Clinical trial NCT05209685: Blood Flow Restriction on Functional Mobility in Pre-frail Older Adults
Official title: Effect of Blood Flow Restriction Resistance Exercise on Functional Mobility in Pre-Frail Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Keywords: pre-frail, blood flow restriction, functional mobility
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 54
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the effect of blood flow restriction with resistance exercise on functional mobility in pre-frail older adults. It is hypothesized that receiving resistance exercise with blood flow restriction will exhibit better improvement on functional mobility than only receiving resistance exercise in pre-frail older adults.

Detailed description: Participants aged over 65 years old with less than two items positive of Fried frailty phenotype assessment result will be recruited. The participants will be randomly assigned to two training groups, blood flow restriction resistance exercise and traditional resistance exercise. Both groups will receive the training 30 minutes/session, two sessions/week for six weeks. Muscle strength of the lower extremities and functional mobility tests will be used to assess outcomes at pre-training, 3-week after training, post-training, and one-month and two-month follow-up.

Eligibility criteria: Inclusion Criteria:

* Aged over 65 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 Timed-Up and Go (TUG) test
timeFrame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
measure: Change of 30 seconds sit to stand
timeFrame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
measure: Change of muscle strength of the lower extremities
timeFrame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Secondary outcomes:
measure: Change of one-repetition maximum
timeFrame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
measure: Change of muscle mass
timeFrame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
measure: Change of hand grip strength
timeFrame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Department of Physical Therapy
Study officials:
References: