Institutional Older AdultsSEBNCT02165150
Senior Elastic Band (SEB) on Institutional Elders
A study testing Wheelchair-bound Senior Elastic Band exercise program in people with Institutional Older Adults, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
The goals of this research project are: 1) to develop and evaluate the safety and feasibility of the Senior Elastic Band (SEB) exercise program for elderly residents in long term care facilities, 2) to evaluate the long-term effects of the SEB on physical functional fitness and sleep quality of elderly residents in… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Institutional Older Adults
- What is being tested?
- Wheelchair-bound Senior Elastic Band exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2010to Jul 2013
- 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
- elderly residents aged 65 and over
- Mandarin or Taiwanese speakers
- have been living in the facility for at least 3 months
- able to stand alone without assistive devices
- cognitively alert and able to verbally state their name, address, and answer questions.
Who cannot join
- participants with severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development, Application , and Evaluation of the Senior Elastic Band (SEB) Exercise Program for Elderly Residents in Long-term Care Facilities
The goals of this research project are: 1) to develop and evaluate the safety and feasibility of the Senior Elastic Band (SEB) exercise program for elderly residents in long term care facilities, 2) to evaluate the long-term effects of the SEB on physical functional fitness and sleep quality of elderly residents in long term care facilities, and 3) to investigate the compliance of elderly residents with long-term SEB exercises.
Read the detailed description
A three-year, longitudinal, triangulation research method will be used. The study purpose of the first year is to develop a safe and appropriate SEB program for the elderly residents in long term care facilities using Delphi survey with a panel of 12 experts and pilot-testing on a group of 15-20 elderly residents in long term care facilities. In the second year of the study, a quasi-experimental, non-equivalent control group design will be used to evaluate the effects of the SEB exercise program on the physical functional fitness (cardiovascular-respiratory function, body flexibility, muscle power/muscle endurance, and balance) and sleep quality of elderly residents in long term care facilities. Through the convenience sampling strategy, a total of four long term care facilities with approximately 120 elders in Kaohsiung will be recruited and randomly assigned based on the resided facilities to a SEB experimental group or a waiting-list control group. The subjects in the experimental group will receive the SEB interventions lead by the certified instructors, three times per week, 40 minutes per practice for six months; the subjects in the waiting-list control group will remain regular daily activities in the facilities. All subjects will receive one pre-test and two post-tests three months apart during the study. In the third year, the elderly participants will continue practicing the SEB guided by a VCD for another nine months, and the compliance of the participants toward regular SEB exercise and its long-term effects on the physical functional fitness and sleep quality outcomes will be tested with additional three post-tests, three months apart.
- Conditions
- Institutional Older Adults
- Being tested
- Wheelchair-bound Senior Elastic Band exercise program
- Keywords
- Elastic Band, Institutional Elders, Functional Fitness, Sleep Quality, Depression
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression
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 programOther
three times per week, 40 minutes per practice
| Study group | Role | What they receive |
|---|---|---|
| Wheelchair-bound Senior Elastic Band | Experimental | WSEB interventions three times per week, 40 minutes per practice Receives: Other: Wheelchair-bound Senior Elastic Band exercise program |
| 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 physical functional fitness at 3, 6, 9, 12, 15 months
including cardiovascular-respiratory function, body flexibility, muscle power/muscle endurance, and balance
Measured: participants will be followed for 15 months
Secondary outcomes (2)
Change from baseline in sleep quality at 3, 6, 9, 12, 15 months
measured by PSQI
Measured: participants will be followed for 15 months
Change from baseline in depression at 3, 6, 9, 12, 15 months
measured by Taiwanese Depression Questionnaire (TDQ)
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 posted17 Jun 2014 (estimated)
- Study startAug 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Institutional Older AdultsStudies 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
- None (open label)
- Enrolment
- 127 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
- NCT02165150
- Sponsor's protocol ID
- FYH-IRB-098-12-02
- Other IDs
- NSC99-2628-B-037-066-MY3
- Acronym
- SEB
- Status last verified
- Jun 2014
- First submitted
- 11 Jun 2014
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Application , and Evaluation of the Senior Elastic Band (SEB) Exercise Program for Elderly Residents in Long-term Care Facilities
- ClinicalTrials.gov ID
- NCT02165150
- Acronym / sponsor ID
- SEB / FYH-IRB-098-12-02
- Conditions
- Institutional Older Adults
- Keywords
- Elastic Band, Institutional Elders, Functional Fitness, Sleep Quality, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 17 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 research project are: 1) to develop and evaluate the safety and feasibility of the Senior Elastic Band (SEB) exercise program for elderly residents in long term care facilities, 2) to evaluate the long-term effects of the SEB on physical functional fitness and sleep quality of elderly residents in long term care facilities, and 3) to investigate the compliance of elderly residents with long-term SEB exercises.
Detailed description
A three-year, longitudinal, triangulation research method will be used. The study purpose of the first year is to develop a safe and appropriate SEB program for the elderly residents in long term care facilities using Delphi survey with a panel of 12 experts and pilot-testing on a group of 15-20 elderly residents in long term care facilities. In the second year of the study, a quasi-experimental, non-equivalent control group design will be used to evaluate the effects of the SEB exercise program on the physical functional fitness (cardiovascular-respiratory function, body flexibility, muscle power/muscle endurance, and balance) and sleep quality of elderly residents in long term care facilities. Through the convenience sampling strategy, a total of four long term care facilities with approximately 120 elders in Kaohsiung will be recruited and randomly assigned based on the resided facilities to a SEB experimental group or a waiting-list control group. The subjects in the experimental group will receive the SEB interventions lead by the certified instructors, three times per week, 40 minutes per practice for six months; the subjects in the waiting-list control group will remain regular daily activities in the facilities. All subjects will receive one pre-test and two post-tests three months apart during the study. In the third year, the elderly participants will continue practicing the SEB guided by a VCD for another nine months, and the compliance of the participants toward regular SEB exercise and its long-term effects on the physical functional fitness and sleep quality outcomes will be tested with additional three post-tests, three months apart.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wheelchair-bound Senior Elastic Band | Experimental | Other: Wheelchair-bound Senior Elastic Band exercise programWSEB interventions 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 (5 listed)
- elderly residents aged 65 and over
- Mandarin or Taiwanese speakers
- have been living in the facility for at least 3 months
- able to stand alone without assistive devices
- cognitively alert and able to verbally state their name, address, and answer questions.
Key exclusion criteria (1 listed)
- participants with severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses
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 programthree times per week, 40 minutes per practice | Other | Wheelchair-bound Senior Elastic Band |
Primary outcome
Change from baseline in physical functional fitness at 3, 6, 9, 12, 15 months
Time frame: participants will be followed for 15 months
including cardiovascular-respiratory function, body flexibility, muscle power/muscle endurance, and balance
2 secondary outcomes
Change from baseline in sleep quality 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
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 17 Jun 2014.
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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 in people with Institutional Older Adults, 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 5 inclusion and 1 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 17 Jun 2014. 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 physical 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?
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 17 Jun 2014.