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Blood Flow Restriction With Aerobic Exercise in Frail Older Adults

NCT ID: NCT06155227

Last Updated: 2023-12-26

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2025-12-31

Brief Summary

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Background:Frailty is most often defined as a syndrome of physiological decline in late life, characterized by marked vulnerability to adverse health outcomes. Exercise intervention including aerobic exercise training has been proven to be effective in improving aerobic capacity and frail condition in elderly. Recently a novel training method using blood flow restriction (BFR) combined with aerobic exercise has shown positive effects on muscles strength and physical function in healthy elderly. This training method only required lower exercise intensity compared with traditional aerobic exercise to observe improvement. However, it is still unclear whether aerobic exercise training combined with BFR could also improve aerobic capacity and physical function in frail older adults. Therefore, the aim of this study will be to investigate the effect of aerobic exercise combined with BFR on cardiopulmonary function and functional activities in frail older adults.

Method: This study will be an assessor-blind randomized controlled trial.Participants aged over 65 years old with more than one item positive of Fried frailty phenotype assessment results will be recruited from the hospital and nearby communities. The participants will be randomly assigned to one of two training groups, aerobic exercise with BFR and only aerobic exercise. The exercise will be executed 30 minutes/session, three sessions/week for six weeks. Cardiopulmonary function and performance of functional activities will be assessed at pre-training, 3 weeks after training, post-training, and 3- and 6-week follow-up.

Detailed Description

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Conditions

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Rehabilitation

Keywords

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Blood flow restriction Aerobic exercise Frailty Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental Group

Group Type EXPERIMENTAL

aerobic exercise combined with blood flow restriction

Intervention Type OTHER

aerobic exercise combined with blood flow restriction for 18 sessions

Control Group

Group Type ACTIVE_COMPARATOR

aerobic exercise

Intervention Type OTHER

aerobic exercise for 18 sessions

Interventions

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aerobic exercise combined with blood flow restriction

aerobic exercise combined with blood flow restriction for 18 sessions

Intervention Type OTHER

aerobic exercise

aerobic exercise for 18 sessions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* more than one positive item of Fried frailty phenotype assessment
* able to walk more than 8 meters independently
* can understand and follow more than three-step order

Exclusion Criteria

* severe hypertension (\>160/100 mmHg)
* cardiovascular disease, such as myocardial infarction, New York Heart Association class III or IV heart failure, pulmonary hypertension
* deep vein thrombosis or peripheral vascular disease
* peripheral neuropathy due to diabetes
* neuromuscular diseases, such as stroke, Parkinson's disease, etc.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng Kung University

OTHER

Sponsor Role lead

Responsible Party

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Pei-Yun Lee

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Physical Therapy

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Pei-Yun Lee, PhD

Role: CONTACT

Phone: 886-6-2353535

Email: [email protected]

Facility Contacts

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Pei-Yun Lee, PhD

Role: primary

Other Identifiers

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B-ER-112-370

Identifier Type: -

Identifier Source: org_study_id