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

NCT05279625 | Unknown

• 1 other identifier: 2021-10-014BCF
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Keywords

exercise; frailty; physical function; mental function; aged

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Change of Six-minute Walking Test

  Up to 6 months

• Change of Timed Get-up-and-go Test

  Up to 6 months

• Change of Memory span test

  Up to 6 months

• Change of Color Trails Test

  Up to 6 months

• Change of Digit symbol substitution test

  Up to 6 months

Study Arms (4)

Interval exercise training

EXPERIMENTAL

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

Device: exercise training

continuous exercise training

EXPERIMENTAL

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

Device: exercise training

machine-assisted exercise training

EXPERIMENTAL

machine-assisted exercise training for 6 months

Device: exercise training

traditional rehabilitation

ACTIVE COMPARATOR

traditional rehabilitation for 6 months

Device: exercise training

Interventions

exercise training DEVICE

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

Interval exercise training; continuous exercise training; machine-assisted exercise training; traditional rehabilitation

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged above 50 years old with frailty syndrome

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

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

Yilan, Taiwan

RECRUITING

MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Wang-Sheng Lin, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang-Sheng Lin, MD

CONTACT

+886-39222141; a8889bms47@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: March 15, 2022
• Study Start: December 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 1, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)