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Blood Flow Restriction With Aerobic Exercise in Frail Older Adults

Effect of Aerobic Exercise Combined With Blood Flow Restriction on Cardiopulmonary Function and Functional Activities in Frail Older Adults

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06155227
Enrollment
60
Registered
2023-12-04
Start date
2023-12-20
Completion date
2025-12-31
Last updated
2023-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rehabilitation

Keywords

Blood flow restriction, Aerobic exercise, Frailty, Elderly

Brief 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.

Interventions

aerobic exercise combined with blood flow restriction for 18 sessions

OTHERaerobic exercise

aerobic exercise for 18 sessions

Sponsors

National Cheng Kung University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Timed up and go testBefore trainingThis test measure the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down
Lower extremity muscle strengthBefore trainingUse an hand-held dynamometer to measure bilateral lower limb muscle strength
Pulmonary functionBefore trainingPulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second
Walking speedBefore trainingTest the gait speed under preferred and maximum speed walking
2 minutes step testBefore trainingNumber of steps completed in 2 min
6 minutes walking testBefore trainingRecord the distance walked in 6 minutes

Secondary

MeasureTime frameDescription
Body compositionBefore trainingUse Inbody 270 to measure skeletal muscle mass of the whole body and the four extremities

Countries

Taiwan

Contacts

Primary ContactPei-Yun Lee, PhD
peiyunlee@mail.ncku.edu.tw886-6-2353535

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026