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Completed

NCT Number: NCT04507152

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

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.

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Key information

Age range

60 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood flow restriction resistance training

Other

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.

Resistance training

Other

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.

Primary outcomes

  1. Change of muscle strength of the lower extremities

    Time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups

    Bilateral hip flexors, knee extensors, ankle dorsiflexors and ankle plantarflexors

  2. Change of 30 seconds sit to stand

    Time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups

    30 seconds sit to stand

  3. Change of timed-up-and-go test

    Time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups

    Timed-up-and-go test

Secondary outcomes

  1. Change of one-repetition maximum

    Time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups

    One-repetition maximum of step-ups

  2. Change of muscle mass

    Time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups

    Muscle mass of the upper and lower extremities and trunk

  3. Change of hand grip

    Time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups

    Bilateral hand grip strength

  4. Change of physical activity level

    Time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups

    The International Physical Activity Questionnaire (IPAQ)

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 11, 2020
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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