NCT05462015

Brief Summary

A lack of studies has applied elastic band resistance training exercises on hospitalized elderly, so the effect of elastic band resistance training exercises on physical fitness and risk of falls was unclear. Therefore, the purposes of this study were to investigate the effectiveness of elastic band resistance training on improving physical fitness and reducing the risk of falls in hospitalized elderly with high risk of falls. This study is an experimental study. The experimental group was given 3 times a week for 2 consecutive weeks of elastic band resistance training, while the control group was given regular rehabilitation exercises. The differences in physical fitness and fall risk between the two groups were examined.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

July 11, 2022

Last Update Submit

April 10, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • Functional Fitness Test

    Physical fitness is considered to be the comprehensive ability of the body to adapt to life and the environment; people with good physical fitness have good vitality and adaptability in daily life or work, physical activities or sports, and are not prone to fatigue or weakness; Ministry of Health and Welfare National Health Administration refers to the United States Scholars have designed functional fitness tests for the elderly over 60 years old, and developed domestic fitness tests to assess physical health. Topics include muscle strength and endurance, cardiorespiratory endurance, flexibility, agility, and homeostasis. Scholars in Taiwan conducted a reliability and validity study of the Taiwan version of the Fukang Scale for the elderly in a community in Taipei City, including 400 elderly people in the community, including 142 who had fallen experience. The degree of reliability is 0.97, and the between-group reliability is 0.996.

    first day

  • Functional Fitness Test

    Physical fitness is considered to be the comprehensive ability of the body to adapt to life and the environment; people with good physical fitness have good vitality and adaptability in daily life or work, physical activities or sports, and are not prone to fatigue or weakness; Ministry of Health and Welfare National Health Administration refers to the United States Scholars have designed functional fitness tests for the elderly over 60 years old, and developed domestic fitness tests to assess physical health. Topics include muscle strength and endurance, cardiorespiratory endurance, flexibility, agility, and homeostasis. Scholars in Taiwan conducted a reliability and validity study of the Taiwan version of the Fukang Scale for the elderly in a community in Taipei City, including 400 elderly people in the community, including 142 who had fallen experience. The degree of reliability is 0.97, and the between-group reliability is 0.996.

    one week

  • Functional Fitness Test

    Physical fitness is considered to be the comprehensive ability of the body to adapt to life and the environment; people with good physical fitness have good vitality and adaptability in daily life or work, physical activities or sports, and are not prone to fatigue or weakness; Ministry of Health and Welfare National Health Administration refers to the United States Scholars have designed functional fitness tests for the elderly over 60 years old, and developed domestic fitness tests to assess physical health. Topics include muscle strength and endurance, cardiorespiratory endurance, flexibility, agility, and homeostasis. Scholars in Taiwan conducted a reliability and validity study of the Taiwan version of the Fukang Scale for the elderly in a community in Taipei City, including 400 elderly people in the community, including 142 who had fallen experience. The degree of reliability is 0.97, and the between-group reliability is 0.996.

    completed through training, usually two weeks

  • Tw-FROP-Com

    Taiwan version of Falls Risk for Older People Community setting (Tw-FROP-Com) to evaluate risk factors associated with falls.in old adults. Falls in the old adults may not only cause physical and psychological harm, but also lead to death in severe cases, and may also increase medical costs. Taiwan introduced and fine-tuned the FROP-com scale designed by Russell et al. into the Taiwan version of the Fukang scale (TW-FROP-Com) to assess the risk of falls. The assessment contents include: fall experience, medication, medical conditions, whether Visual, somatosensory impairment, presence of foot or shoe problems, cognitive status, bladder control, nutritional status in the past three months and weight loss in the past year, environment, functional movements, activities of daily living (ADL) condition), walking balance, gait and activity; if the total score is more than 21 points, it is assessed as a high-risk group for falls.

    first day

  • Tw-FROP-Com

    Taiwan version of Falls Risk for Older People Community setting (Tw-FROP-Com) to evaluate risk factors associated with falls.in old adults. Falls in the old adults may not only cause physical and psychological harm, but also lead to death in severe cases, and may also increase medical costs. Taiwan introduced and fine-tuned the FROP-com scale designed by Russell et al. into the Taiwan version of the Fukang scale (TW-FROP-Com) to assess the risk of falls. The assessment contents include: fall experience, medication, medical conditions, whether Visual, somatosensory impairment, presence of foot or shoe problems, cognitive status, bladder control, nutritional status in the past three months and weight loss in the past year, environment, functional movements, activities of daily living (ADL) condition), walking balance, gait and activity; if the total score is more than 21 points, it is assessed as a high-risk group for falls.

    completed through training, usually two weeks

  • Tw-FROP-Com

    Taiwan version of Falls Risk for Older People Community setting (Tw-FROP-Com) to evaluate risk factors associated with falls.in old adults. Falls in the old adults may not only cause physical and psychological harm, but also lead to death in severe cases, and may also increase medical costs. Taiwan introduced and fine-tuned the FROP-com scale designed by Russell et al. into the Taiwan version of the Fukang scale (TW-FROP-Com) to assess the risk of falls. The assessment contents include: fall experience, medication, medical conditions, whether Visual, somatosensory impairment, presence of foot or shoe problems, cognitive status, bladder control, nutritional status in the past three months and weight loss in the past year, environment, functional movements, activities of daily living (ADL) condition), walking balance, gait and activity; if the total score is more than 21 points, it is assessed as a high-risk group for falls.

    one week

Study Arms (2)

Elastic band

EXPERIMENTAL

The experimental group received a 35-minute training course for 2 weeks, 3 times a week, each time during the hospitalization. A total of 4 assessments were performed: baseline (pre-intervention), after third-time intervention, post-intervention, and one week after the intervention.

Behavioral: elastic-band exercises

Control

ACTIVE COMPARATOR

The control group was given routine rehabilitation exercise

Behavioral: regular rehabilitation

Interventions

The training content includes 5 minutes of warm-up exercise, 20 minutes of elastic-band resistance training, and 10 minutes of cool-down exercise.

Also known as: resistance band exercises
Elastic band

The training content includes 5-minute warm-up exercise, 20-minute upper and lower extremity muscle strengthening, and 10-minute cool-down exercise

Control

Eligibility Criteria

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

You may qualify if:

  • Elders are over 65 years old and admitted to this medical ward due to acute/chronic disease
  • Elders have no physical impairment
  • Elders have a clear cognition, can follow movement commands in Chinese or Taiwanese
  • Elders have greater than 4 points in lower extremity muscle strength measured by the Manual Muscle Power Test
  • Elders have greater than 45 points in the Morse Fall Scale, which indicate a high risk of falling

You may not qualify if:

  • Unclear consciousness
  • Unable to follow the execution of elastic band resistance training
  • With restricted activities, musculoskeletal disorders, or nerve diseases
  • Unsuitable athletic trainers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 11, 2022

First Posted

July 18, 2022

Study Start

August 1, 2022

Primary Completion

February 28, 2023

Study Completion

March 31, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share