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Clinical Trial Summary

The goals of this three-year research project were: 1) to develop and evaluate the feasibility of the Wheelchair-bound Senior Elastic Band (WSEB) for the demented, wheelchair-bound seniors in long-term care facilities, 2) to evaluate the long-term effects of the instructor-led WSEB on the functional fitness, daily life function, depression, and problem behaviors of this senior population, and 3) to test the feasibility, compliance, and effectiveness of the DVD-led WSEB on this senior population.


Clinical Trial Description

A three-year, longitudinal, triangulation research method was applied. First Year (Phase I): A preliminary WSEB, including hard copy descriptions and DVD demonstrations of each exercise, were sent to the 12 experts in the Delphi advisory panel for their critique and evaluation. First Year (Phase II): A quasi-experimental, one-group, pretest-posttest design was used to pilot-test the feasibility of the WSEB on a group of 15-20 demented, wheelchair-bound seniors in long-term care facilities. Second Year: A quasi-experimental, pre-post tests, non-equivalent control group design was used to test the long-term effects of the instructor-led WSEB on the functional fitness (cardiovascular-respiratory function, body flexibility, range of the joint's motion, and muscle strength and endurance), daily life function, depression, and problem behaviors of the demented, wheelchair-bound seniors in long-term care facilities. Eight long-term care facilities with 150 demented, wheelchair-bound seniors from southern Taiwan were recruited and randomly assigned based on the facilities to a WSEB experimental group or a waiting-list control group. Participants in the experimental group received the WSEB lead by the pre-trained and certified instructors, three times per week, 40 minutes per practice for 24 weeks; participants in the waiting-list control group remained regular activities in the facilities. One pre-test and two post-tests, 12 weeks apart, were conducted. Third Year: Using the same method as in the second year, participants from the second year were continued practicing the WSEB, but guided by a DVD, for another 36 weeks. The feasibility, compliance, and effectiveness of the DVD-led WSEB on the demented, wheelchair-bound seniors in long-term care facilities were tested, and another three post-tests, 12 weeks apart, were conducted on the same outcome measurements as in the second year. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT02164617
Study type Interventional
Source Kaohsiung Medical University
Contact
Status Completed
Phase N/A
Start date March 2014
Completion date June 2015

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