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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

The effects of an activity-based lifestyle intervention on moderate sleep complaints among older adults: study protocol for a randomized controlled trial

Trials > Ausgabe 1/2018
Doris, S.F. Yu, Shamay S.M. Ng, Diana T.F. Lee, Kai Chow Choi, Parco M.F. Siu, Lisa P.L. Low, Jean Woo
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Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2465-2) contains supplementary material, which is available to authorized users.



Moderate sleep complaints are major gerontological issue affecting as many as 80% of older adults. More intriguing findings have indicated that moderate sleep complaints were associated with cognitive decline, functional deterioration, clinical depression, and even morbidity and mortality among older adults. The aim of this study is to evaluate the effects of an activity-based lifestyle intervention on moderate sleep complaint among community-dwelling older adults.


This sequential quantitative–qualitative mixed method study will randomly allocate 224 individuals to receive either the 16-week group-based moderate-intensity stepping exercise or 16-week health education. The exercise group receives three 60-min stepping exercises per week, whereas the education group receives weekly educative talks on health topics other than sleep. The primary outcomes are sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) and sleep pattern as measured by the actiwatch. Physical fitness and mood status are measured as mediating variables by using the Rockport walking test and Profile of Mood States. The qualitative part will invite 30 individuals from the exercise group who have different sleep-related treatment responses to participate in individual interviews to explore their overall perception of using stepping exercise as a lifestyle intervention to improve sleep. Mixed effects model with intention-to-treat analysis will be used for quantitative data. Inductive thematic analysis with a prior coding framework will be used for the qualitative data.


By investigating the effects and the mediating mechanism of a moderate-intensity exercise program on moderate sleep complaints among older adults, this study will generate evidence of high scientific value and important public health implication. Understanding the sleep-promoting effects and acceptability of exercise informs how to apply lifestyle promotion as a public health practice to improve late-life moderate sleep complaints and forestall its progression to level of clinical severity.

Trial registration

Clinical Trial Registry Team, Center for Clinical Research and Biostatistics CUHK, CCRB00491. Registered on 1 December 2015.
Additional file 1: SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*. (DOC 122 kb)
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