Elderly ResidentsNCT02271308
The Effects of Low Resistance Training on the Residents in Nursing Homes
A study testing Low-resistance elastic band training in people with Elderly Residents, run by Chang Bing Show Chwan Memorial Hospital at 1 site in Taiwan.
Trial summary
This study will examine the effects of low-resistance elastic band training on muscle strength, flexibility, quality of life and ease of care among the residents in nursing homes. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly Residents
- What is being tested?
- Low-resistance elastic band training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2014to Feb 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- living in nursing home over 3 months
- communicating with Mandarin and Taiwanese
- being able to sit in a chair or wheelchair
- can grip elastic band by hands
- consciousness intact and their consent to participate in this study
Who cannot join
- severe cardiovascular disease, musculoskeletal disorders and mental illness
Trial locations and contacts
1 site in 1 country.
Shu-Hui Yeh, PhD. contact
Taiwan1 site, 1 recruiting
- Recruiting
Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
Changhua County
Shu-Hui Yeh, PhD, yehshuhui@gmail.com
About this study
Official title: The Effects of Low Resistance Training Using Elastic Band on Muscle Strength, Flexibility, Quality of Life and Ease of Care in Nursing Home Residents: A Pilot Study
This study will examine the effects of low-resistance elastic band training on muscle strength, flexibility, quality of life and ease of care among the residents in nursing homes.
Read the detailed description
Regular exercise and dynamic life style can prevent and treat disability, as well as promote mental health and quality of life. In addition to chronic illness, reduced muscle mass and strength as part of aging, affect the daily activities of living of the elderly and their independent lifestyle. In fact, exercise had found positive effects on lower limb weakness of the elderly. Elastic band is a resistance training aid which can be used for different muscle weight training. The research results have been demonstrated elastic band resistance training is safe and effective strategy to apply in the elderly population and to improve physical fitness, and mental functioning. Therefore, this study will examine the effects of low-resistance elastic band training on muscle strength, flexibility, quality of life and ease of care among the nursing home residents. Nursing homes with more than 50 beds that will be recruited in Qingshui and Waipu district Taichung City. Nursing homes will be randomly assigned to the experimental group and the comparison group. Each group has 20 subjects. The residents in experimental group will receive a low-resistance elastic band training(30 minutes), including warm-up and cold-down period, three times per week for 10 weeks. Residents in control group will receive regular activity in nursing home. Inclusion criteria for the elderly include: (1) living in nursing home over 3 months; (2) communicating with Mandarin and Taiwanese; (3) being able to sit in a chair or wheelchair; (4) can grip elastic band by hands; (5) no severe cardiovascular disease, musculoskeletal disorders and mental illness;(6) consciousness intact and their consent to participate in this study. Two structured questionnaires and an assessment checklist of muscle strength, flexibility will be used to collect data at baseline, week 8 and week 12 of exercise. The collected data will be coded and double checked and analyzed by using SPSS Window Release 20.0. The findings of this study can be apply to develop and conduct an effective exercise program through elastic band resistance training to improve residents' strength, flexibility, quality of life and care of ease in Taiwan.
- Conditions
- Elderly Residents
- Being tested
- Low-resistance elastic band training
- Keywords
- elastic band resistance training, nursing home residents, muscle strength, flexibility, quality of life, ease of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-resistance elastic band trainingBehavioural
The residents in experimental group will receive a low-resistance elastic band training (30 minutes), including warm-up and cold-down period, three times per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Residents in control group will receive regular activity in nursing homes. |
| Experimental group | Experimental | The residents in experimental group will receive a low-resistance elastic band training (30 minutes), including warm-up and cold-down period, three times per week for 12 weeks. Receives: Behavioral: Low-resistance elastic band training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve muscle strength
Muscle strength will be assessed using hand-held dynameter at 3 different times: (1) baseline data: before low-resistance elastic band training, (2) outcome data: at 8 and 12 weeks post-test.
Measured: Change from baseline in muscle strength at 3 months
Secondary outcomes (4)
Improve body flexibility
Body flexibility will be assessed at 3 different times: (1) baseline data: before low-resistance elastic band training, (2) outcome data: at 8 and 12 weeks post-test.
Measured: Change from baseline in Body flexibility at 3 months
Improve life quality
Life quality will be assessed by SF-12 questionnaire（Short Form-12 Items Health Survey,SF-12）at 3 different times: (1) baseline data: before low-resistance elastic band training, (2) outcome data: at 8 and 12 weeks post-test.
Measured: Change from baseline in life quality at 3 months
Improve quality of care
Quality of care will be assessed by ease-of-care inventory (Yan、Wu、 Lin and Lin, 2007) at at three different times: (1) baseline data :before low-resistance elastic band training, (2) outcome data: at 8 and 12 weeks post-test.
Measured: Change from baseline in quality of care at 3 months
Basic attribute data
Subjects will fill out questionnaire including blood pressure, pulse, activity, respiration, pain, ADL (Barthel Index), weight, thickness of subcutaneous fat and body mass index (BMI).
Measured: Change from baseline in basic attribute data at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly ResidentsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Bing Show Chwan Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Hui Yeh, Chang Bing Show Chwan Memorial Hospital
- Investigators
- Li-Wei Lin, PhD., Principal investigator, Department of Nursing, Hung Kuang UniversityShu-Hui Yeh, PhD., Principal investigator, Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271308
- Sponsor's protocol ID
- 1030109
- Status last verified
- Oct 2014
- First submitted
- 14 Oct 2014
- Last updated
- 22 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Low Resistance Training Using Elastic Band on Muscle Strength, Flexibility, Quality of Life and Ease of Care in Nursing Home Residents: A Pilot Study
- ClinicalTrials.gov ID
- NCT02271308
- Acronym / sponsor ID
- 1030109
- Conditions
- Elderly Residents
- Keywords
- elastic band resistance training, nursing home residents, muscle strength, flexibility, quality of life, ease of care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Bing Show Chwan Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 22 Oct 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.
This study will examine the effects of low-resistance elastic band training on muscle strength, flexibility, quality of life and ease of care among the residents in nursing homes.
Detailed description
Regular exercise and dynamic life style can prevent and treat disability, as well as promote mental health and quality of life. In addition to chronic illness, reduced muscle mass and strength as part of aging, affect the daily activities of living of the elderly and their independent lifestyle. In fact, exercise had found positive effects on lower limb weakness of the elderly. Elastic band is a resistance training aid which can be used for different muscle weight training. The research results have been demonstrated elastic band resistance training is safe and effective strategy to apply in the elderly population and to improve physical fitness, and mental functioning. Therefore, this study will examine the effects of low-resistance elastic band training on muscle strength, flexibility, quality of life and ease of care among the nursing home residents. Nursing homes with more than 50 beds that will be recruited in Qingshui and Waipu district Taichung City. Nursing homes will be randomly assigned to the experimental group and the comparison group. Each group has 20 subjects. The residents in experimental group will receive a low-resistance elastic band training(30 minutes), including warm-up and cold-down period, three times per week for 10 weeks. Residents in control group will receive regular activity in nursing home. Inclusion criteria for the elderly include: (1) living in nursing home over 3 months; (2) communicating with Mandarin and Taiwanese; (3) being able to sit in a chair or wheelchair; (4) can grip elastic band by hands; (5) no severe cardiovascular disease, musculoskeletal disorders and mental illness;(6) consciousness intact and their consent to participate in this study. Two structured questionnaires and an assessment checklist of muscle strength, flexibility will be used to collect data at baseline, week 8 and week 12 of exercise. The collected data will be coded and double checked and analyzed by using SPSS Window Release 20.0. The findings of this study can be apply to develop and conduct an effective exercise program through elastic band resistance training to improve residents' strength, flexibility, quality of life and care of ease in Taiwan.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Residents in control group will receive regular activity in nursing homes. |
| Experimental group | Experimental | Behavioral: Low-resistance elastic band trainingThe residents in experimental group will receive a low-resistance elastic band training (30 minutes), including warm-up and cold-down period, three times per week for 12 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- living in nursing home over 3 months
- communicating with Mandarin and Taiwanese
- being able to sit in a chair or wheelchair
- can grip elastic band by hands
- consciousness intact and their consent to participate in this study
Key exclusion criteria (1 listed)
- severe cardiovascular disease, musculoskeletal disorders and mental illness
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 |
|---|---|---|
| Low-resistance elastic band trainingThe residents in experimental group will receive a low-resistance elastic band training (30 minutes), including warm-up and cold-down period, three times per week for 12 weeks. | Behavioural | Experimental group |
Primary outcome
Improve muscle strength
Time frame: Change from baseline in muscle strength at 3 months
Muscle strength will be assessed using hand-held dynameter at 3 different times: (1) baseline data: before low-resistance elastic band training, (2) outcome data: at 8 and 12 weeks post-test.
4 secondary outcomes
Improve body flexibility
Time frame: Change from baseline in Body flexibility at 3 months
Improve life quality
Time frame: Change from baseline in life quality at 3 months
Improve quality of care
Time frame: Change from baseline in quality of care at 3 months
Basic attribute data
Time frame: Change from baseline in basic attribute data at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 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.
Shu-Hui Yeh, PhD. contact
Li-Wei Lin, PhD. principal investigator
Department of Nursing, Hung Kuang University
Shu-Hui Yeh, PhD. principal investigator
Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-resistance elastic band training in people with Elderly Residents, run by Chang Bing Show Chwan Memorial Hospital 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: status not confirmed, as of the sponsor's last update on 22 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Hui Yeh, PhD. (yehshuhui@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve muscle strength (time frame: Change from baseline in muscle strength at 3 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 22 Oct 2014.