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Clinical Trials/NCT02165150
NCT02165150CompletedNot Applicable

Development, Application , and Evaluation of the Senior Elastic Band (SEB) Exercise Program for Elderly Residents in Long-term Care Facilities

Kaohsiung Medical University1 site in 1 country127 target enrollmentStarted: August 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
127
Locations
1
Primary Endpoint
Change from baseline in physical functional fitness at 3, 6, 9, 12, 15 months

Study Overview

Brief 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 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Wheelchair-bound Senior Elastic Band

Experimental

WSEB interventions three times per week, 40 minutes per practice

Intervention: Wheelchair-bound Senior Elastic Band exercise program (Other)

Control

No Intervention

routine care

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change from baseline in sleep quality at 3, 6, 9, 12, 15 months(participants will be followed for 15 months)
  • Change from baseline in depression at 3, 6, 9, 12, 15 months(participants will be followed for 15 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

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

Professor

Kaohsiung Medical University

Study Sites (1)

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