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Blood Flow Restriction With Aerobic Exercise in Frail Older Adults

N

National Cheng Kung University

Status

Not yet enrolling

Conditions

Rehabilitation

Treatments

Other: aerobic exercise
Other: aerobic exercise combined with blood flow restriction

Study type

Interventional

Funder types

Other

Identifiers

NCT06155227
B-ER-112-370

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • more than one positive item of Fried frailty phenotype assessment
  • able to walk more than 8 meters independently
  • can understand and follow more than three-step order

Exclusion criteria

  • severe hypertension (>160/100 mmHg)
  • cardiovascular disease, such as myocardial infarction, New York Heart Association class III or IV heart failure, pulmonary hypertension
  • deep vein thrombosis or peripheral vascular disease
  • peripheral neuropathy due to diabetes
  • neuromuscular diseases, such as stroke, Parkinson's disease, etc.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Experimental Group
Experimental group
Treatment:
Other: aerobic exercise combined with blood flow restriction
Control Group
Active Comparator group
Treatment:
Other: aerobic exercise

Trial contacts and locations

1

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Central trial contact

Pei-Yun Lee, PhD

Data sourced from clinicaltrials.gov

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