Dataset Information

Effects of a Remote Multimodal Intervention Involving Diet, Walking Program, and Breathing Exercise on Quality of Life Among Newly Diagnosed People with Multiple Sclerosis: A Quasi-Experimental Non-Inferiority Pilot Study.

ABSTRACT:

Background

Interventions involving diet, physical activity, and breathing exercises are shown to be beneficial in managing both fatigue and quality of life (QoL) related to MS; however, the impact of such interventions among people newly diagnosed with clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS) who decline disease-modifying therapies (DMTs) is unknown.

Methods

A 12-month prospective quasi-experimental non-inferiority trial recruited people newly diagnosed with CIS or RRMS who voluntarily declined DMTs (health behavior group; HB, n = 29) or followed standard of care (SOC, n = 15). Participants in the HB group were remotely coached on the study diet, moderate-intensity walking, and breathing exercises. All participants completed questionnaires validated to assess MS symptoms, including perceived mental and physical QoL (MSQOL54); fatigue (Fatigue Severity Scale, FSS; and Modified Fatigue Impact Scale, MFIS); mood (Hospital Anxiety and Depression Scale, HADS); and cognitive function (Perceived Deficits Questionnaire, PDQ).

Results

During the 12 months, the HB group experienced improvement in scores for mental QoL (MSQOL54 - Mental, 0.24, 95% CI 0.01, 0.47; p = 0.04), fatigue (Total MFIS, -7.26, 95% CI -13.3,-1.18; p = 0.02), and perceived cognitive function (Total PDQ, PDQ-Attention, PDQ-Promemory, and PDQ-Planning, p ≤ 0.03 for all). A between-group difference was observed only for PDQ-Planning (p = 0.048). Non-inferiority analysis revealed that the 12-month changes in means for the HB group were not worse than those for the SOC group with respect to fatigue (FSS, p = 0.02), mood (HDS-Anxiety, p = 0.02; HADS-Depression, p < 0.0001), physical QoL (MSQOL54 - Physical, p = 0.02), or cognitive dysfunction (Total PDQ, p = 0.01).

Conclusion

The multimodal lifestyle intervention for individuals newly diagnosed with CIS or RRMS, who voluntarily decline DMTs, did not yield patient-reported outcomes worse than those observed in the SOC group regarding perceived mental quality of life, mood, fatigue, and cognitive function.

Trial registration

clinicaltrials.gov identifier: NCT04009005.

SUBMITTER: Saxby SM

PROVIDER: S-EPMC10787513 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effects of a Remote Multimodal Intervention Involving Diet, Walking Program, and Breathing Exercise on Quality of Life Among Newly Diagnosed People with Multiple Sclerosis: A Quasi-Experimental Non-Inferiority Pilot Study.

Saxby Solange M SM Shemirani Farnoosh F Crippes Landon J LJ Ehlinger Mary A MA Brooks Lisa L Bisht Babita B Titcomb Tyler J TJ Rubenstein Linda M LM Eyck Patrick Ten PT Hoth Karin F KF Gill Christine C Kamholz John J Snetselaar Linda G LG Wahls Terry L TL

Degenerative neurological and neuromuscular disease 20240109

<h4>Background</h4>Interventions involving diet, physical activity, and breathing exercises are shown to be beneficial in managing both fatigue and quality of life (QoL) related to MS; however, the impact of such interventions among people newly diagnosed with clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS) who decline disease-modifying therapies (DMTs) is unknown.<h4>Methods</h4>A 12-month prospective quasi-experimental non-inferiority trial recruited people ...[more]

