{"doi":"10.1016/j.cct.2024.107446","title":"Internet-delivered lifestyle physical activity intervention for cognitive processing speed in multiple sclerosis","abstract":"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.","journal":"Contemporary Clinical Trials","year":2024,"id":478348,"datarank":0.1732868802858553,"base_score":1.0986122886681096,"endowment":1.0986122886681096,"self_citation_contribution":0.16479184330021646,"citation_network_contribution":0.008495036985638834,"self_endowment_contribution":0.16479184330021646,"citer_contribution":0.008495036985638834,"corpus_percentile":null,"corpus_rank":null,"citation_count":2,"citer_count":1,"citers_with_citation_signal":1,"citers_with_endowment":1,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9547,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT04518657"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":307884,"name":"Brian M. Sandroff","orcid":"0000-0002-2013-7632","position":1,"is_corresponding":false},{"id":397563,"name":"Ralph H. B. Benedict","orcid":"0000-0002-2080-3631","position":2,"is_corresponding":false},{"id":1317170,"name":"Roberto G. Aldunate","orcid":null,"position":3,"is_corresponding":false},{"id":270886,"name":"Gary Cutter","orcid":"0000-0002-8455-980X","position":4,"is_corresponding":false},{"id":1317171,"name":"Emily Barron","orcid":null,"position":5,"is_corresponding":false},{"id":441740,"name":"Robert W. Motl","orcid":"0000-0003-0112-2803","position":0,"is_corresponding":true}],"reference_count":56,"raw_metadata":null,"created_at":"2026-07-19T02:06:42.155024Z","pmid":"38242351","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}