi: 10.1016/j.cct.2024.107446. Epub 
      2024 Jan 17.