Comprehensive geriatric intervention program with and without weekly class-style exercise: research protocol of a cluster randomized controlled trial in Kyoto-Kameoka Study
Received 12 September 2017
Accepted for publication 18 March 2018
Published 24 May 2018 Volume 2018:13 Pages 1019—1033
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 3
Editor who approved publication: Dr Richard Walker
Yuya Watanabe,1–4,* Yosuke Yamada,2,4,* Keiichi Yokoyama,2,5,6,* Tsukasa Yoshida,2,4,7 Yasuko Yoshinaka,5,6 Mie Yoshimoto,8 Yoko Tanaka,9 Aya Itoi,10 Emi Yamagata,11 Naoyuki Ebine,1 Kazuko Ishikawa-Takata,12 Misaka Kimura2,3
1Faculty of Health and Sports Science, Doshisha University, Kyotanabe, Japan; 2Laboratory of Applied Health Sciences, Kyoto Prefectural University of Medicine, Kyoto, Japan; 3Department of Health and Sports Sciences, Kyoto Gakuen University, Kameoka, Japan; 4Section of Healthy Longevity Research, National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition, Tokyo, Japan; 5Specified Non-profit Corporation Genki-up AGE Project, Kameoka, Japan; 6Department of Business Administration, Kyoto Gakuen University, Kyoto, Japan; 7Senior Citizen’s Welfare Section, Kameoka City Government, Kameoka, Japan; 8Corporation of Japan Dental Hygienists’ Association, Kyoto, Japan; 9Kyoto Dietetic Association, Kyoto, Japan; 10Department of Health, Sports and Nutrition, Faculty of Health and Welfare, Kobe Women’s University, Kobe, Japan; 11Faculty of Nursing, Doshisha Women’s College of Liberal Arts, Kyotanabe, Japan; 12Department of Nutrition and Metabolism, National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition, Tokyo, Japan
*These authors contributed equally to this work
Objective: The number of long-term care (LTC) users and the associated expenditures in Japan are increasing dramatically. The national government recommends LTC prevention through activation of communities. However, there is no clear evidence of the effect of population-based comprehensive geriatric intervention program (CGIP) for restraints of LTC users and the associated expenditures in the future. The aims of the current paper are to describe the study protocol and progress of a cluster randomized controlled trial (RCT) with a CGIP in Kameoka City.
Methods: The cluster RCT involved random allocation of regions as intervention (n=4,859) and nonintervention (n=7,195). Participants were elderly persons aged ≥65 years without LTC certification who had responded to a mailing survey. The residents living in intervention regions were invited to a physical check-up, and 1,463 people participated (30.3%). These individuals were invited to the CGIP, and 526 accepted. The CGIP comprised instructions on: 1) low-load resistance training using bodyweight, ankle weights, and elastic bands; 2) increasing daily physical activity; 3) oral motor exercise and care; and 4) a well-balanced diet based on a program from Ministry of Health, Labour and Welfare. We allocated the intervention regions randomly into home-based self-care program alone (HB group, 5 regions, n=275) and home-based program+weekly class-style session (CS group, 5 regions, n=251). We evaluated the effects of the CGIP at 12 weeks and at 12 or 15 months on physical function, and are conducting follow-up data collection for an indefinite period regarding LTC certification, medical costs, and mortality.
Results and discussion: The study was launched with good response rates in each phase. Participants of both groups significantly increased their step counts by ~1,000 per day from the baseline during the CGIP. This RCT will provide valuable information and evidence about effectiveness of a community-based CGIP.
Keywords: frailty, sarcopenia, long-term care, ActiveGuide, low-load resistance training, oral care, nutritional intervention, Shokuiku, physical function, physical activity monitor
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