This study was a multicenter, randomized, open-label, cross-over trial, and was conducted at 7 nursing homes in Japan. Elder people over 60 years with LUTS, constipation, insomnia, or HC as clinically diagnosed were randomized. Patients were excluded if they cannot walk by themselves. Eligible patients were then randomized in 1:1 ratio to the ADH preceding group and the SS preceding group using envelope method. ADH used in this study was made of bamboo, 40 cm in length, 8.5 cm in width, 4.5 cm in height, and almost 290 g in weight. (Figure B) The ADHi was brought to each participant’s nursing homes. ADH and SS was performed twice a day, in the morning (after waking up) and evening (after taking a bath/shower or before going to bed) for 28 days. Holding something such as the wall, desk, or pillar, participants placed the arches of both feet on the ADH, and then made repeated steps for 2 min in a set as shown in Figure C-F. In accordance with the usual use of ADH, steps were made 30– 60 times/min, and participants could control the rate by themselves. If participants felt pain, they could reduce use to once a day. Achievement rates of ADH and SS were counted for evaluation of harmfulness of ADH.
ADH and SS were done twice a day for 28 days. Before and 28 days after starting ADH or SS, international prostate symptom score (IPSS), quality-of-life (QoL) score, overactive bladder symptom score (OABSS), Athene Insmnia Scale (AIS), a visual analogue scale on constipation (VAS-constipation), HC (VAS-HC), and defecation frequency were used for evaluation. After 28 days of initial treatment, ADH and SS were crossed each other, then ADH and SS were done for 28 days.
The obtained results were compared between the baseline and the results after ADH or SS using paired t-test statistically. And, the ADH and SS were also compared statistically using unpaired t-test.