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

Effect of Blood Flow Restriction Resistance Exercise on Functional Mobility in Pre-Frail Older Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05209685
Enrollment
54
Registered
2022-01-26
Start date
2020-08-17
Completion date
2022-12-31
Last updated
2023-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty

Keywords

pre-frail, blood flow restriction, functional mobility

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.

Interventions

OTHERResistance 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.

OTHERResistance 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.

Sponsors

National Cheng Kung University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of Timed-Up and Go (TUG) testBefore intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after interventionTimed-Up and Go test
Change of 30 seconds sit to standBefore intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention30 seconds sit to stand test
Change of muscle strength of the lower extremitiesBefore intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after interventionMuscle strength of bilateral hip flexors, knee extensors, ankle dorsiflexors and plantarflexors

Secondary

MeasureTime frameDescription
Change of one-repetition maximumBefore intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after interventionOne-repetiton maximum of side step-ups
Change of muscle massBefore intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after interventionMuscle mass of the upper and lower extremities and trunk
Change of hand grip strengthBefore intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after interventionBilateral grip strength

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026