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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Changhua County, Taiwan
        • Recruiting
        • Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Low-resistance elastic band training
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Change from baseline in muscle strength at 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Change from baseline in Body flexibility at 3 months
Improve life quality
Time Frame: Change from baseline in life quality at 3 months
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.
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
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.
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
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).
Change from baseline in basic attribute data at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Bing Show Chwan Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings