Clinical trial NCT02164617: Wheelchair-bound Senior Elastic Band (WSEB) Exercise Program for the Demented Seniors
Official title: Development and Evaluation of an Evidence-based Intervention Guideline of the Wheelchair-bound Senior Elastic Band (WSEB) Exercise Program for the Demented Seniors in Long-term Care Facilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Dementia
Wheelchair-bound seniors
Long-term care facilities
Elastic band exercise
Functional fitness
Daily life function
Depression
Problem behaviors
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2014-06-16
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* aged 65 and over
* diagnosed with dementia by a physician or screened by the Mini-Mental State Examination (MMSE) as dementia
* wheelchair-bound seniors
* living in the long-term care facility for at least three months

Exclusion Criteria:

* having severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses
* suffering from spinal cord injury with no rehabilitation potential

Primary outcomes:
measure: Change from baseline in functional fitness at 3, 6, 9, 12, 15 months
timeFrame: participants will be followed for 15 months
Secondary outcomes:
measure: Change from baseline in daily life function at 3, 6, 9, 12, 15 months
timeFrame: participants will be followed for 15 months
measure: Change from baseline in depression at 3, 6, 9, 12, 15 months
timeFrame: participants will be followed for 15 months
measure: Change from baseline in problem behaviors at 3, 6, 9, 12, 15 months
timeFrame: participants will be followed for 15 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
affiliation: Kaohsiung Medical University
name: Kuei-Min Chen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen MC, Chen KM, Chang CL, Chang YH, Cheng YY, Huang HT. Elastic Band Exercises Improved Activities of Daily Living and Functional Fitness of Wheelchair-bound Older Adults with Cognitive Impairment: A Cluster Randomized Controlled Trial. Am J Phys Med Rehabil. 2016 Nov;95(11):789-799. doi: 10.1097/PHM.0000000000000518.