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Completed

NCT Number: NCT02164617

Wheelchair-bound Senior Elastic Band (WSEB) Exercise Program for the Demented Seniors

The goals of this three-year research project were: 1) to develop and evaluate the feasibility of the Wheelchair-bound Senior Elastic Band (WSEB) for the demented, wheelchair-bound seniors in long-term care facilities, 2) to evaluate the long-term effects of the instructor-led WSEB on the functional fitness, daily life function, depression, and problem behaviors of this senior population, and 3) to test the feasibility, compliance, and effectiveness of the DVD-led WSEB on this senior population.

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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 was applied. First Year (Phase I): A preliminary WSEB, including hard copy descriptions and DVD demonstrations of each exercise, were sent to the 12 experts in the Delphi advisory panel for their critique and evaluation. First Year (Phase II): A quasi-experimental, one-group, pretest-posttest design was used to pilot-test the feasibility of the WSEB on a group of 15-20 demented, wheelchair-bound seniors in long-term care facilities. Second Year: A quasi-experimental, pre-post tests, non-equivalent control group design was used to test the long-term effects of the instructor-led WSEB on the functional fitness (cardiovascular-respiratory function, body flexibility, range of the joint's motion, and muscle strength and endurance), daily life function, depression, and problem behaviors of the demented, wheelchair-bound seniors in long-term care facilities. Eight long-term care facilities with 150 demented, wheelchair-bound seniors from southern Taiwan were recruited and randomly assigned based on the facilities to a WSEB experimental group or a waiting-list control group. Participants in the experimental group received the WSEB lead by the pre-trained and certified instructors, three times per week, 40 minutes per practice for 24 weeks; participants in the waiting-list control group remained regular activities in the facilities. One pre-test and two post-tests, 12 weeks apart, were conducted. Third Year: Using the same method as in the second year, participants from the second year were continued practicing the WSEB, but guided by a DVD, for another 36 weeks. The feasibility, compliance, and effectiveness of the DVD-led WSEB on the demented, wheelchair-bound seniors in long-term care facilities were tested, and another three post-tests, 12 weeks apart, were conducted on the same outcome measurements as in the second year.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • aged 65 and over
  • diagnosed with dementia by a physician or screened by the Mini-Mental State Examination (MMSE) as dementia
  • wheelchair-bound seniors
  • living in the long-term care facility for at least three months

Exclusion criteria

  • having severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses
  • suffering from spinal cord injury with no rehabilitation potential

Treatment and study plan

Wheelchair-bound Senior Elastic Band exercise program (WSEB)

Other

Wheelchair-bound Senior Elastic Band exercise program (WSEB) three times per week, 40 minutes per practice

Primary outcomes

  1. Change from baseline in functional fitness at 3, 6, 9, 12, 15 months

    Time frame: participants will be followed for 15 months

    • Functional Fitness 1.1 Cardiovascular-Respiratory Function 1.1.1 Blood Pressure Digital Sphygmomanometer (OMRON - HEM707) 1.1.2 Lung Capacity TruZoneTM Peak Flow Meter 1.2 Body Flexibility 1.2.1 Upper Body Flexibility Back Scratch Test 1.2.2 Lower Body Flexibility Chair Sit-and-Reach Test 1.3 Range of the Joint's Motion 1.3.1 Flexion of the Shoulder Joint Goniometry 1.3.2 Abduction of the Shoulder Joint Goniometry 1.4 Muscle Strength and Endurance 1.4.1 Hand-Grip Strength Digital Handgrip Dynamometer (TKK - 5101) 1.4.2 Arm Muscle Endurance Arm Curl Test

Secondary outcomes

  1. Change from baseline in daily life function at 3, 6, 9, 12, 15 months

    Time frame: participants will be followed for 15 months

    measured by Barthel Index (BI)

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

    Time frame: participants will be followed for 15 months

    measured by Cornell Scale for Depression in Dementia Chinese version (CSDD)

  3. Change from baseline in problem behaviors at 3, 6, 9, 12, 15 months

    Time frame: participants will be followed for 15 months

    Clifton Assessment Procedures for the Elderly-Behavior Rating Scale Chinese version (CAPE-BRS)

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

Development and Evaluation of an Evidence-based Intervention Guideline of the Wheelchair-bound Senior Elastic Band (WSEB) Exercise Program for the Demented Seniors in Long-term Care Facilities

Acronym: WSEB

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 16, 2014
Registry last updated
Jun 16, 2015

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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