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Efficacy of an m-health physical activity and sleep intervention to improve sleep quality in middle-aged adults: the Refresh study randomized controlled trial
Rayward AT, Plotnikoff RC, Murawski B, Vandelanotte C, Brown WJ, Holliday EG, Duncan MJ
Annals of Behavioral Medicine 2020 Jul;54(7):470-483
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Poor sleep health is highly prevalent. Physical activity is known to improve sleep quality but not specifically targeted in sleep interventions. PURPOSE: To compare the efficacy of a combined physical activity and sleep intervention with a sleep-only intervention and a wait-list control, for improving sleep quality in middle-aged adults without a diagnosed sleep disorder. METHODS: Three-arm randomized controlled trial (physical activity and sleep health (PAS), sleep health only (SO), wait-list control (CON) groups; 3-month primary time-point, 6-month follow-up) of 275 (PAS = 110, SO = 110, CON = 55) inactive adults (40 to 65 years) reporting poor sleep quality. The main intervention component was a smartphone/tablet "app" to aid goal setting and self-monitoring physical activity and/or sleep hygiene behaviors (including stress management), and a pedometer for PAS group. Primary outcome was Pittsburgh Sleep Quality Index (PSQI) global score. Secondary outcomes included several self-reported physical activity measures and PSQI subcomponents. Group differences were examined stepwise, first between pooled intervention (PI=PAS+SO) and CON groups, then between PAS and SO groups. RESULTS: Compared with CON, PI groups significantly improved PSQI global and subcomponents scores at 3 and 6 months. There were no differences in sleep quality between PAS and SO groups. The PAS group reported significantly less daily sitting time at 3 months and was significantly more likely to report >= 2 days/week resistance training and meeting physical activity guidelines at 6 months than the SO group. CONCLUSIONS: PIs had statistically significantly improved sleep quality among middle-aged adults with poor sleep quality without a diagnosed sleep disorder. The adjunctive physical activity intervention did not additionally improve sleep quality. CLINICAL TRIAL INFORMATION: Australian New Zealand Clinical Trial Registry ACTRN12617000680369; Universal Trial number U1111-1194-2680; Human Research Ethics Committee blinded by request of journal H-2016-0267.

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