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NCT Number: NCT06906523

Blood Flow Restriction in Older Adults

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Older Patients

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Católica San Antonio de Murcia

Murcia, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Flow Restriction training

Other

The intensity of the work will be set at around 40% of the maximum intensity that can be executed in a single repetition (1RM). To reach the established intensity, weights, weighted ankle supports and rubber bands of different resistances will be used. Three sets of 8-10 repetitions will be performed with breaks of 1-2 seconds between repetitions and 2-3 minutes between sets. The intensity of the work will be established by applying the rate of perceived exertion. A blood flow restriction device will be used (Akrafit, Valencia, Spain model).

Primary outcomes

  1. Change from baseline muscle power after treatment and at four weeks

    Time frame: Screening visit, within the first seven days after treatment and four weeks follow-up visit

    Muscle power will be assessed with the Sit To Stand 5 times. This tool consists of getting up and sitting down from a chair five times. This instrument has shown high reliability (CCI= 0.95). The unit of measurement is time in seconds, where the shorter the time the greater the muscle power

Secondary outcomes

  1. Change from baseline muscle strength after treatment and at four weeks

    Time frame: Screening visit, within the first seven days after treatment and four weeks follow-up visit

    Muscle strength shall be measured with a pressure dynamometer (Lafayette Manual Muscle Tester 01165). For the measurement of quadriceps muscle strength, the patient shall be placed in a seated position with 90° hip flexion and 75° knee flexion. The dynamometer shall be placed perpendicular to the leg to be assessed, just above the lateral malleolus, maintaining 75° of knee flexion. This assessment has shown good intra-observer reliability (ICC>0.70). This device measures in Newton the force performed by the patient in the requested muscle action. The higher the value, the greater the muscle strength

  2. Change from baseline physical condition after treatment and at four weeks

    Time frame: Screening visit, within the first seven days after treatment and four weeks follow-up visit

    Physical condition will be measured with the Timed Up and Go (TUG). This tool consists of the participant getting up from a chair, walking three metres around an obstacle, walking back to the chair and sitting down again in a timed manner. This instrument has shown high reliability (ICC=0.80-0.99). The unit of measurement is time in seconds, where the shorter the time the greater the physical condition

  3. Change from baseline functionality after treatment and at four weeks

    Time frame: Screening visit, within the first seven days after treatment and four weeks follow-up visit

    Functionality and autonomy will be measured with the Barthel Index. This tool consists of a scale assessing ten items: eating, transferring between chair and bed, personal grooming, toilet use, bathing/showering, transferring, going up and down stairs, dressing and undressing, stool control and urine control. Each item is scored 0 (dependent), 5 (performs with assistance) or 10 (independent) according to the degree to which he/she is able to perform it. This instrument has shown high reliability (ICC= 0.96). The score range is from 0 (total dependence) to 100 (independence).

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

Blood Flow Restriction in Older Adults. A Randomised Single-blind Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 2, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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