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Clinical Trials/NCT04507152
NCT04507152
Completed
Not Applicable

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

National Cheng Kung University1 site in 1 country26 target enrollmentAugust 5, 2020
ConditionsFrailty

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frailty
Sponsor
National Cheng Kung University
Enrollment
26
Locations
1
Primary Endpoint
Change of 30 seconds sit to stand
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 5, 2020
End Date
November 26, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pei-Yun Lee

Assistant professor

National Cheng Kung University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

  • Change of muscle mass(Before training, 3 and 6 weeks after training, and one and two months follow-ups)
  • Change of hand grip(Before training, 3 and 6 weeks after training, and one and two months follow-ups)
  • Change of one-repetition maximum(Before training, 3 and 6 weeks after training, and one and two months follow-ups)
  • Change of physical activity level(Before training, 3 and 6 weeks after training, and one and two months follow-ups)

Study Sites (1)

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