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

Dementia Clinical Trial

— WSEB  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164617
• Other study ID #: KMUHIRB-2012-01-02(II)
• Secondary ID: NSC-102-2314-B-0
• Status: Completed
• Phase: N/A
• First received: June 10, 2014
• Last updated: June 13, 2015
• Start date: March 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Kaohsiung Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: National Science Council
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dementia

Intervention

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

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Medical University	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in functional fitness at 3, 6, 9, 12, 15 months	1. 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	participants will be followed for 15 months	No
Secondary	Change from baseline in daily life function at 3, 6, 9, 12, 15 months	measured by Barthel Index (BI)	participants will be followed for 15 months	No
Secondary	Change from baseline in depression at 3, 6, 9, 12, 15 months	measured by Cornell Scale for Depression in Dementia Chinese version (CSDD)	participants will be followed for 15 months	No
Secondary	Change from baseline in problem behaviors at 3, 6, 9, 12, 15 months	Clifton Assessment Procedures for the Elderly-Behavior Rating Scale Chinese version (CAPE-BRS)	participants will be followed for 15 months	No