Clinical trial NCT06155227: Blood Flow Restriction With Aerobic Exercise in Frail Older Adults
Official title: Effect of Aerobic Exercise Combined With Blood Flow Restriction on Cardiopulmonary Function and Functional Activities in Frail Older Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rehabilitation
Keywords: Blood flow restriction
Aerobic exercise
Frailty
Elderly
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Lower extremity muscle strength
timeFrame: Before training
measure: Lower extremity muscle strength
timeFrame: After completing three-week training
measure: Lower extremity muscle strength
timeFrame: After completing six-week training
measure: Lower extremity muscle strength
timeFrame: At three weeks after completing the training
measure: Lower extremity muscle strength
timeFrame: At six weeks after completing the training
measure: Pulmonary function
timeFrame: Before training
measure: Pulmonary function
timeFrame: After completing three-week training
measure: Pulmonary function
timeFrame: After completing six-week training
measure: Pulmonary function
timeFrame: At three weeks after completing the training
measure: Pulmonary function
timeFrame: At six weeks after completing the training
measure: Timed up and go test
timeFrame: Before training
measure: Timed up and go test
timeFrame: After completing three-week training
measure: Timed up and go test
timeFrame: After completing six-week training
measure: Timed up and go test
timeFrame: At three weeks after completing the training
measure: Timed up and go test
timeFrame: At six weeks after completing the training
measure: 2 minutes step test
timeFrame: Before training
measure: 2 minutes step test
timeFrame: After completing three-week training
measure: 2 minutes step test
timeFrame: After completing six-week training
measure: 2 minutes step test
timeFrame: At three weeks after completing the training
measure: 2 minutes step test
timeFrame: At six weeks after completing the training
measure: 6 minutes walking test
timeFrame: Before training
measure: 6 minutes walking test
timeFrame: After completing three-week training
measure: 6 minutes walking test
timeFrame: After completing six-week training
measure: 6 minutes walking test
timeFrame: At three weeks after completing the training
measure: 6 minutes walking test
timeFrame: At six weeks after completing the training
measure: Walking speed
timeFrame: Before training
measure: Walking speed
timeFrame: After completing three-week training
measure: Walking speed
timeFrame: After completing six-week training
measure: Walking speed
timeFrame: At three weeks after completing the training
measure: Walking speed
timeFrame: At six weeks after completing the training
Secondary outcomes:
measure: Body composition
timeFrame: Before training
measure: Body composition
timeFrame: After completing six-week training
measure: Body composition
timeFrame: At three weeks after completing the training
measure: Body composition
timeFrame: At six weeks after completing the training
Other outcomes:
Locations:
city: Tainan city
country: Taiwan
facility: Department of Physical Therapy
Study officials:
References: