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Blood Flow Restriction Training in Pre-frail and Frail Older Adults

Effect of Blood Flow Restriction Resistance Training on Muscle Strength and Functional Performance in Frail Older Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04507152
Enrollment
26
Registered
2020-08-11
Start date
2020-08-05
Completion date
2021-11-26
Last updated
2022-01-11

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

Conditions

Frailty

Keywords

Blood flow restriction, Resistance exercise, Frailty

Brief summary

Frailty is most often defined as a syndrome of physiological decline in late life, characterized by marked vulnerability to adverse health outcomes. Intervention such as exercise, especially resistance exercise, has proven to be effective to improve frail condition in the elderly in the previous literature. However, blood flow restriction (BFR) training, a new resistance exercise training method, need merely lower resistance power and shorter training duration compared with traditional resistance exercise. Previous researches also demonstrated BFR can increase muscle mass and muscle strength in the healthy elderly but the effect of BFR training on the pre-frail or frail elderly is unknown. The aim of this study will test the effect of BFR training on muscle strength and functional performance in pre-frail or frail elderly. Participants aged over 60 years old with clinical frailty score between 3 to 5 will be recruited. Participants will be assigned to two groups using randomized block design with BFR training and control group. Structured questionnaire and physical function measurement will be used to assess the pre-intervention condition and outcome of different interventions. The participants will be assessed before training (pre-test), 3 weeks after training, and 6 weeks after training (post-test), and followed up at one and three months after training. Physical function measurement will include hand grip, muscle mass over trunk and extremity, muscle strength of lower extremity, gait speed and timed up and go test. Two-way repeated measures analysis of variance will be used to test the pre-test, 3-week, post-test and follow-ups difference between the two groups.

Interventions

The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The experimental group will execute the training with blood flow restriction.

OTHERResistance training

The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The control group will execute the training without blood flow restriction.

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
60 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

* Aged over 60 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 muscle strength of the lower extremitiesBefore training, 3 and 6 weeks after training, and one and two months follow-upsBilateral hip flexors, knee extensors, ankle dorsiflexors and ankle plantarflexors
Change of 30 seconds sit to standBefore training, 3 and 6 weeks after training, and one and two months follow-ups30 seconds sit to stand
Change of timed-up-and-go testBefore training, 3 and 6 weeks after training, and one and two months follow-upsTimed-up-and-go test

Secondary

MeasureTime frameDescription
Change of hand gripBefore training, 3 and 6 weeks after training, and one and two months follow-upsBilateral hand grip strength
Change of muscle massBefore training, 3 and 6 weeks after training, and one and two months follow-upsMuscle mass of the upper and lower extremities and trunk
Change of physical activity levelBefore training, 3 and 6 weeks after training, and one and two months follow-upsThe International Physical Activity Questionnaire (IPAQ)
Change of one-repetition maximumBefore training, 3 and 6 weeks after training, and one and two months follow-upsOne-repetition maximum of step-ups

Countries

Taiwan

Outcome results

None listed

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