Blood Flow Restriction on Functional Mobility in Pre-frail Older Adults

NCT ID: NCT05209685

Last Updated: 2023-11-27

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

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-17

Study Completion Date

2022-12-31

Brief Summary

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This study investigates the effect of blood flow restriction with resistance exercise on functional mobility in pre-frail older adults. It is hypothesized that receiving resistance exercise with blood flow restriction will exhibit better improvement on functional mobility than only receiving resistance exercise in pre-frail older adults.

Detailed Description

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Participants aged over 65 years old with less than two items positive of Fried frailty phenotype assessment result will be recruited. The participants will be randomly assigned to two training groups, blood flow restriction resistance exercise and traditional resistance exercise. Both groups will receive the training 30 minutes/session, two sessions/week for six weeks. Muscle strength of the lower extremities and functional mobility tests will be used to assess outcomes at pre-training, 3-week after training, post-training, and one-month and two-month follow-up.

Conditions

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Frailty

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

Resistance exercise with blood flow restriction

Group Type EXPERIMENTAL

Resistance exercise on the lower extremities with blood flow restriction

Intervention Type OTHER

Blood flow restriction on the thigh of the dominant leg will be used in combination with resistance exercise.

Control

Traditional resistance exercise

Group Type ACTIVE_COMPARATOR

Resistance exercise on the lower extremities

Intervention Type OTHER

Resistance exercise mainly on the lower extremities will be executed by carrying weight according to each participant's tolerance while performing certain movements, such as side step-up, sit-to-stand, and tip-toe-standing.

Interventions

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Resistance exercise on the lower extremities

Resistance exercise mainly on the lower extremities will be executed by carrying weight according to each participant's tolerance while performing certain movements, such as side step-up, sit-to-stand, and tip-toe-standing.

Intervention Type OTHER

Resistance exercise on the lower extremities with blood flow restriction

Blood flow restriction on the thigh of the dominant leg will be used in combination with resistance exercise.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged over 65 years old
* Fried frailty index fulfill 1-2 criteria
* Able to walk 6 meters independently
* Able to understand and follow ≥ 3 instructions

Exclusion Criteria

* Severe hypertension (\>180/110mmHg)
* Peripheral neuropathy
* History of deep-vein thrombosis (DVT)
* Cardiovascular diseases (i.e. Heart failure NYHA Classification III or IV, myocardial infarction, pulmonary hypertension, coronary artery stenosis)
* Neuromuscular diseases (i.e. Stroke, Parkinsons' disease)
* History of resisted exercise training program within the last 6 months before screening
Minimum Eligible Age

65 Years

Maximum Eligible Age

95 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

Other Identifiers

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A-BR-110-075

Identifier Type: -

Identifier Source: org_study_id