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

Primary Purpose

Frailty

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

exercise training

About this trial

This is an interventional treatment trial for Frailty focused on measuring exercise, frailty, physical function, mental function, aged

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Physical Medicine & Rehabilitation, Taipei Veterans General Hospital, Yuan-Shan/Su-Ao BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Interval exercise training

continuous exercise training

machine-assisted exercise training

traditional rehabilitation

Arm Description

Interval exercise training using either elastic band, dumbbells, treadmill, cycling for 6 months

continuous exercise training using either elastic band, dumbbells, treadmill, cycling for 6 months

machine-assisted exercise training for 6 months

traditional rehabilitation for 6 months

Outcomes

Primary Outcome Measures

Change of Barthel index

Test function of activities of daily living, range from 0-100, higher values represent a greater outcome.

Change of Montreal Cognitive Assessment

Test cognition including memory, attention, and language, range from 0-30, higher values represent a greater outcome

Change of Geriatric Depression Scale

Test depression status, , range from 0-15, higher values represent a worse outcome

Change of Lawton Instrumental Activities of Daily Living (IADL) Scale

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)

Secondary Outcome Measures

Change of Six-minute Walking Test

Test physical function. In healthy subjects, the 6-min walk distance ranges from 400 to 700 m.

Change of Timed Get-up-and-go Test

Test for quantifying functional mobility

Change of Memory span test

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.

Change of Color Trails Test

Test cognitive function. Test is scored by how long it takes to complete the test.

Change of Digit symbol substitution test

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.

Change of Mini-mental state examination

Test cognitive function, range from 0-30, higher values represent a greater outcome

Full Information

NCT ID

NCT05279625

First Posted

January 25, 2022

Last Updated

March 6, 2022

Sponsor

Taipei Veterans General Hospital, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT05279625

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2021 (Actual)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study aimed to determine the ideal parameters of exercise program for frail middle-aged and older adults on physical and mental functions.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Frailty

Keywords

exercise, frailty, physical function, mental function, aged

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

a randomized, multi-arm parallel and controlled intervention study.

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Interval exercise training

Arm Type

Experimental

Arm Description

Interval exercise training using either elastic band, dumbbells, treadmill, cycling for 6 months

Arm Title

continuous exercise training

Arm Type

Experimental

Arm Description

continuous exercise training using either elastic band, dumbbells, treadmill, cycling for 6 months

Arm Title

machine-assisted exercise training

Arm Type

Experimental

Arm Description

machine-assisted exercise training for 6 months

Arm Title

traditional rehabilitation

Arm Type

Active Comparator

Arm Description

traditional rehabilitation for 6 months

Intervention Type

Device

Intervention Name(s)

exercise training

Intervention Description

using either elastic band, dumbbells, treadmill, cycling, machines for 6 months

Primary Outcome Measure Information:

Title

Change of Barthel index

Description

Test function of activities of daily living, range from 0-100, higher values represent a greater outcome.

Time Frame

Up to 6 months

Title

Change of Montreal Cognitive Assessment

Description

Test cognition including memory, attention, and language, range from 0-30, higher values represent a greater outcome

Time Frame

Up to 6 months

Title

Change of Geriatric Depression Scale

Description

Test depression status, , range from 0-15, higher values represent a worse outcome

Time Frame

Up to 6 months

Title

Change of Lawton Instrumental Activities of Daily Living (IADL) Scale

Description

Time Frame

Up to 6 months

Secondary Outcome Measure Information:

Title

Change of Six-minute Walking Test

Description

Test physical function. In healthy subjects, the 6-min walk distance ranges from 400 to 700 m.

Time Frame

Up to 6 months

Title

Change of Timed Get-up-and-go Test

Description

Test for quantifying functional mobility

Time Frame

Up to 6 months

Title

Change of Memory span test

Description

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.

Time Frame

Up to 6 months

Title

Change of Color Trails Test

Description

Test cognitive function. Test is scored by how long it takes to complete the test.

Time Frame

Up to 6 months

Title

Change of Digit symbol substitution test

Description

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.

Time Frame

Up to 6 months

Title

Change of Mini-mental state examination

Description

Test cognitive function, range from 0-30, higher values represent a greater outcome

Time Frame

Up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wang-Sheng Lin, MD

Phone

+886-39222141

a8889bms47@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wang-Sheng Lin, MD

Organizational Affiliation

Taipei Veterans General Hospital, Yuan-Shan/Su-Ao Branch, Yilan, Taiwan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Physical Medicine & Rehabilitation, Taipei Veterans General Hospital, Yuan-Shan/Su-Ao Branch

City

Yilan

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wang-Sheng Lin

Phone

886-39222141

a8889bms47@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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