Clinical trial NCT06906523: Blood Flow Restriction in Older Adults
Official title: Blood Flow Restriction in Older Adults. A Randomised Single-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Older Patients
Keywords: Blood flow restriction
Older adults
Muscle power
Muscle strength
Functionality
Physical fitness
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 18
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Introduction. From the age of 80 onwards, more than 50% of people suffer from sarcopenia. The loss of muscle strength leads to a loss of muscle power, impairing functionality and preventing the correct performance of activities of daily living.

Objective. To analyse the efficacy of blood flow restriction in older adult patients by evaluating changes in the variables muscle power and strength, physical condition and functionality of the lower limbs.

Material and method. Randomised single-blind clinical study. Thirty-six older adults will be recruited and randomised to the experimental and control groups. The intervention will have a duration of 4 weeks, with 2 weekly sessions. The intervention will consist of an intervention by performing 3 quadriceps strength exercises, with a 40% restriction. The primary variable of the study will be muscle power (Sit To Stand 5 times) and the secondary variables will be muscle strength (dynamometry), physical condition (Timed Up and Go) and functionality and autonomy (Barthel index)


Eligibility criteria: Inclusion Criteria:

* Older adults aged 65 to 80 years
* Independent for standing and walking with the help of assistive devices such as cane and walker
* Both genders
* Normotensive or hypertensive with controlled BP (systolic blood pressure \<140 mmHg)
* Sign the informed consent form.

Exclusion Criteria:

* People dependent for the performance of activities of daily living.
* People with cognitive impairments that limit the performance of the intervention or assessments.
* Persons undergoing total hip or knee arthroplasty
* Persons receiving physiotherapy treatment at the time of the study
* History of deep vein thrombosis (DVT) or pulmonary embolism
* History of myocardial infarction or stroke

Primary outcomes:
measure: Change from baseline muscle power after treatment and at four weeks
timeFrame: Screening visit, within the first seven days after treatment and four weeks follow-up visit
Secondary outcomes:
measure: Change from baseline muscle strength after treatment and at four weeks
timeFrame: Screening visit, within the first seven days after treatment and four weeks follow-up visit
measure: Change from baseline physical condition after treatment and at four weeks
timeFrame: Screening visit, within the first seven days after treatment and four weeks follow-up visit
measure: Change from baseline functionality after treatment and at four weeks
timeFrame: Screening visit, within the first seven days after treatment and four weeks follow-up visit
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad Católica San Antonio de Murcia
Study officials:
References: