DementiaWSEBNCT02164617
Wheelchair-bound Senior Elastic Band (WSEB) Exercise Program for the Demented Seniors
A study testing Wheelchair-bound Senior Elastic Band exercise program (WSEB) in people with Dementia, run by Kaohsiung Medical University at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Wheelchair-bound Senior Elastic Band exercise program (WSEB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- having severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses
- suffering from spinal cord injury with no rehabilitation potential
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Wheelchair-bound Senior Elastic Band exercise program (WSEB)
- Keywords
- Dementia, Wheelchair-bound seniors, Long-term care facilities, Elastic band exercise, Functional fitness, Daily life function, Depression, Problem behaviors
- Medical subject headings
- Dementia, Depression, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheelchair-bound Senior Elastic Band exercise program (WSEB)Other
Wheelchair-bound Senior Elastic Band exercise program (WSEB) three times per week, 40 minutes per practice
| Study group | Role | What they receive |
|---|---|---|
| Wheelchair-bound Senior Elastic Band | Experimental | 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. Receives: Other: Wheelchair-bound Senior Elastic Band exercise program (WSEB) |
| control | No intervention | routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in functional fitness at 3, 6, 9, 12, 15 months
- 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
Measured: participants will be followed for 15 months
Secondary outcomes (3)
Change from baseline in daily life function at 3, 6, 9, 12, 15 months
measured by Barthel Index (BI)
Measured: participants will be followed for 15 months
Change from baseline in depression at 3, 6, 9, 12, 15 months
measured by Cornell Scale for Depression in Dementia Chinese version (CSDD)
Measured: participants will be followed for 15 months
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)
Measured: participants will be followed for 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Kuei-Min Chen, Ph.D., RN., Kaohsiung Medical University
- Investigators
- Kuei-Min Chen, Ph.D., Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164617
- Sponsor's protocol ID
- KMUHIRB-2012-01-02(II)
- Other IDs
- NSC-102-2314-B-037-054-MY2
- Acronym
- WSEB
- Status last verified
- Jun 2015
- First submitted
- 10 Jun 2014
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27149585
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02164617
- Acronym / sponsor ID
- WSEB / KMUHIRB-2012-01-02(II)
- Conditions
- Dementia
- Keywords
- Dementia, Wheelchair-bound seniors, Long-term care facilities, Elastic band exercise, Functional fitness, Daily life function, Depression, Problem behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wheelchair-bound Senior Elastic Band | Experimental | Other: Wheelchair-bound Senior Elastic Band exercise program (WSEB)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. |
| control | No intervention | –routine care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- having severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses
- suffering from spinal cord injury with no rehabilitation potential
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wheelchair-bound Senior Elastic Band exercise program (WSEB)Wheelchair-bound Senior Elastic Band exercise program (WSEB) three times per week, 40 minutes per practice | Other | Wheelchair-bound Senior Elastic Band |
Primary outcome
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
3 secondary outcomes
Change from baseline in daily life function at 3, 6, 9, 12, 15 months
Time frame: participants will be followed for 15 months
Change from baseline in depression at 3, 6, 9, 12, 15 months
Time frame: participants will be followed for 15 months
Change from baseline in problem behaviors at 3, 6, 9, 12, 15 months
Time frame: participants will be followed for 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
- Derived from this study: PubMed 27149585Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuei-Min Chen, Ph.D. principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheelchair-bound Senior Elastic Band exercise program (WSEB) in people with Dementia, run by Kaohsiung Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in functional fitness at 3, 6, 9, 12, 15 months (time frame: participants will be followed for 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02164617, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.