Blood Flow Restriction With Aerobic Exercise in Frail Older Adults - Trial NCT06155227
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Study Focus
Sponsor & Location
National Cheng Kung University
Timeline & Enrollment
N/A
Dec 01, 2023
Dec 01, 2025
Primary Outcome
Lower extremity muscle strength,Lower extremity muscle strength,Lower extremity muscle strength,Lower extremity muscle strength,Lower extremity muscle strength,Pulmonary function,Pulmonary function,Pulmonary function,Pulmonary function,Pulmonary function,Timed up and go test,Timed up and go test,Timed up and go test,Timed up and go test,Timed up and go test,2 minutes step test,2 minutes step test,2 minutes step test,2 minutes step test,2 minutes step test,6 minutes walking test,6 minutes walking test,6 minutes walking test,6 minutes walking test,6 minutes walking test,Walking speed,Walking speed,Walking speed,Walking speed,Walking speed
Summary
Background:Frailty is most often defined as a syndrome of physiological decline in late life,
 characterized by marked vulnerability to adverse health outcomes. Exercise intervention
 including aerobic exercise training has been proven to be effective in improving aerobic
 capacity and frail condition in elderly. Recently a novel training method using blood flow
 restriction (BFR) combined with aerobic exercise has shown positive effects on muscles
 strength and physical function in healthy elderly. This training method only required lower
 exercise intensity compared with traditional aerobic exercise to observe improvement.
 However, it is still unclear whether aerobic exercise training combined with BFR could also
 improve aerobic capacity and physical function in frail older adults. Therefore, the aim of
 this study will be to investigate the effect of aerobic exercise combined with BFR on
 cardiopulmonary function and functional activities in frail older adults.
 
 Method: This study will be an assessor-blind randomized controlled trial.Participants aged
 over 65 years old with more than one item positive of Fried frailty phenotype assessment
 results will be recruited from the hospital and nearby communities. The participants will be
 randomly assigned to one of two training groups, aerobic exercise with BFR and only aerobic
 exercise. The exercise will be executed 30 minutes/session, three sessions/week for six
 weeks. Cardiopulmonary function and performance of functional activities will be assessed at
 pre-training, 3 weeks after training, post-training, and 3- and 6-week follow-up.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06155227
Non-Device Trial