Clinical trial NCT04507152: Blood Flow Restriction Training in Pre-frail and Frail Older Adults
Official title: Effect of Blood Flow Restriction Resistance Training on Muscle Strength and Functional Performance in Frail Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Keywords: Blood flow restriction
Resistance exercise
Frailty
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 26
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of muscle strength of the lower extremities
timeFrame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
measure: Change of 30 seconds sit to stand
timeFrame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
measure: Change of timed-up-and-go test
timeFrame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
Secondary outcomes:
measure: Change of one-repetition maximum
timeFrame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
measure: Change of muscle mass
timeFrame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
measure: Change of hand grip
timeFrame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
measure: Change of physical activity level
timeFrame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
Other outcomes:
Locations:
city: Tainan city
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References: