- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02271308
The Effects of Low Resistance Training on the Residents in Nursing Homes
October 21, 2014 updated by: Shu-Hui Yeh, Chang Bing Show Chwan Memorial Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
40
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 Contact
- Name: Shu-Hui Yeh, PhD.
- Email: yehshuhui@gmail.com
Study Locations
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Changhua County, Taiwan
- Recruiting
- Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
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Contact:
- Shu-Hui Yeh, PhD
- Email: yehshuhui@gmail.com
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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:
- 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
Exclusion Criteria:
- severe cardiovascular disease, musculoskeletal disorders and mental illness
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
Residents in control group will receive regular activity in nursing homes.
|
|
Experimental: Experimental group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Change from baseline in muscle strength at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improve body flexibility
Time Frame: Change from baseline in Body flexibility at 3 months
|
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.
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Change from baseline in Body flexibility at 3 months
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Improve life quality
Time Frame: Change from baseline in life quality at 3 months
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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.
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Change from baseline in life quality at 3 months
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Improve quality of care
Time Frame: Change from baseline in quality of care at 3 months
|
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.
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Change from baseline in quality of care at 3 months
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Basic attribute data
Time Frame: Change from baseline in basic attribute data at 3 months
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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).
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Change from baseline in basic attribute data at 3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Li-Wei Lin, PhD., Department of Nursing, Hung Kuang University
- Principal Investigator: Shu-Hui Yeh, PhD., Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology
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 (Anticipated)
February 1, 2015
Study Completion (Anticipated)
February 1, 2015
Study Registration Dates
First Submitted
October 14, 2014
First Submitted That Met QC Criteria
October 21, 2014
First Posted (Estimate)
October 22, 2014
Study Record Updates
Last Update Posted (Estimate)
October 22, 2014
Last Update Submitted That Met QC Criteria
October 21, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1030109
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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