Changes in cardiorespiratory function and fatigue following 12 weeks of exercise training in women with systemic lupus erythematosus: a pilot study

Feng, Li Rebekah; Chapman, Marquis; Gupta, Sarthak; Ahmad, Anam; Munday, Adam D.; Mazhar, Mir Ali; Li, Xiaobai; Lu, Shajia; Tsai, Wanxia Li; Gadina, Massimo; Davis, Michael J.; Chu, Jun; Manna, Zerai; Nakabo, Shuichiro; Kaplan, Mariana J.; Saligan, Leorey N.; Keyser, Randall E.; Chan, Leighton; Chin, Lisa M.K.

doi:10.1136/lupus-2022-000778

Cited by 2 publications

(1 citation statement)

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“…Therefore, no sample size was calculated for this co-primary outcome. However, since initiation of this study a pre-post study of physical activity in SLE patients reported an improvement from 4.6 (+/-1.2) to 3.1 (+/-1.4) 34 , using these estimates in a post-hoc power calculation would give us a statistical power of 95.3% with 40 completers and power of 80.5% with 24 completers.…”

Section: Sample Size Calculationmentioning

confidence: 97%

Type I interferon induced differences in exercise adaptations of aerobic capacity and fatigue in systemic lupus erythematosus – A randomised controlled single-centre trial v1.0

Adamsen,

Jønck,

Christensen

et al. 2024

Preprint

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Impaired exercise capacity and persistent fatigue are common manifestations in patients with systemic lupus erythematosus (SLE) even during disease remission. Knowledge on pathophysiologic mechanisms causing these disease manifestations is limited. SLE is characterised by various immune system dysregulations including an overexpression of type 1 interferons (IFN-I). This study aims to examine whether higher IFN-I activity negatively correlates with improvement in aerobic capacity and fatigue following a 12-week exercise intervention. Sixty adult patients with SLE will be randomised 1:1 stratified for sex to exercise or control. The exercise group will undergo bouts of high intensity interval training (HIIT), 45 minutes 3 times weekly for 12 weeks. The control group is informed to maintain current physical activity during study participation. Clinical, patient-reported, laboratory and imaging data will be collected before, during, and after the study period. The primary outcome is aerobic capacity measured by maximal oxygen uptake (VO2max). The co-primary outcome is fatigue measured by the fatigue severity scale (FSS) questionnaire. Transcriptomic analysis use Nanostring technology to obtain IFN gene signature (IFNGS). The predictive value of the IFNGS on the outcomes will be assessed by regression models including pre-specified covariates of interest. Analysis will be done per protocol (PP) and as intention to treat (ITT).The study has been approved by the ethics committee of the Capital Region of Denmark (H-21039032) and clinicaltrials.gov (NCT05478018). Results from this study will be disseminated through peer-reviewed publications, conference presentations and clinical communications. Strengths and limitations:The first randomised controlled exercise trial of SLE patients investigating the impact of interferon signature on patient-reported and physiological exercise outcomes. A novel approach to gain insight into underlying mechanisms of fatigue and reduced exercise capacity in SLE.Patients enrolling in an exercise study might be healthier than the general SLE population, which may limit the external validity of our results. Due to the nature of exercise therapy blinding of patients to the intervention is not possible, which may introduce performance bias (e.g., regarding patient-reported outcomes)The exercise protocol with short bursts of highly intensive aerobic exercise might impact aerobic capacity more than it influences fatigue and muscle strength.

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Section: Sample Size Calculationmentioning

confidence: 97%