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Wheelchair-bound Senior Elastic Band (WSEB) Exercise Program for the Demented Seniors (WSEB)

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Wheelchair-bound Senior Elastic Band exercise program (WSEB)
Sponsored by
Kaohsiung Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dementia focused on measuring Dementia, Wheelchair-bound seniors, Long-term care facilities, Elastic band exercise, Functional fitness, Daily life function, Depression, Problem behaviors

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaohsiung Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Wheelchair-bound Senior Elastic Band

control

Arm Description

Wheelchair-bound Senior Elastic Band (WSEB) exercise program has three phases: 1) warm-up: 6 movements to loosen up the body and elevate the energy for a safe transition to the next phase, 2) aerobic motions: 6 low-to-medium speed exercises to enhance the cardiovascular-respiratory workout, and 3) static stretching: 6 low-speed, gentle stretching exercises to build up muscle power/endurance and increase range of motion and flexibility. It is conducted three times per week, 40 minutes per practice.

routine care

Outcomes

Primary Outcome Measures

Change from baseline in functional fitness at 3, 6, 9, 12, 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 Outcome Measures

Change from baseline in daily life function at 3, 6, 9, 12, 15 months
measured by Barthel Index (BI)
Change from baseline in depression at 3, 6, 9, 12, 15 months
measured by Cornell Scale for Depression in Dementia Chinese version (CSDD)
Change from baseline in problem behaviors at 3, 6, 9, 12, 15 months
Clifton Assessment Procedures for the Elderly-Behavior Rating Scale Chinese version (CAPE-BRS)

Full Information

First Posted
June 10, 2014
Last Updated
June 13, 2015
Sponsor
Kaohsiung Medical University
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT02164617
Brief Title
Wheelchair-bound Senior Elastic Band (WSEB) Exercise Program for the Demented Seniors
Acronym
WSEB
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

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Medical University
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Dementia, Wheelchair-bound seniors, Long-term care facilities, Elastic band exercise, Functional fitness, Daily life function, Depression, Problem behaviors

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wheelchair-bound Senior Elastic Band
Arm Type
Experimental
Arm Description
Wheelchair-bound Senior Elastic Band (WSEB) exercise program has three phases: 1) warm-up: 6 movements to loosen up the body and elevate the energy for a safe transition to the next phase, 2) aerobic motions: 6 low-to-medium speed exercises to enhance the cardiovascular-respiratory workout, and 3) static stretching: 6 low-speed, gentle stretching exercises to build up muscle power/endurance and increase range of motion and flexibility. It is conducted three times per week, 40 minutes per practice.
Arm Title
control
Arm Type
No Intervention
Arm Description
routine care
Intervention Type
Other
Intervention Name(s)
Wheelchair-bound Senior Elastic Band exercise program (WSEB)
Intervention Description
Wheelchair-bound Senior Elastic Band exercise program (WSEB) three times per week, 40 minutes per practice
Primary Outcome Measure Information:
Title
Change from baseline in functional fitness at 3, 6, 9, 12, 15 months
Description
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
Time Frame
participants will be followed for 15 months
Secondary Outcome Measure Information:
Title
Change from baseline in daily life function at 3, 6, 9, 12, 15 months
Description
measured by Barthel Index (BI)
Time Frame
participants will be followed for 15 months
Title
Change from baseline in depression at 3, 6, 9, 12, 15 months
Description
measured by Cornell Scale for Depression in Dementia Chinese version (CSDD)
Time Frame
participants will be followed for 15 months
Title
Change from baseline in problem behaviors at 3, 6, 9, 12, 15 months
Description
Clifton Assessment Procedures for the Elderly-Behavior Rating Scale Chinese version (CAPE-BRS)
Time Frame
participants will be followed for 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuei-Min Chen, Ph.D.
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University
City
Kaohsiung
ZIP/Postal Code
80708
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27149585
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.
Results Reference
derived

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Wheelchair-bound Senior Elastic Band (WSEB) Exercise Program for the Demented Seniors

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