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

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05279625
• Other study ID #: 2021-10-014BCF
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: March 2022
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Wang-Sheng Lin, MD
• Phone: +886-39222141
• Email: a8889bms47[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Frailty

Intervention

Device:
• exercise training
using either elastic band, dumbbells, treadmill, cycling, machines for 6 months

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine & Rehabilitation, Taipei Veterans General Hospital, Yuan-Shan/Su-Ao Branch	Yilan

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change of Geriatric Depression Scale	Test depression status, , range from 0-15, higher values represent a worse outcome	Up to 6 months
Primary	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	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
Secondary	Change of Timed Get-up-and-go Test	Test for quantifying functional mobility	Up to 6 months
Secondary	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
Secondary	Change of Color Trails Test	Test cognitive function. Test is scored by how long it takes to complete the test.	Up to 6 months
Secondary	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
Secondary	Change of Mini-mental state examination	Test cognitive function, range from 0-30, higher values represent a greater outcome	Up to 6 months