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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Frailty

Intervention / Treatment
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* Device: exercise training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a randomized, multi-arm parallel and controlled intervention study.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Barthel index | 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 | 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 | 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 | 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 | 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 | Test for quantifying functional mobility | Up to 6 months | 
| 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. | Up to 6 months | 
| Change of Color Trails Test | 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 | 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 | Test cognitive function, range from 0-30, higher values represent a greater outcome | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, frailty, physical function, mental function, aged