- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02164617
Wheelchair-bound Senior Elastic Band (WSEB) Exercise Program for the Demented Seniors (WSEB)
June 13, 2015 updated by: Kuei-Min Chen, Ph.D., RN., Kaohsiung Medical University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kaohsiung, Taiwan, 80708
- Kaohsiung Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Wheelchair-bound Senior Elastic Band
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.
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Wheelchair-bound Senior Elastic Band exercise program (WSEB) three times per week, 40 minutes per practice
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|
No Intervention: control
routine care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
participants will be followed for 15 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in daily life function at 3, 6, 9, 12, 15 months
Time Frame: participants will be followed for 15 months
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measured by Barthel Index (BI)
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participants will be followed for 15 months
|
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Change from baseline in depression at 3, 6, 9, 12, 15 months
Time Frame: participants will be followed for 15 months
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measured by Cornell Scale for Depression in Dementia Chinese version (CSDD)
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participants will be followed for 15 months
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Change from baseline in problem behaviors at 3, 6, 9, 12, 15 months
Time Frame: participants will be followed for 15 months
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Clifton Assessment Procedures for the Elderly-Behavior Rating Scale Chinese version (CAPE-BRS)
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participants will be followed for 15 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kuei-Min Chen, Ph.D., Kaohsiung Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
June 10, 2014
First Submitted That Met QC Criteria
June 11, 2014
First Posted (Estimate)
June 16, 2014
Study Record Updates
Last Update Posted (Estimate)
June 16, 2015
Last Update Submitted That Met QC Criteria
June 13, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUHIRB-2012-01-02(II)
- NSC-102-2314-B-037-054-MY2 (Other Grant/Funding Number: National Science Council)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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