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

N

National Cheng Kung University

Status

Completed

Conditions

Frailty

Treatments

Other: Blood flow restriction resistance training
Other: Resistance training

Study type

Interventional

Funder types

Other

Identifiers

NCT04507152
A-BR-108-111-T

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

60 to 95 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

26 participants in 2 patient groups

Blood flow restriction resistance training
Experimental group
Treatment:
Other: Blood flow restriction resistance training
Resistance training
Active Comparator group
Treatment:
Other: Resistance training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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