NCT02271308

Brief Summary

This study will examine the effects of low-resistance elastic band training on muscle strength, flexibility, quality of life and ease of care among the residents in nursing homes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
unknown

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
8 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

October 22, 2014

Status Verified

October 1, 2014

Enrollment Period

11 months

First QC Date

October 14, 2014

Last Update Submit

October 21, 2014

Conditions

Keywords

elastic band resistance trainingnursing home residentsmuscle strengthflexibilityquality of lifeease of care

Outcome Measures

Primary Outcomes (1)

  • Improve muscle strength

    Muscle strength will be assessed using hand-held dynameter at 3 different times: (1) baseline data: before low-resistance elastic band training, (2) outcome data: at 8 and 12 weeks post-test.

    Change from baseline in muscle strength at 3 months

Secondary Outcomes (4)

  • Improve body flexibility

    Change from baseline in Body flexibility at 3 months

  • Improve life quality

    Change from baseline in life quality at 3 months

  • Improve quality of care

    Change from baseline in quality of care at 3 months

  • Basic attribute data

    Change from baseline in basic attribute data at 3 months

Study Arms (2)

Control group

NO INTERVENTION

Residents in control group will receive regular activity in nursing homes.

Experimental group

EXPERIMENTAL

The residents in experimental group will receive a low-resistance elastic band training (30 minutes), including warm-up and cold-down period, three times per week for 12 weeks.

Behavioral: Low-resistance elastic band training

Interventions

The residents in experimental group will receive a low-resistance elastic band training (30 minutes), including warm-up and cold-down period, three times per week for 12 weeks.

Experimental group

Eligibility Criteria

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

You may qualify if:

  • living in nursing home over 3 months
  • communicating with Mandarin and Taiwanese
  • being able to sit in a chair or wheelchair
  • can grip elastic band by hands
  • consciousness intact and their consent to participate in this study

You may not qualify if:

  • severe cardiovascular disease, musculoskeletal disorders and mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital

Changhua County, Taiwan

RECRUITING

Study Officials

  • Li-Wei Lin, PhD.

    Department of Nursing, Hung Kuang University

    PRINCIPAL INVESTIGATOR
  • Shu-Hui Yeh, PhD.

    Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Hui Yeh, PhD.

CONTACT

Study Design

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

Study Record Dates

First Submitted

October 14, 2014

First Posted

October 22, 2014

Study Start

March 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

October 22, 2014

Record last verified: 2014-10

Locations