Blood Flow Restriction in Older Adults

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

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Older Patients
• Intervention / Treatment: Other: Blood flow restriction training

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain
    • Universidad Católica San Antonio de Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood flow restriction; An exercise protocol will be applied to work on lower limb strength in extension, with the application of BFR, with two 30-minute sessions per week for four weeks. The exercise protocol, based on previous studies in older adults, will consist of three exercises: climbing on a step, knee extension from a seated position and sitting down and getting up from a chair.	Other: Blood flow restriction training; 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).
No Intervention: No intervention; Patients included in the control group will not receive any intervention, maintaining their activities of daily living in the same way as before the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline muscle power after treatment and at four weeks	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	Screening visit, within the first seven days after treatment and four weeks follow-up visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline muscle strength after treatment and at four weeks	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	Screening visit, within the first seven days after treatment and four weeks follow-up visit
Change from baseline physical condition after treatment and at four weeks	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	Screening visit, within the first seven days after treatment and four weeks follow-up visit
Change from baseline functionality after treatment and at four weeks	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).	Screening visit, within the first seven days after treatment and four weeks follow-up visit

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2025
• Primary Completion (Estimated): April 13, 2025
• Study Completion (Estimated): April 15, 2025

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Physical fitness; Older adults; Muscle strength; Functionality; Blood flow restriction; Muscle power
• Other Study ID Numbers: Old-Rest

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No