Tokyo, Jan. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060359) titled 'Community based voluntary frailty prevention exercise in older adults living in a resource limited rural area: a 6 month non-randomized longitudinal pilot study (The Ainan Study)' on Jan. 15.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Ehime Prefectural Minamiuwa Hospital

Condition: Condition - Frailty in community dwelling older adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate the effects of a community based voluntary frailty prevention exercise intervention on muscle strength, physical function, and body composition over 6 months in community dwelling older adults living in a resource limited rural area. The primary objective is to assess the change in muscle strength as measured by grip strength from baseline to 6 months. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The intervention group (n=8) participated in a 6-month community-based voluntary multicomponent frailty prevention exercise program jointly developed by physical and occupational therapists. The program was primarily self-managed and incorporated into participants' daily routines at home and in the community. The program consisted of seven exercise components: (1) stretching; (2) low-intensity resistance training using 500g water bottles; (3) dual-task exercises; (4) sit-to-stand movements; (5) balance training; (6) stair climbing; and (7) hill walking. Interventions/Control_2 - The control group (non-intervention group; n=6) continued their usual daily activities during the study period and received no structured exercise program as part of the study.

Eligibility: Age-lower limit - 65 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Eligible participants were community-dwelling older adults who met all of the following criteria:

(1) Aged 65 years or older and residing in Ainan Town, Minamiuwa District, Ehime Prefecture, Japan (both sexes eligible). (2) Able to understand the study procedures and provide written informed consent personally. (3) Not prohibited from exercising by a physician and judged medically safe to participate in exercise. (4) No physician-diagnosed dementia.

Eligibility was confirmed through an interview and medical history taking. Key exclusion criteria - Participants were excluded if they met any of the following criteria:

(1) Medical contraindication to exercise or physician-imposed restrictions on exercise. (2) Severe cardiovascular, respiratory, or musculoskeletal disease (or other serious conditions) that would preclude safe participation and/or completion of assessments. (3) Difficulty understanding the study procedures or providing informed consent (including inability to provide written consent due to dementia or related conditions). (4) Judged unlikely to be able to complete the primary outcome assessments. (5) Any other condition for which the principal investigator determined that continued participation would be inappropriate due to safety concerns or feasibility of study conduct. Target Size - 14

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 07 Month 04 Day Date of IRB - 2024 Year 07 Month 04 Day Anticipated trial start date - 2024 Year 09 Month 22 Day Last follow-up date - 2025 Year 03 Month 16 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069040

Disclaimer: Curated by HT Syndication.