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Completed

NCT Number: NCT02165150

Senior Elastic Band (SEB) on Institutional Elders

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University

Kaohsiung City, 80708, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wheelchair-bound Senior Elastic Band exercise program

Other

three times per week, 40 minutes per practice

Primary outcomes

  1. 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

  1. Change from baseline in sleep quality at 3, 6, 9, 12, 15 months

    Time frame: participants will be followed for 15 months

    measured by PSQI

  2. Change from baseline in depression at 3, 6, 9, 12, 15 months

    Time frame: participants will be followed for 15 months

    measured by Taiwanese Depression Questionnaire (TDQ)

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

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

Acronym: SEB

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 17, 2014
Registry last updated
Jun 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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