Effects of Exercise Interventions in Frail Middle-aged and Older Adults

March 6, 2022 updated by: Taipei Veterans General Hospital, Taiwan
This study aimed to determine the ideal parameters of exercise program for frail middle-aged and older adults on physical and mental functions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Exercise has been suggested as a possible lifestyle intervention for improving physical and cognitive performance. Various training options depending on various physical circumstances will be presented. However, the ideal exercise protocol for frail middle-aged and older adults had the greater benefits remain unknown. In general, 3-6 months of frequent exercise can enhance physical and cognitive outcome.

The investigators conduct this multiple arm, prospective study to determine the ideal parameters of exercise program for frail middle-aged and older adults on physical and cognitive functions. This study designed to recruit 200 older adults with frailty. All the older adults will receive exercise training using either elastic band, dumbbells, machines, treadmill, cycling for 6 months. Outcome measures including a systematic evaluation for frail older persons using comprehensive geriatric assessment, as well as the assessments of physical and cognitive functions before and after interventions.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Yilan, Taiwan
        • Recruiting
        • Department of Physical Medicine & Rehabilitation, Taipei Veterans General Hospital, Yuan-Shan/Su-Ao Branch
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged above 50 years old with frailty syndrome

Exclusion Criteria:

  • Acute illnesses, such as unstable cardiac dysrhythmia, sepsis, or unstable vital signs
  • Physical or Cognitive issues that make it difficult for the patients to participate in our program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interval exercise training
Interval exercise training using either elastic band, dumbbells, treadmill, cycling for 6 months
Device: exercise training
using either elastic band, dumbbells, treadmill, cycling, machines for 6 months
Experimental: continuous exercise training
continuous exercise training using either elastic band, dumbbells, treadmill, cycling for 6 months
Device: exercise training
using either elastic band, dumbbells, treadmill, cycling, machines for 6 months
Experimental: machine-assisted exercise training
machine-assisted exercise training for 6 months
Device: exercise training
using either elastic band, dumbbells, treadmill, cycling, machines for 6 months
Active Comparator: traditional rehabilitation
traditional rehabilitation for 6 months
Device: exercise training
using either elastic band, dumbbells, treadmill, cycling, machines for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Barthel index
Time Frame: Up to 6 months
Test function of activities of daily living, range from 0-100, higher values represent a greater outcome.
Up to 6 months
Change of Montreal Cognitive Assessment
Time Frame: Up to 6 months
Test cognition including memory, attention, and language, range from 0-30, higher values represent a greater outcome
Up to 6 months
Change of Geriatric Depression Scale
Time Frame: Up to 6 months
Test depression status, , range from 0-15, higher values represent a worse outcome
Up to 6 months
Change of Lawton Instrumental Activities of Daily Living (IADL) Scale
Time Frame: Up to 6 months
To assesses a person's ability to perform tasks such as using a telephone, doing laundry, and handling finances.y. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent)
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Six-minute Walking Test
Time Frame: Up to 6 months
Test physical function. In healthy subjects, the 6-min walk distance ranges from 400 to 700 m.
Up to 6 months
Change of Timed Get-up-and-go Test
Time Frame: Up to 6 months
Test for quantifying functional mobility
Up to 6 months
Change of Memory span test
Time Frame: Up to 6 months
an examiner reads a list of random numbers aloud at about the rate of one number per second. At the end, the person being tested is asked to recall the items, in order.
Up to 6 months
Change of Color Trails Test
Time Frame: Up to 6 months
Test cognitive function. Test is scored by how long it takes to complete the test.
Up to 6 months
Change of Digit symbol substitution test
Time Frame: Up to 6 months
Test cognitive function. The test consists of filling as many empty boxes as possible with a symbol matching each number. The score is the number of correct number-symbol matches achieved.
Up to 6 months
Change of Mini-mental state examination
Time Frame: Up to 6 months
Test cognitive function, range from 0-30, higher values represent a greater outcome
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Wang-Sheng Lin, MD, Taipei Veterans General Hospital, Yuan-Shan/Su-Ao Branch, Yilan, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

March 6, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 6, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-10-014BCF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Frailty

Clinical Trials on exercise training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe