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

NCT ID: NCT05279625

Last Updated: 2022-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-12-01

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.

Conditions

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Frailty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Interval exercise training

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

Group Type EXPERIMENTAL

exercise training

Intervention Type DEVICE

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

continuous exercise training

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

Group Type EXPERIMENTAL

exercise training

Intervention Type DEVICE

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

machine-assisted exercise training

machine-assisted exercise training for 6 months

Group Type EXPERIMENTAL

exercise training

Intervention Type DEVICE

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

traditional rehabilitation

traditional rehabilitation for 6 months

Group Type ACTIVE_COMPARATOR

exercise training

Intervention Type DEVICE

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

Interventions

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exercise training

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

Intervention Type DEVICE

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wang-Sheng Lin, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Yilan, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Wang-Sheng Lin, MD

Role: CONTACT

+886-39222141

Facility Contacts

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Wang-Sheng Lin

Role: primary

886-39222141

Other Identifiers

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2021-10-014BCF

Identifier Type: -

Identifier Source: org_study_id

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