Senior Elastic Band (SEB) on Institutional Elders (SEB)

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

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.

Study Overview

• Status: Completed
• Conditions: Institutional Older Adults
• Intervention / Treatment: Other: Wheelchair-bound Senior Elastic Band exercise program

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 Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 80708
    • Kaohsiung Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wheelchair-bound Senior Elastic Band; WSEB interventions three times per week, 40 minutes per practice	Other: Wheelchair-bound Senior Elastic Band exercise program; three times per week, 40 minutes per practice
No Intervention: Control; routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in physical functional fitness at 3, 6, 9, 12, 15 months	including cardiovascular-respiratory function, body flexibility, muscle power/muscle endurance, and balance	participants will be followed for 15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in sleep quality at 3, 6, 9, 12, 15 months	measured by PSQI	participants will be followed for 15 months
Change from baseline in depression at 3, 6, 9, 12, 15 months	measured by Taiwanese Depression Questionnaire (TDQ)	participants will be followed for 15 months

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University
• Collaborators: National Science Council, Taiwan
• Investigators: Principal Investigator: Kuei-Min Chen, Ph.D., Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimate): June 17, 2014

Study Record Updates

• Last Update Posted (Estimate): June 17, 2014
• Last Update Submitted That Met QC Criteria: June 13, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Depression; Sleep Quality; Functional Fitness; Elastic Band; Institutional Elders
• Other Study ID Numbers: FYH-IRB-098-12-02; NSC99-2628-B-037-066-MY3 (Other Grant/Funding Number: National Science Council)