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

NCT ID: NCT02164617

Last Updated: 2015-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-06-30

Brief 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.

Detailed 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.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Wheelchair-bound Senior Elastic Band

Wheelchair-bound Senior Elastic Band (WSEB) exercise program has three phases: 1) warm-up: 6 movements to loosen up the body and elevate the energy for a safe transition to the next phase, 2) aerobic motions: 6 low-to-medium speed exercises to enhance the cardiovascular-respiratory workout, and 3) static stretching: 6 low-speed, gentle stretching exercises to build up muscle power/endurance and increase range of motion and flexibility. It is conducted three times per week, 40 minutes per practice.

Group Type: EXPERIMENTAL

Wheelchair-bound Senior Elastic Band exercise program (WSEB)

Intervention Type: OTHER

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

control

routine care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Wheelchair-bound Senior Elastic Band exercise program (WSEB)

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Kaohsiung Medical University

OTHER

Sponsor Role: lead

Responsible Party

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

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kuei-Min Chen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Locations

Kaohsiung Medical University

Kaohsiung City, , Taiwan

Countries

Taiwan

References

Chen MC, Chen KM, Chang CL, Chang YH, Cheng YY, Huang HT. Elastic Band Exercises Improved Activities of Daily Living and Functional Fitness of Wheelchair-bound Older Adults with Cognitive Impairment: A Cluster Randomized Controlled Trial. Am J Phys Med Rehabil. 2016 Nov;95(11):789-799. doi: 10.1097/PHM.0000000000000518.

Reference Type: DERIVED

PMID: 27149585 (View on PubMed)

Other Identifiers

NSC-102-2314-B-037-054-MY2

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KMUHIRB-2012-01-02(II)

Identifier Type: -

Identifier Source: org_study_id