Senior Elastic Band (SEB) on Institutional Elders

NCT ID: NCT02165150

Last Updated: 2014-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-07-31

Brief Summary

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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

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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

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Institutional Older Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Wheelchair-bound Senior Elastic Band

WSEB interventions three times per week, 40 minutes per practice

Group Type EXPERIMENTAL

Wheelchair-bound Senior Elastic Band exercise program

Intervention Type OTHER

three times per week, 40 minutes per practice

Control

routine care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Wheelchair-bound Senior Elastic Band exercise program

three times per week, 40 minutes per practice

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* participants with severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

Kaohsiung Medical University

OTHER

Sponsor Role lead

Responsible Party

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Kuei-Min Chen, Ph.D., RN.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kuei-Min Chen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Locations

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Kaohsiung Medical University

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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NSC99-2628-B-037-066-MY3

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FYH-IRB-098-12-02

Identifier Type: -

Identifier Source: org_study_id

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