NCT02164617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 16, 2015

Status Verified

June 1, 2015

Enrollment Period

1.3 years

First QC Date

June 10, 2014

Last Update Submit

June 13, 2015

Conditions

Dementia

Keywords

DementiaWheelchair-bound seniorsLong-term care facilitiesElastic band exerciseFunctional fitnessDaily life functionDepressionProblem behaviors

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

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

    participants will be followed for 15 months

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

    participants will be followed for 15 months

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

    participants will be followed for 15 months

Study Arms (2)

Wheelchair-bound Senior Elastic Band

EXPERIMENTAL

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.

Other: Wheelchair-bound Senior Elastic Band exercise program (WSEB)

control

NO INTERVENTION

routine care

Interventions

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

Wheelchair-bound Senior Elastic Band

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, 80708, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 27149585DERIVED

MeSH Terms

Conditions

DementiaDepressionProblem Behavior

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavioral SymptomsBehaviorChild Behavior

Study Officials

  • Kuei-Min Chen, Ph.D.

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 16, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 16, 2015

Record last verified: 2015-06

Locations

TW(1)