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

Not Applicable

Completed

• Conditions: Frailty
• Interventions: Other: Resistance exercise on the lower extremities with blood flow restriction; Other: Resistance exercise on the lower extremities

• Registration Number: NCT05209685
• Lead Sponsor: National Cheng Kung University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-08-17
• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-01-26
• Primary Completion: 2022-10-31
• Study Completion: 2022-12-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Resistance exercise on the lower extremities with blood flow restriction	Resistance exercise with blood flow restriction
Control	Resistance exercise on the lower extremities	Traditional resistance exercise

Primary Outcome Measures

Name	Time	Method
Change of 30 seconds sit to stand	Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention	30 seconds sit to stand test
Change of muscle strength of the lower extremities	Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention	Muscle strength of bilateral hip flexors, knee extensors, ankle dorsiflexors and plantarflexors
Change of Timed-Up and Go (TUG) test	Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention	Timed-Up and Go test

Secondary Outcome Measures

Name	Time	Method
Change of muscle mass	Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention	Muscle mass of the upper and lower extremities and trunk
Change of one-repetition maximum	Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention	One-repetiton maximum of side step-ups
Change of hand grip strength	Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention	Bilateral grip strength

Trial Locations

Locations (1)

Department of Physical Therapy; 🇨🇳 Tainan, Taiwan