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Clinical Trials/NCT02164617
NCT02164617
Completed
Not Applicable

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

Kaohsiung Medical University1 site in 1 country150 target enrollmentMarch 2014
ConditionsDementia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
Kaohsiung Medical University
Enrollment
150
Locations
1
Primary Endpoint
Change from baseline in functional fitness at 3, 6, 9, 12, 15 months
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
June 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kuei-Min Chen, Ph.D., RN.

Professor

Kaohsiung Medical University

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

Outcomes

Primary Outcomes

Change from baseline in functional fitness at 3, 6, 9, 12, 15 months

Time Frame: participants will be followed for 15 months

1. Functional Fitness 1.1 Cardiovascular-Respiratory Function 1.1.1 Blood Pressure Digital Sphygmomanometer (OMRON - HEM707) 1.1.2 Lung Capacity TruZoneTM Peak Flow Meter 1.2 Body Flexibility 1.2.1 Upper Body Flexibility Back Scratch Test 1.2.2 Lower Body Flexibility Chair Sit-and-Reach Test 1.3 Range of the Joint's Motion 1.3.1 Flexion of the Shoulder Joint Goniometry 1.3.2 Abduction of the Shoulder Joint Goniometry 1.4 Muscle Strength and Endurance 1.4.1 Hand-Grip Strength Digital Handgrip Dynamometer (TKK - 5101) 1.4.2 Arm Muscle Endurance Arm Curl Test

Secondary Outcomes

  • Change from baseline in daily life function at 3, 6, 9, 12, 15 months(participants will be followed for 15 months)
  • Change from baseline in depression at 3, 6, 9, 12, 15 months(participants will be followed for 15 months)
  • Change from baseline in problem behaviors at 3, 6, 9, 12, 15 months(participants will be followed for 15 months)

Study Sites (1)

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