PMID: 38222092

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Project description:BackgroundIndividuals who are newly diagnosed with clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS) may choose not to undergo disease-modifying therapies (DMTs) due to concerns about expenses or potential adverse effects. Thus, many individuals will opt for alternative therapies, such as dietary modifications. Among these dietary approaches, the modified Paleolithic elimination diet has shown promise for improving MS-related symptoms; however, restriction of certain food groups can lead to inadequate intake of nutrients.MethodsThree-day self-reported 24-h dietary recalls using the Automated Self-Administered 24-h (ASA24) Dietary Assessment Tool were assessed during a 12-month quasi-experimental (i.e., non-randomized) trial among individuals who either voluntarily declined DMTs and received health behavior (HB) intervention, (n = 29) or included DMTs and opted for the standard of care (SOC; n = 15). Participants in the HB group received a multimodal intervention that included dietary modifications, a walking program, and breathing exercises. Usual intake of each micronutrient was estimated and then evaluated with the estimated average requirement (EAR)-cut point method.ResultsAt 12 months, >80% of both HB and SOC groups completed 3 days of the self-reported 24-h recalls, indicating the potential feasibility of ASA24. From baseline to 12 months, the HB group had a decreased mean ratio in total grains (0.64; 95% CI 0.43-0.93; p = 0.02) and added sugars (0.52; 95% CI 0.35-0.75; p ≤ 0.001), and an increased mean ratio intake of cured meats (1.74; 95% CI 1.05-2.90; p = 0.04); whereas, the SOC group had a decreased mean ratio intake for beef, veal, pork, lamb, and game meat (0.60; 95% CI 0.40-0.90; p = 0.01). At baseline, both groups had high proportions with inadequate intake of vitamin E and calcium. The SOC group also had a high proportion with inadequate intake of vitamin D. By 12-months, the HB group exhibited severe proportions of nutrient inadequacies (>20% of the group) for vitamin D (43.5%), vitamin E (29.1%), calcium (69.9%), and copper (27.8%). The SOC group, following their own diet, had inadequacies for all the same micronutrients, except for copper, as the HB group. The SOC group also had additional inadequacies: vitamin A (21.3%), thiamin (26.3%), riboflavin (24.2%), folate (24.8%), vitamin B12 (27.8%), and zinc (28.2%).ConclusionCompared to the usual diet, adhering to the modified Paleolithic elimination diet, as a component of a 12-month multimodal intervention, may lead to reduced consumption of specific food groups, such as added sugars, as well as decreased risk of severe proportions of inadequacy for certain nutrients. The utilization of the ASA24 for acquiring dietary recalls from participants with MS may be feasible for future studies.Clinical trial registrationclinicaltrials.gov identifier NCT04009005.

Project description:BACKGROUND:There are currently no data on the prevalence of sleep-disordered breathing (SDB) in patients with newly-diagnosed lung cancer. This might be of interest given that SDB is associated with increased cancer incidence and mortality. Furthermore, intermittent hypoxia has been linked with tumor growth and progression. The aim of the current study was to investigate the prevalence of SDB in patients with newly-diagnosed lung cancer. METHODS:Patients with newly-diagnosed lung cancer from three centers in Germany were screened for SDB using a two-channel screening system (ApneaLink™). SDB was defined as an apnea-hypopnea index of > 5/h, and was classified as mild if the AHI was 5-15/h whereas an AHI ≥15/h was classified as severe SDB. The presence of SDB-related symptoms was assessed using the Epworth Sleepiness Scale (ESS) and the Pittsburgh Sleep Quality Index (PSQI). RESULTS:A total of 100 patients were included. The overall prevalence of SDB was 49%; 32 patients (32%) had mild SDB with a median AHI of 7.7/h (quartile [Q1 5.4/h, Q3 10.4/h]) and a median oxygen desaturation index of 8.5 [Q1 4.2/h; Q3 13.4/h] and seventeen patients (17%) had moderate to severe SDB with a median AHI of 25.2 [Q1 18/h, Q3 45.5/h] and a median oxygen desaturation index of 20.6/h [Q1 9.6/h, Q3 36.6/h]. Patients with moderate to severe SDB had mild daytime sleepiness (ESS score 8.24 ± 3.96 vs. 5.74 ± 3.53 in those without SDB vs. 6.22 ± 2.72 in those with mild SDB; p = 0.0343). The PSQI did not differ significantly between the three groups (p = 0.1137). CONCLUSIONS:This study showed a high prevalence of SDB in patients with newly-diagnosed lung cancer. In these patients SDB was associated with intermittent hypoxia and increased daytime sleepiness. Additional research is needed to determine whether SDB influences prognosis and morbidity in patients with lung cancer. TRIAL REGISTRATION:NCT02270853 (ClinicalTrials.gov), date of registration: 14th October 2014.

Dataset Information

Effects of a Remote Multimodal Intervention Involving Diet, Walking Program, and Breathing Exercise on Quality of Life Among Newly Diagnosed People with Multiple Sclerosis: A Quasi-Experimental Non-Inferiority Pilot Study.

Background

Methods

Results

Conclusion

Trial registration

Publications

Effects of a Remote Multimodal Intervention Involving Diet, Walking Program, and Breathing Exercise on Quality of Life Among Newly Diagnosed People with Multiple Sclerosis: A Quasi-Experimental Non-Inferiority Pilot Study.

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