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

NCT05209685 | Completed

• 1 other identifier: A-BR-110-075
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frailty

Keywords

pre-frail, blood flow restriction, functional mobility

Outcome Measures

Primary Outcomes (3)

• Change of Timed-Up and Go (TUG) test

  Timed-Up and Go test

  Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention

• Change of 30 seconds sit to stand

  30 seconds sit to stand test

  Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention

• Change of muscle strength of the lower extremities

  Muscle strength of bilateral hip flexors, knee extensors, ankle dorsiflexors and plantarflexors

  Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention

Secondary Outcomes (3)

• Change of one-repetition maximum

  Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention

• Change of muscle mass

  Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention

• Change of hand grip strength

  Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention

Study Arms (2)

Experimental

EXPERIMENTAL

Resistance exercise with blood flow restriction

Other: Resistance exercise on the lower extremities with blood flow restriction

Control

ACTIVE COMPARATOR

Traditional resistance exercise

Other: Resistance exercise on the lower extremities

Interventions

Resistance exercise on the lower extremities 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.

Control

Resistance exercise on the lower extremities with blood flow restriction OTHER

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

Experimental

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

Department of Physical Therapy

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 26, 2022
• Study Start: August 17, 2020
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)